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ABSTRACT: Women undergoing general anesthesia for dilatation and curettage have a high risk for postoperative nausea and vomiting. We therefore evaluated the efficacy and safety of ramosetron, a new compound having serotonin receptor antagonist activity, for preventing nausea and vomiting in termination of pregnancy. Eighty women scheduled for dilatation and curettage received, in a randomized, double-blind manner, an intravenous placebo or ramosetron at three different doses (0.15 mg, 0.3 mg, 0.6 mg) at the end of surgery (n = 20 per group). Emetic episodes and safety were assessed. The percentage of patients who were emesis-free (no nausea, no retching, no vomiting) during 0-24 h after anesthesia was 55% with ramosetron 0.15 mg (P = 0.5), 85% with ramosetron 0.3 mg (P = 0.02), and 90% with ramosetron 0.6 mg (P = 0.007), compared with 50% in the placebo group. No clinically serious adverse events due to the study drugs were observed in any group. Our results suggest that ramosetron 0.3 mg is an effective antiemetic for prophylaxis against emetic symptoms after dilatation and curettage. Increasing the dose to 0.6 mg provides no further benefit.
International Journal of Obstetric Anesthesia 02/2004; 13(1):15-8. · 1.39 Impact Factor
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ABSTRACT: Postoperative vomiting occurs frequently after strabismus surgery in children. Granisetron, a selective 5-hydroxytryptamine type 3 receptor antagonist, is effective for the prevention of vomiting following paediatric strabismus surgery. Ramosetron, another new antagonist of 5-hydroxytryptamine type 3 receptor, has more potent and longer acting properties than granisetron against cisplatin induced emesis. This study was undertaken to compare the efficacy and safety of granisetron and ramosetron for the prevention of vomiting following strabismus surgery in children.
In a randomised, double blinded manner 80 children, aged 4-10 years, received intravenously granisetron 40 microg/kg or ramosetron 6 microg/kg (n=40 each) at the end of surgery. A standard general anaesthetic technique and postoperative analgesia were used. Emetic episodes and safety assessment were performed during the first 24 hours and the next 24 hours after anaesthesia.
The percentage of patients who were emesis free during 0-24 hours after anaesthesia was 85% with granisetron and 90% with ramosetron, respectively (p = 0.369); the corresponding rate during 24-48 hours after anaesthesia was 70% and 95% (p = 0.003). No clinically serious adverse events caused by the study drug were observed in any of the groups.
Prophylactic antiemetic therapy with ramosetron is comparable with granisetron for the prevention of vomiting during 0-24 hours after anaesthesia in children undergoing strabismus surgery. During 24-48 hours after anaesthesia, ramosetron is more effective than granisetron for prophylaxis against postoperative vomiting.
British Journal of Ophthalmology 07/2001; 85(6):670-2. · 2.90 Impact Factor
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ABSTRACT: To evaluate the efficacy and safety of oral granisetron for the prevention of postoperative nausea and vomiting after breast surgery.
Prospective, randomised, double-blind, placebo-controlled study.
University affiliated hospital, Japan.
100 women listed for partial or modified radical mastectomy with or without axillary dissection.
Patients were given either placebo or granisetron in three different doses (1 mg, 2 mg, 4 mg) orally 1 hour preoperatively (n = 25 in each group). A standard general anaesthetic technique and postoperative analgesia were used.
All episodes of nausea and vomiting during the first 24 hours after anaesthesia.
Complete response, defined as no nausea and vomiting and no need for a "rescue" antiemetic, during the first 24 hours after anaesthesia was recorded in 13 (52%) with placebo, 14 (56%) with granisetron 1 mg, 22 (88%) with 2 mg, and 22 (88%) with 4 mg, respectively (p = 0.006, Fisher's exact test). No clinically serious adverse events were seen in any of the groups.
Preoperative oral granisetron, in doses of more than 2 mg, is effective for the prevention of postoperative nausea and vomiting in women undergoing general anaesthesia for breast surgery.
The European Journal of Surgery 03/2001; 167(3):184-7.
