In this prospective, double-blind, randomized, controlled trial, we studied 200 patients undergoing a laparoscopic cholecystectomy during propofol (induction) fentanyl/isoflurane/atracurium (maintenance) anaesthesia.
Premedication was carried out with midazolam 7.5 mg orally on the day of surgery. General anaesthesia was induced with propofol (1-2 mg/kg i.v.), fentanyl (1 ug/kg i.v.), and atracurium (0.5 mg/kg i.v.), and was maintained by isoflurane 0.8-1.6% endtidal in nitrous oxide (60-70%) at the discretion of the anaesthesiologist not involved in the study. All patients received 0.1mg/kg morphine i.v. during surgery 30 min before the end of the operation. Analgetic therapy with morphine was continued in the post-anaesthetic care unit (PACU). A rescue therapy of 2 mg tropisetron was administered to any patient who experienced an episode of moderate or severe nausea, an episode of vomiting, or who requested rescue medication.
Stimulation Method
EA
Induction Method
Electroacupuncture Instrument Model
Manufacturer
Frequency
Waveform
Strength
Induction Time
ReliefBands
Woodside Bio-medical Systems, Carlsbad, CA, USA
31 Hz
-
grade III. (up to 35 mA gradable in five strengths)
before induction or directly after induction of anaesthesia and remained in situ and active for 24 h after surgery.
Acupuncture_Needle
Needle_Manufacturer
Needle_Depth
-
-
-
Description The ReliefBands were activated (31 Hz, strength grade III) either before induction or directly after induction of anaesthesia depending on patients' group assignment and remained in situ and active for 24 h after surgery.
Anesthesia Method
AAA
Clinical Trial Type
random
Contraindications
Ex_x005fclusion criteria were patients with a cardiac pacemaker or implanted cardioverter/defibrillator,patients at risk for malignant hyperthermia, patients with an allergy to nickel/chrome, and change in surgical technique
Effector
The incidence of early nausea (up to 2 h) was significantly lower in the acustimulation than in the sham group (29% vs. 42%; P=0.043). No significant effect could be detected for retching/vomiting. Moreover, acustimulation showed no effect on PONV after 6 and 24 h. Risk factor analysis (female gender, non-smoker, history of PONV/motion sickness, and post-operative morphine usage) revealed a relative reduction in risk of 40% for nausea (P=0.021) and 55% for retching/vomiting (P=0.048) in patients with three or four risk factors present. The timing of (pre- vs. post-induction) acustimulation had no significant effect on PONV reduction. Acustimulation at the P6 acupoint reduces early nausea, but not vomiting, after laparoscopic cholecystectomy, irrespective of its pre- or post-induction application.
Effect of P6 acustimulation on post-operative nausea and vomiting in patients undergoing a laparoscopic cholecystectomy.
Abstract
BACKGROUND: Non-pharmacologic techniques such as electrical acustimulation may mitigate post-operative nausea and vomiting (PONV). The primary purpose of this study was to investigate the effectiveness of acustimulation on attenuating PONV. Moreover, we tested whether a pre- or a post-induction application of acustimulation results in differences in PONV reduction. METHODS: In this prospective, double-blind, randomized, controlled trial, we studied 200 patients undergoing a laparoscopic cholecystectomy during propofol (induction) fentanyl/isoflurane/atracurium (maintenance) anaesthesia. In the acustimulation group (n=101), subdivided into groups with pre-induction (n=57) and post-induction (n=44) acustimulation, an active ReliefBand device was placed at the P6 acupoint. In the sham group (n=99), also subdivided into pre-induction (n=55) or post-induction (n=44) groups, an inactive device was applied instead. The ReliefBand remained in place for 24 h after surgery. Nausea and vomiting/retching were recorded at 2, 6, and 24 h post-operatively. RESULTS: The incidence of early nausea (up to 2 h) was significantly lower in the acustimulation than in the sham group (29% vs. 42%; P=0.043). No significant effect could be detected for retching/vomiting. Moreover, acustimulation showed no effect on PONV after 6 and 24 h. Risk factor analysis (female gender, non-smoker, history of PONV/motion sickness, and post-operative morphine usage) revealed a relative reduction in risk of 40% for nausea (P=0.021) and 55% for retching/vomiting (P=0.048) in patients with three or four risk factors present. The timing of (pre- vs. post-induction) acustimulation had no significant effect on PONV reduction. CONCLUSION: Acustimulation at the P6 acupoint reduces early nausea, but not vomiting, after laparoscopic cholecystectomy, irrespective of its pre- or post-induction application."
