Detail information
ID ENCL000135
Year 2002
Disease Postoperative Nausea and Vomiting
Surgery Plastic Surgery Procedures
Acupoint
Acupoint Code
Neiguan PC6
Side
Description P6
Experimental Description A single-center, randomized, double-blind, placebo- and sham-controlled study design was conducted to compare three prophylactic antiemetic treatment regimens in 120 outpatients undergoing plastic surgery procedures with routine low-dose droperidol prophylaxis: (1) ondansetron (n = 40), 4 mg intravenous ondansetron and a sham ReliefBand; (2) acustimulation (n = 40), 2 ml intravenous saline and an active ReliefBand; and (3) combination (n=40), 4 mg intravenous ondansetron and an active ReliefBand.
Sample Count 120
Age ＞18
Control
Placebo
ondansetron(n=40);
Experiment acustimulation(n=40);combination(n=40)
Indicator Postoperative Nausea and Vomiting(PONV) The need for antiemetic rescue Recovery times Quality of recovery score Time to resumption of normal diet Patient satisfaction
Auxiliary Medication All patients underwent a standardized general anesthetic technique consisting of propofol for induction and sevoflurane in combination with remifentanil for maintenance of anesthesia. Perioperative opioid analgesics were also standardized in all patients. All patients received antiemetic prophylaxis with droperidol, 0.625 mg intravenously, after induction of anesthesia. On arrival in the postanesthesia care unit, the patients received either 4 mg intravenous ondansetron (ondansetron and combination groups) or an equal volume of intravenous saline (acustimulation group) from identical-appearing syringes.
Stimulation Method TEAS
Anesthesia Method
GA
Clinical Trial Type random
Adverse Effects Patients who had taken any antiemetic medication within 24 h prior to the operation, were pregnant, were experiencing menstrual symptoms, were using a perma_x005fnent cardiac pacemaker, had previous experience with acustimulation therapies, or had experienced vomiting or retching within 24 h before surgery were excluded.
Contraindications Pregnant, experiencing menstrual symptoms, using perma_x005fnent cardiac pacemaker
Effector Use of the ReliefBand in combination with ondansetron significantly reduced nausea (20 vs. 50%), vomiting (0 vs. 20%), and the need for rescue antiemetics (10 vs. 37%) compared with ondansetron alone at 24 h after surgery. Furthermore, the ability to resume a normal diet (74 vs. 35%) within 24 h after surgery was significantly improved when the ReliefBand was used to supplement ondansetron (vs. ondansetron alone). Finally, the quality of recovery (90 +/- 10 vs.70 +/- 20) and patient satisfaction (94 +/- 10 vs. 75 +/- 22) scores were significantly higher in the combination group the ondansetron group. There were no significant differences between the ReliefBand and ondansetron when administered as adjuvants to droperidol for antiemetic prophylaxis.
Literature
PMID 12411789
Title Comparative efficacy of acustimulation (ReliefBand) versus ondansetron (Zofran) in combination with droperidol for preventing nausea and vomiting.
Abstract BACKGROUND: Antiemetic drugs are costly, are associated with variable efficacy, and can produce unwanted side effects when used for prophylaxis against postoperative nausea and vomiting. This clinical study was designed to compare the efficacy of transcutaneous electrical acupoint stimulation using a ReliefBand to ondansetron (Zofran) when utilized alone or in combination for preventing postoperative nausea and vomiting after plastic surgery. METHODS: A single-center, randomized, double-blind, placebo- and sham-controlled study design was conducted to compare three prophylactic antiemetic treatment regimens in 120 outpatients undergoing plastic surgery procedures with routine low-dose droperidol prophylaxis: (1) ondansetron (n = 40), 4 mg intravenous ondansetron and a sham ReliefBand; (2) acustimulation (n = 40), 2 ml intravenous saline and an active ReliefBand; and (3) combination (n = 40), 4 mg intravenous ondansetron and an active ReliefBand. The incidences of postoperative nausea and vomiting, as well as the need for ""rescue"" antiemetics, were determined at specific time intervals for up to 72 h after surgery. The outcome variables assessed included recovery times, quality of recovery score, time to resumption of normal diet, and patient satisfaction with the prophylactic antiemetic therapy. RESULTS: Use of the ReliefBand in combination with ondansetron significantly reduced nausea (20 vs. 50%), vomiting (0 vs. 20%), and the need for rescue antiemetics (10 vs. 37%) compared with ondansetron alone at 24 h after surgery. Furthermore, the ability to resume a normal diet (74 vs. 35%) within 24 h after surgery was significantly improved when the ReliefBand was used to supplement ondansetron (vs. ondansetron alone). Finally, the quality of recovery (90 +/- 10 vs.70 +/- 20) and patient satisfaction (94 +/- 10 vs. 75 +/- 22) scores were significantly higher in the combination group the ondansetron group. There were no significant differences between the ReliefBand and ondansetron when administered as adjuvants to droperidol for antiemetic prophylaxis. CONCLUSIONS: The ReliefBand compared favorably to ondansetron (4 mg intravenously) when used for prophylaxis against postoperative nausea and vomiting. Furthermore, the acustimulation device enhanced the antiemetic efficacy of ondansetron after plastic surgery."
Souce Anesthesiology. 2002 Nov;97(5):1075-81. doi: 10.1097/00000542-200211000-00008.