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ABSTRACT: Laparoscopic cholecystectomy is associated with a relatively high incidence of postoperative nausea and vomiting when no prophylactic antiemetic is given. This study assesses the efficacy and safety of oral granisetron hydrochloride for the prevention of nausea and vomiting after laparoscopic cholecystectomy.
A prospective, randomized, double-blind, placebo-controlled study.
University teaching hospital.
The study comprised 120 patients, 92 women and 28 men, undergoing laparoscopic cholecystectomy.
Patients received orally either placebo or granisetron at 3 different doses (1 mg, 2 mg, and 4 mg; n = 30 of each) 60 minutes before surgery. A standard general anesthetic technique and postoperative analgesia were used.
Emetic episodes were recorded during the first 24 hours after anesthesia.
The incidence of patients who were emesis-free 24 hours after anesthesia was 60% with 1 mg of granisetron (P =.40), 83% with 2 mg of granisetron (P =.01), and 83% with 4 mg of granisetron (P =.01), compared with placebo (53%). No clinically important adverse effects were observed in any of the groups.
Preoperative oral granisetron in doses higher than 2 mg is effective for the prevention of nausea and vomiting after laparoscopic cholecystectomy.
Archives of Surgery 02/2001; 136(1):101-4. · 4.24 Impact Factor
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ABSTRACT: In a prospective, randomized, double-blinded, placebo-controlled trial, we evaluated the efficacy of ramosetron at three different doses (0.15, 0.3, and 0.6 mg) for the prevention of postoperative nausea and vomiting (PONV) after gynecological surgery. One hundred twenty women, ASA physical status I or II, aged 21-63 yr, received IV either placebo or ramosetron 0.15, 0.3, or 0.6 mg (n = 30 of each) at the completion of surgery. A standard general anesthetic technique and postoperative analgesia were used. A complete response, defined as no PONV and no need for another rescue antiemetic, during 0-3 h after anesthesia occurred in 40%, 47%, 87%, and 90% of patients who had received placebo and ramosetron 0.15, 0.3, and 0.6 mg, respectively. Corresponding results during 3-24 h after anesthesia were 43%, 50%, 87%, and 90%, and 24-48 h after anesthesia were 50%, 53%, 90%, and 93% (P < 0.05). Patients who had received ramosetron 0.3 or 0.6 mg were satisfied compared with those who had received placebo (P < 0.05). There were no serious clinical adverse events caused by the study drug in any of the groups. In conclusion, ramosetron 0.3 mg is an effective antiemetic for preventing PONV during 0-48 h after anesthesia in female patients undergoing gynecological surgery. Increasing the dose to 0.6 mg provided no further benefit. IMPLICATIONS: This randomized, double-blinded, placebo-controlled trial in 120 women found the effective dose of ramosetron for preventing postoperative nausea and vomiting after gynecological surgery to be 0.3 mg.
Anesthesia & Analgesia 03/2000; 90(2):472-5. · 3.29 Impact Factor
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ABSTRACT: Dexamethasone decreases chemotherapy-induced emesis when added to an antiemetic regimen. This study was undertaken to evaluate the efficacy of granisetron/dexamethasone combination for preventing postoperative nausea and vomiting (PONV) after lapIaroscopic cholecystectomy (LC). In a prospective, randomized, double-blind manner, 120 patients (83 females), aged 25-65 years, were assigned to receive granisetron 40 microg kg-1 alone or granisetron 40 microg kg-1 plus dexamethasone 8 mg (n=60 of each) intravenously immediately before the induction of anaesthesia. A standardized general anaesthetic procedure and postoperative analgesia were used. A complete response, defined as no PONV and no need for another rescue antiemetic, during 0-3 h after anaesthesia was 83% with granisetron and 98% with granisetron plus dexamethasone, respectively (P=0.008); the corresponding incidence during 3-24 h after anaesthesia was 83% and 98% (P=0.008). No clinically important adverse events were observed in any of the group. In conclusion, prophylactic therapy with granisetron/dexamethasone combination is more effective than granisetron alone for the prevention of PONV after LC.
European Journal of Anaesthesiology 02/2000; 17(1):64-8. · 2.23 Impact Factor
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ABSTRACT: The aim of this study was to evaluate granisetron, droperidol, and metoclopramide for efficacy and safety in the treatment of established postoperative nausea and vomiting after major gynecologic surgery.
