BACKGROUND: This study was designed to evaluate transcutaneous electrical acupoint stimulation (acustimulation) using the ReliefBand compared with ondansetron for the treatment of established postoperative nausea and vomiting (PONV) after outpatient laparoscopic surgery. METHODS: After the authors obtained institutional review board approval and written informed consent, 268 outpatients were enrolled in this randomized, double-blind, placebo- and sham-controlled study. All patients received antiemetic prophylaxis with metoclopramide, 10 mg intravenously, or droperidol, 0.625 mg intravenously, after induction of anesthesia. A total of 90 patients developed PONV in the recovery units and were randomized to one of three treatment groups: (1) the ondansetron group received 4 mg intravenous ondansetron and a sham ReliefBand; (2) the acustimulation group received 2 ml intravenous saline and a ReliefBand; and (3) the combination group received 4 mg intravenous ondansetron and a ReliefBand. A rescue antiemetic (10 mg intravenous metoclopramide) was administered only if the PONV symptoms persisted for 15 min or longer after initiating the treatment. A blinded observer recorded the recovery times, emetic symptoms, rescue antiemetics, maximum nausea scores, complete response to study treatment, and time to achieve discharge criteria. Postdischarge side effects, as well as patient satisfaction and quality of recovery scores, were assessed at 24 and 72 h after surgery. RESULTS: The combination group had a significantly higher complete response rate than the acustimulation group (73% vs.40%, P <0.01). In addition, fewer patients (8 vs. 18) in the combination (vs. acustimulation) group experienced subsequent emetic events (P < 0.03). However, there were no significant differences between the three groups with respect to patient satisfaction and quality of recovery scores. CONCLUSIONS: Acustimulation with the ReliefBand can be used as an alternative to ondansetron for the treatment of established PONV. However, the use of ondansetron (4 mg intravenously) in combination with the ReliefBand device improved the complete response rate to the acustimulation therapy.
RCT Entities:
BACKGROUND: This study was designed to evaluate transcutaneous electrical acupoint stimulation (acustimulation) using the ReliefBand compared with ondansetron for the treatment of established postoperative nausea and vomiting (PONV) after outpatient laparoscopic surgery. METHODS: After the authors obtained institutional review board approval and written informed consent, 268 outpatients were enrolled in this randomized, double-blind, placebo- and sham-controlled study. All patients received antiemetic prophylaxis with metoclopramide, 10 mg intravenously, or droperidol, 0.625 mg intravenously, after induction of anesthesia. A total of 90 patients developed PONV in the recovery units and were randomized to one of three treatment groups: (1) the ondansetron group received 4 mg intravenous ondansetron and a sham ReliefBand; (2) the acustimulation group received 2 ml intravenous saline and a ReliefBand; and (3) the combination group received 4 mg intravenous ondansetron and a ReliefBand. A rescue antiemetic (10 mg intravenous metoclopramide) was administered only if the PONV symptoms persisted for 15 min or longer after initiating the treatment. A blinded observer recorded the recovery times, emetic symptoms, rescue antiemetics, maximum nausea scores, complete response to study treatment, and time to achieve discharge criteria. Postdischarge side effects, as well as patient satisfaction and quality of recovery scores, were assessed at 24 and 72 h after surgery. RESULTS: The combination group had a significantly higher complete response rate than the acustimulation group (73% vs.40%, P <0.01). In addition, fewer patients (8 vs. 18) in the combination (vs. acustimulation) group experienced subsequent emetic events (P < 0.03). However, there were no significant differences between the three groups with respect to patient satisfaction and quality of recovery scores. CONCLUSIONS: Acustimulation with the ReliefBand can be used as an alternative to ondansetron for the treatment of established PONV. However, the use of ondansetron (4 mg intravenously) in combination with the ReliefBand device improved the complete response rate to the acustimulation therapy.