We studied 221 outpatients undergoing laparoscopic cholecystectomy with a standardized general anesthetic technique in this randomized, multicenter trial.
Sample Count
221
Age
＞18
Control
Sham
Placebo
Sham(n=56);Placebo(n=55)
Experiment
TAES(n=110)
Indicator
Postoperative Nausea and Vomiting(PONV)Need for rescue medicationAntiemetic dosageDurations of surgeryDuration of anesthesiaThe length of recovery room stayDuration of hospital stay
Auxiliary Medication
Midazolam 20-30 ug/kg IV was administered for premedication, and anesthesia was induced with fen- tanyl 1-3 ug/kg IV and propofol, 1.5-2.5 mg/kg IV. Maintenance of anesthesia consisted of isoflurane 0.6%-1.8% (inspired concentration) in combination with nitrous oxide 50%-70% in oxygen. Supplemental bolus doses of fentanyl 0.5 ug/kg IV were administered, if needed, to treat persistent tachycardia caused by inadequate intraoperative analgesia. An oral gastric tube was inserted after tracheal intubation and removed at the end of surgery. Residual neuromuscular blockade was antagonized with neostigmine 40-60 ug/kg IV and glycopyrrolate 6-12 ug/kg IV. No pro-phylactic antiemetic medication was administered during the perioperative period.
Stimulation Method
TEAS
Induction Method
Electroacupuncture Instrument Model
Manufacturer
Frequency
Waveform
Strength
Induction Time
-
Woodside Biomedical, Inc, Carls-bad, CA
31 Hz
-
25 mA
-
Acupuncture_Needle
Needle_Manufacturer
Needle_Depth
-
-
-
Description For the purpose of this study, the device was set to deliver a 25 mA (setting 1) stimulus at 31 Hz.
Anesthesia Method
GA
Clinical Trial Type
random
Adverse Effects
The only side effect noted in this study was mild cutaneous irritation with erythema in two patients,which resolved spontaneously within 24 h after re_x005fmoving the ReliefBand.
Contraindications
Patients who were pregnant; had an implanted cardiac pacemaker or defibrillator device excluded
Effector
TAES was associated with a significantly decreased incidence of moderate-to-severe nausea as denoted on the Functional Living Index—Emesis score for up to 9 h after surgery (5%–11% for the TAES group vs 16%–38% [P<0.05] and 15%–26% [P<0.05] for Sham and Placebo groups, respectively). TAES was also associated with a larger proportion of patients free from moderate to severe nausea symptoms (73% vs 41% and 49% for Sham and Placebo groups, respectively;P< 0.05). However, there were no statistically significant differences among the three groups with regard to incidence of vomiting or the need for rescue antiemetic drugs. We conclude that TAES with the ReliefBand at the P6 acupoint reduces nausea, but not vomiting, after laparoscopic cholecystectomy.
The use of transcutaneous acupoint electrical stimulation for preventing nausea and vomiting after laparoscopic surgery.
Abstract
Nonpharmacologic techniques may be effective in preventing postoperative nausea and vomiting (PONV). This sham-controlled, double-blinded study was designed to examine the antiemetic efficacy of transcutaneous acupoint electrical stimulation (TAES) in a surgical population at high risk of developing PONV. We studied 221 outpatients undergoing laparoscopic cholecystectomy with a standardized general anesthetic technique in this randomized, multicenter trial. In the TAES group, an active ReliefBand(Woodside Biomedical, Inc., Carlsbad, CA) device was placed at the P6 acupoint, whereas in the Sham and Placebo groups, an inactive device was applied at the P6 acupoint and at the dorsal aspect of the wrist, respectively. The ReliefBand was applied after completion of electrocautery and remained in place for 9 h after surgery. The incidence of PONV and need for ""rescue"" medication were evaluated at predetermined time intervals. TAES was associated with a significantly decreased incidence of moderate-to-severe nausea as denoted on the Functional Living Index-Emesis score for up to 9 h after surgery (5%-11% for the TAES group vs 16%-38% [P < 0.05] and 15%-26% [P < 0.05] for Sham and Placebo groups, respectively). TAES was also associated with a larger proportion of patients free from moderate to severe nausea symptoms (73% vs 41% and 49% for Sham and Placebo groups, respectively; P < 0.05). However, there were no statistically significant differences among the three groups with regard to incidence of vomiting or the need for rescue antiemetic drugs. We conclude that TAES with the ReliefBand at the P6 acupoint reduces nausea, but not vomiting, after laparoscopic cholecystectomy. IMPLICATIONS: Transcutaneous acupoint electrical stimulation at the P6 acupoint reduced postoperative nausea, but not vomiting, in outpatients undergoing laparoscopic cholecystectomy procedures."