One hundred twenty postoperative female patients were monitored for the first 3 hours after anesthesia in the postanesthesia care unit and for the next 24 hours after anesthesia in the ward. Patients who had postoperative nausea and vomiting within the first 3 hours after anesthesia received intravenously, in a randomized double-blind manner, 40 microg/kg granisetron, 20 microg/kg droperidol, or 0.2 mg/kg metoclopramide. Patients were then observed for 24 hours after drug administration.
Complete control of established postoperative nausea and vomiting, defined as no emesis and no need for another rescue antiemetic medication, was more frequent among the patients who had received granisetron (88%) than among those who had received droperidol (55%) or metoclopramide (50%) (P <.05). The severity of nausea was less in patients who had received granisetron than in those who had received droperidol or metoclopramide (P <.05). No clinically adverse events were observed in any of the groups.
Granisetron is more effective than droperidol or metoclopramide for the treatment of established postoperative nausea and vomiting during the first 3 hours after anesthesia in patients undergoing major gynecologic operations.
American Journal of Obstetrics and Gynecology 02/2000; 182(1 Pt 1):13-6. · 3.47 Impact Factor
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ABSTRACT: This study was designed to evaluate the effects of diazepam and clonidine orally given preoperatively on cardiovascular responses to tracheal extubation in children. Fifty children, ASA physical status I, aged 4-10 years, undergoing minor elective surgery (inguinal hernia, phimosis) received orally, in a randomized, double-blind manner, diazepam 0.4 mg.kg-1 or clonidine 4 microgram.kg-1 (n=25 of each). These drugs were administered 105 min before an inhalational induction of anaesthesia. The same standard general anaesthetic technique was employed throughout. The maximum changes in heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP) were less in patients who had received clonidine than in those who had received diazepam (HR, 12 vs 24; SBP, 14 vs 26; DBP, 9 vs 16; mean, P < 0.05). In conclusion, compared to diazepam given orally, pretreatment with oral clonidine attenuates haemodynamic changes associated with tracheal extubation in children.
Pediatric Anesthesia 02/2000; 10(1):65-7. · 2.10 Impact Factor
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ABSTRACT: To compare the efficacy of ramosetron with granisetron for the prevention of postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy.
In a randomized, double-blind study, 80 female inpatients received 3 mg granisetron or 0.3 mg ramosetron i.v. (n=40 of each) at the completion of surgery The standardized anesthetic included isoflurane and nitrous oxide in oxygen.
Complete response, defined as no PONV, during the first 24 hr (0-24 hr) after anesthesia was 85% with granisetron and 93% with ramosetron, respectively (P=0.241); the corresponding incidence during the next 24 hr (24-48 hr) after anesthesia was 63% and 90% (P=0.004). No clinically important adverse events due to the study drug were observed in any of the groups.
Ramosetron was more effective than granisetron for prevention of PONV during 0-48 hr after anesthesia for laparoscopic cholecystectomy.
Canadian Journal of Anaesthesia 11/1999; 46(10):991-3. · 2.35 Impact Factor
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ABSTRACT: We have compared the efficacy and safety of combined granisetron and droperidol with each anti-emetic alone for preventing post-operative nausea and vomiting after thyroidectomy. In a prospective, randomized, double-blind study, 180 women received granisetron 40 micrograms kg-1, droperidol 20 micrograms kg-1, or granisetron 40 micrograms kg-1 plus droperidol 20 micrograms kg-1 (n = 60 of each) intravenously immediately before induction of anaesthesia. A standard general anaesthetic technique and post-operative analgesia were used. A complete response, defined as no post-operative nausea and vomiting and no need for another rescue anti-emetic, during the first 24 h after anaesthesia occurred in 88%, 60% and 98% of patients who had received granisetron, droperidol and granisetron plus droperidol (P < 0.05; overall Fisher's exact probability test). No clinically important adverse events due to the drugs were observed in any of the groups. In summary, prophylactic use of combined granisetron and droperidol is more effective than each drug alone for the prevention of post-operative nausea and vomiting in female patients undergoing thyroidectomy.
