Sharma 2007.
Methods | Parallel‐group randomized trial, conducted in India. Study dates not reported. | |
Participants | 60 women undergoing laparoscopic cholecystectomies under general anaesthesia. Exclusion: obesity, previous history of PONV and motion sickness. | |
Interventions | Group 1: ondansetron 4 mg IV given 10 min after induction of anaesthesia (n = 20). Group 2: bilateral P6 acupuncture 5 min before induction of anaesthesia. Intermittent stimulation was given at P6 acupoints by rotating needle clockwise and anticlockwise up to 30 min (n = 20). Group 3: combination of group 1 and group 2 interventions (n = 20). |
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Outcomes | Nausea (0 ‐ 7 h), vomiting (0 ‐ 7 h), risk of rescue antiemetic drug (0 ‐ 7 h), risk of adverse effects. | |
Notes | Rescue antiemetic was metoclopramide 10 mg IV. No pain, bleeding, vasovagal attack, or broken acupuncture needles noted in any of the groups. No details about funding source or any declarations of interest among authors. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information. |
Allocation concealment (selection bias) | Unclear risk | Insufficient information. |
Blinding of patients (performance bias) All outcomes | High risk | "Blinding of any form was not possible because acupuncture needles had to be kept in situ in the operating room". |
Blinding of healthcare providers (performance bias) All outcomes | High risk | "Blinding of any form was not possible because acupuncture needles had to be kept in situ in the operating room". |
Blinding of outcome assessor (detection bias) All outcomes | High risk | "Blinding of any form was not possible because acupuncture needles had to be kept in situ in the operating room". |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data reported for 60 women analysed. |
Selective reporting (reporting bias) | Low risk | All expected outcomes reported. |
Other bias | Low risk | Baseline characteristics were comparable. "There was no significant difference among the patients in both the groups regarding weight, age, height, gender, hours of preoperative fasting and duration of anesthesia and surgery...". |