77 consecutive patients undergoing major breast surgery who met inclusion criteria were randomized into three groups: active electro-acupoint stimulation (A), ondansetron 4 mg IV (O), and sham control (placement of electrodes without electro-acupoint stimulation; placebo [P]).
Sample Count
77
Control
Sham
sham control (placement of electrodes without electro-acupoint stimulation
Experiment
active electro-acupoint stimulation (A)(n=26); placebo (P)(n=24); ondansetron 4 mg IV (O)(n=25)
Indicator
Postoperative Nausea and Vomiting(PONV)Rescue antiemetic usePainPatient satisfaction
Auxiliary Medication
All patients received fentanyl 100 ug IV and midazolam 2 mg IV premedication in the preoperative holding area before going into the operating room. Study drugs were prepared by the pharmacists not directly involved in the study and consisted of either ondansetron 4 mg (2 mL) or an equivalent volume of saline (for the A and P groups), and were administered to the subjects at induction of anesthesia.
The intraoperative anesthetic regimen was standardized. Induction of anesthesia was achieved with propofol 1.5-2 mg/kg and tracheal tube placement was aided by succinylcholine 1 mg/kg or rocuronium 0.6 mg/kg. Isoflurane at 0.5%-1.5%, nitrous oxide 50% in oxygen, and supplemental fentanyl up to 4 g · kg-1 · h-1 were used to maintain anesthesia and hemodynamics (heart rate and arterial blood pressure) within 20% of baseline. Patients’ neuromuscular blockade was antagonized by neostigmine 0.07 mg/kg and glycopyrrolate 0.01 ug/kg.
Stimulation Method
EA
Induction Method
Electroacupuncture Instrument Model
Manufacturer
Frequency
Waveform
Strength
Induction Time
HANS electrodes;HANS dual channel unit
Beijing Huawei Co, Ltd., Beijing, China
2-100 Hz
alternating wave
-
30-60 min
Acupuncture_Needle
Needle_Manufacturer
Needle_Depth
-
-
-
Description The stimulation unit was set on 2–100 Hz alternating waveform.
Anesthesia Method
AAA
Clinical Trial Type
random
Adverse Effects
there was no residual redness on the acupuncture site in any groups.
Contraindications
Patients who were pregnant, were experiencing menstrual symptoms, were using a permanent cardiac pace_x005fmaker, had previous experience with acupuncture therapies, had received any antiemetic medication or had experienced nausea, vomiting, or retching within 24 h of surgery were excluded
Effector
The complete response (no nausea, vomiting, or use of rescue antiemetic) was significantly more frequent in the active treatment groups compared with placebo both at 2 h (A/O/P = 77%/64%/42%, respectively; P = 0.01) and 24 h postoperatively (A/O/P = 73%/52%/38%, respectively; P = 0.006). The need for rescue antiemetic was less in the treatment groups (A/O/P = 19%/28%/54%; P = 0.04). Specifically, the incidence and severity of nausea were significantly less in the A group compared with the other groups, and in the O group compared with the P group (A/O/P = 19%/40%/79%, respectively). The A group experienced less pain in the postanesthesia care unit, compared with the O and P groups. Patients in the treatment groups were more satisfied with their management of PONV compared with placebo. When used for the prevention of PONV, electro-acupoint stimulation or ondansetron was more effective than placebo with greater degree of patient satisfaction, but electro-acupoint stimulation seems to be more effective in controlling nausea, compared with ondansetron. Stimulation at P6 also has analgesic effects.
A randomized controlled comparison of electro-acupoint stimulation or ondansetron versus placebo for the prevention of postoperative nausea and vomiting.
Abstract
In this study we evaluated the efficacy of electro-acupoint stimulation, ondansetron versus placebo for the prevention of postoperative nausea and vomiting (PONV). Patients undergoing major breast surgery under general anesthesia were randomized into active electro-acupoint stimulation (A), ondansetron 4 mg IV (O), or sham control (placement of electrodes without electro-acupoint stimulation; placebo [P]). The anesthetic regimen was standardized. The incidence of nausea, vomiting, rescue antiemetic use, pain, and patient satisfaction with management of PONV were assessed at 0, 30, 60, 90, 120 min, and at 24 h. The complete response (no nausea, vomiting, or use of rescue antiemetic) was significantly more frequent in the active treatment groups compared with placebo both at 2 h (A/O/P = 77%/64%/42%, respectively; P = 0.01) and 24 h postoperatively (A/O/P = 73%/52%/38%, respectively; P = 0.006). The need for rescue antiemetic was less in the treatment groups (A/O/P = 19%/28%/54%; P = 0.04). Specifically, the incidence and severity of nausea were significantly less in the A group compared with the other groups, and in the O group compared with the P group (A/O/P = 19%/40%/79%, respectively). The A group experienced less pain in the postanesthesia care unit, compared with the O and P groups. Patients in the treatment groups were more satisfied with their management of PONV compared with placebo. When used for the prevention of PONV, electro-acupoint stimulation or ondansetron was more effective than placebo with greater degree of patient satisfaction, but electro-acupoint stimulation seems to be more effective in controlling nausea, compared with ondansetron. Stimulation at P6 also has analgesic effects."