European Journal of Anaesthesiology 10/1999; 16(10):688-91. · 2.23 Impact Factor
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ABSTRACT: In a prospective, randomized, double-blinded study, we evaluated the efficacy of granisetron and ramosetron for preventing postoperative nausea and vomiting (PONV) in major gynecologic surgery. One hundred twenty patients, ASA physical status I or II, aged 23-65 yr, received i.v. granisetron 2.5 mg or ramosetron 0.3 mg (n = 60 each) at the end of surgery. A standard general anesthetic technique and postoperative analgesia were used. The incidence of a complete response, defined as no PONV and no need for another rescue medication, 0-3 h after anesthesia was 87% with granisetron and 90% with ramosetron; the corresponding incidence 3-24 h after anesthesia was 85% and 90%; the corresponding incidence 24-48 h after anesthesia was 70% and 92% (P < 0.05). No clinically serious adverse events due to the drugs were observed in any of the groups. In conclusion, prophylactic therapy with ramosetron is more effective than granisetron for the longterm prevention of PONV after major gynecologic surgery. Implications: We compared the efficacy of granisetron and ramosetron for preventing postoperative nausea and vomiting in major gynecologic surgery. Prophylactic therapy with ramosetron was more effective than granisetron for preventing postoperative nausea and vomiting 24-48 h after anesthesia.
Anesthesia & Analgesia 09/1999; 89(2):476-9. · 3.29 Impact Factor
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ABSTRACT: This study was undertaken to compare the efficacy and safety of granisetron, a 5-hydroxytryptamine type 3 receptor antagonist, and dexamethasone and each drug alone for the prevention of post-operative vomiting by children, with no history of motion sickness and/or previous post-operative vomiting, undergoing general inhalational anaesthesia for surgery (inguinal hernia and phimosis). In a randomized, double-blind manner, 150 children, ASA physical status 1, aged 4-10 years, were assigned to receive granisetron 40 mg kg-1, dexamethasone 150 mg kg-1, or granisetron 40 mg kg-1 plus dexamethasone 150 mg kg-1 intravenously immediately after inhalation induction of anaesthesia (n = 50 of each). A complete response, defined as no emesis and no need for another rescue anti-emetic during the first 24 h after anaesthesia, was 86% with granisetron, 68% with dexamethasone and 98% with granisetron plus dexamethasone, respectively (P < 0.05; overall Fisher's exact probability test). No clinically serious adverse events were observed in any of the groups. In conclusion, prophylactic therapy with combined granisetron and dexamethasone was more effective than was each anti-emetic alone for the prevention of vomiting after paediatric surgery.
European Journal of Anaesthesiology 07/1999; 16(6):376-9. · 2.23 Impact Factor
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ABSTRACT: We compared the efficacy of granisetron plus dexamethasone with that of granisetron alone for preventing nausea and vomiting in parturients undergoing cesarean section under spinal anesthesia. In a randomized, double-blinded manner, 120 patients received either granisetron 3 mg (Group I, n = 60) or granisetron 3 mg plus dexamethasone 8 mg (Group II, n = 60) IV immediately after clamping of the fetal umbilical cord. A complete response, defined as no emetic symptoms and no need for another rescue antiemetic medication in the intraoperative, postdelivery period was 83% in Group I and 98% in Group II (P = 0.008); the corresponding rates during the first 24 h after surgery was 85% and 98% (P = 0.016). No clinically serious adverse events were observed in any of the groups. In conclusion, the prophylactic use of a granisetron/dexamethasone combination is more effective than granisetron alone for reducing nausea and vomiting in patients during and after spinal anesthesia for cesarean section. IMPLICATIONS: Intraoperative, postdelivery, and postoperative nausea and vomiting are distressing to patients undergoing cesarean section under spinal anesthesia. The combination of granisetron plus dexamethasone was evaluated and found to be effective for preventing these emetic symptoms.
Anesthesia & Analgesia 07/1999; 88(6):1346-50. · 3.29 Impact Factor
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ABSTRACT: In a prospective, randomized, double-blinded trial, we evaluated the efficacy of two antiemetics given orally, granisetron and perphenazine, for preventing postoperative vomiting after tonsillectomy with or without adenoidectomy in children. One hundred pediatric patients, ASA physical status I, aged 4-10 yr, received either granisetron 40 microg/kg or perphenazine 70 microg/kg (n = 50 each) orally 1 h before surgery. We used a standard general anesthetic technique. The rate of complete response, defined as no emesis and no need for rescue antiemetic medication, during 0-3 h after anesthesia was 86% with granisetron and 60% with perphenazine; the corresponding rate 3-24 h after anesthesia was 86% and 62%, respectively (P < 0.05). No serious adverse events were observed in any of the groups. In conclusion, preoperative oral granisetron is more effective than perphenazine for preventing postoperative vomiting in children undergoing tonsillectomy with or without adenoidectomy. IMPLICATIONS: We compared the efficacy of granisetron and perphenazine given orally for preventing postoperative vomiting after tonsillectomy with or without adenoidectomy in children. Preoperative oral granisetron was more effective than perphenazine.
Anesthesia & Analgesia 06/1999; 88(6):1298-301. · 3.29 Impact Factor
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ABSTRACT: We have compared the efficacy of granisetron with perphenazine in the prevention of vomiting after tonsillectomy with or without adenoidectomy in children. In a prospective, randomized, double-blind study, 90 paediatric patients, ASA I, aged 4-10 years, received granisetron 40 mg kg-1 or perphenazine 70 mg kg-1 (n = 45 each) intravenously immediately after an inhalation induction of anaesthesia. A standard general anaesthetic technique was employed throughout. A complete response, defined as no emesis with no need for another rescue antiemetic, during the first 3 h (0-3 h) after anesthesia was 87% with granisetron and 78% with perphenazine (P = 0.204). The corresponding incidence during the next 21 h (3-24 h) after anaesthesia was 87% and 62% (P = 0.007). No clinically serious adverse events were observed in any of the groups. We conclude that granisetron is a better anti-emetic than perphenazine for the long-term prevention of post-operative vomiting in children undergoing general anaesthesia for tonsillectomy.
European Journal of Anaesthesiology 06/1999; 16(5):304-7. · 2.23 Impact Factor
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ABSTRACT: To evaluate the efficacy and safety of granisetron-droperidol combination for the prevention of postoperative nausea and vomiting (PONV) after middle ear surgery.
Prospective, randomized, double-blind study.
University hospital.
150 ASA physical status I patients (108 females, 42 males) scheduled for elective middle ear surgery.
Patients received granisetron 40 micrograms/kg (n = 50), droperidol 20 micrograms/kg (n = 50), or granisetron 40 micrograms/kg plus droperidol 20 micrograms/kg (n = 50) intravenously immediately before induction of anesthesia.
A standard general anesthetic technique and postoperative analgesia were used throughout the study. A complete response, defined as no PONV and no need for another rescue antiemetic, from 0 to 3 hours after anesthesia occurred in 78%, 56%, and 94% of patients who had received granisetron, droperidol, and granisetron plus droperidol, respectively. The corresponding incidence between 3 and 24 hours after anesthesia was 80%, 52% and 94%. Thus, a complete response within the first 24-hour postanesthetic period was greater in patients receiving granisetron-droperidol combination than in those receiving granisetron alone or droperidol alone (p < 0.05). No clinically adverse events were observed in any of the groups.
A combination of granisetron and droperidol is more effective than droperidol or granisetron alone for the prevention of PONV after middle ear surgery.
Journal of Clinical Anesthesia 04/1999; 11(2):108-12. · 1.21 Impact Factor
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ABSTRACT: The incidence of postoperative nausea and vomiting (PONV) following laparoscopic cholecystectomy (LC) is relatively high when no prophylactic antiemetic is given. We have studied the efficacy of a commonly used and well-established antiemetic, droperidol, for the prevention of PONV in patients undergoing LC.
In a randomized, double-blind, placebo-controlled study, 60 patients received placebo (saline) or droperidol 50 microg.kg(-1) (maximum dose, 2.5 mg) intravenously immediately before the induction of anesthesia (n = 30 of each). A standard general anesthetic technique was employed throughout.
A complete response, defined as no PONV and no need for another rescue antiemetic medication during the first 24 h after anesthesia, was 57% and 83% in patients who had received placebo and droperidol 50 microg.kg(-1), respectively ( P < 0.05). No clinically serious adverse events were observed in any of the groups.
Prophylactic antiemetic therapy with droperidol 50 microg.kg(-1) (maximum dose, 2.5 mg) is highly effective for preventing PONV after LC.
Journal of Anesthesia 01/1999; 13(3):140-3. · 0.83 Impact Factor
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ABSTRACT: This study was undertaken to compare the efficacy of granisetron plus droperidol with each antiemetic alone for the prevention of vomiting after paediatric strabismus surgery. In a prospective, randomized, double-blinded trial, 120 ASA physical status I children, aged 4-10 years, received granisetron 40 microg.kg- 1, droperidol 50 microg.kg- 1, granisetron 40 microg.kg- 1 plus droperidol 50 microg.kg- 1 (n=40 of each) intravenously after an inhalation induction of anaesthesia. A complete response, defined as no vomiting, no retching and no need for another rescue antiemetic medication, during 0-3 h after anaesthesia was 80% with granisetron, 45% with droperidol and 98% with granisetron plus droperidol, respectively; the corresponding incidence during 3-24 h after anaesthesia was 78%, 38% and 98% (P< 0.05; overall chi-squared test with Yates continuity correction). No clinically important adverse events were observed in any of the groups. In conclusion, a combination of granisetron and droperidol was more effective than granisetron or droperidol as a sole antiemetic for the prevention of postoperative vomiting in children undergoing strabismus repair.
Pediatric Anesthesia 01/1999; 9(4):329-33. · 2.10 Impact Factor
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ABSTRACT: In this prospective, randomized, double-blinded study, we evaluated the efficacy of the oral antiemetics, granisetron and domperidone, for the prevention of postoperative nausea and vomiting (PONV) in 100 women undergoing major gynecologic surgery. Patients received either granisetron 2 mg or domperidone 20 mg (n = 50 in each group) orally 1 h before surgery. Standardized anesthetic techniques and postoperative analgesia regimens were used. Complete response (defined as no PONV and no administration of rescue antiemetic medication) for 0-3 h after anesthesia was 88% with granisetron and 52% with domperidone; the corresponding incidence for 3-24 h after anesthesia was 86% and 48% (P < 0.05). No clinically important adverse events due to the drugs were observed in any of the groups. In conclusion, the efficacy of preoperative oral granisetron is superior to that of domperidone for the prevention of PONV after major gynecologic surgery. IMPLICATIONS: We compared the efficacy of granisetron and domperidone administered orally for the prevention of postoperative nausea and vomiting in women undergoing gynecologic surgery. Preoperative oral granisetron was more effective than domperidone.
Anesthesia & Analgesia 01/1999; 87(6):1404-7. · 3.29 Impact Factor
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ABSTRACT: A history of motion sickness is one of the patient-related factors associated with postoperative emesis. This prospective, randomized, double-blind, placebo-controlled study was undertaken to assess the efficacy of granisetron, a selective 5-hydroxytryptamine type 3 receptor antagonist, for preventing postoperative vomiting after tonsillectomy in 120 children with (n = 60) and without (n = 60) a history of motion sickness. Patients received a single dose of granisetron (40 micrograms.kg-1) or placebo (saline) (n = 30 of each) intravenously after an inhalation induction of anaesthesia. A complete response, defined as no vomiting, no retching and no need for another rescue medication, during the first 24 h after anaesthesia was 77% and 13% in patients with a history of motion sickness who had received granisetron or placebo, respectively; the corresponding incidence was 83% and 40% in those without it (P < 0.05; chi 2 test with Yates' continuity correction). No clinically serious adverse effects due to the study drug were observed in any of the groups. In conclusion, prophylactic antiemetic therapy with granisetron is effective for preventing postoperative emesis in children with a history of motion sickness as well as in those without it.
Pediatric Anesthesia 01/1999; 9(6):527-30. · 2.10 Impact Factor
