Bhatnagar 2007.

Study characteristics
Methods	Study design: randomized controlled trial Study grouping: 3 groups, monoprophylaxis
Participants	Baseline characteristics Placebo Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 30 Received treatment (n): NA Analysed (n): 30 Age (mean ± SD, median (IQR), median (range)): 45 ± 12 Weight (mean ± SD, median (IQR), median (range)): 58 ± 10 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): 13.33/10 Type of general anaesthesia: inhalational anaesthesia (isoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 142 Use of perioperative opioids (if yes, which?): fentanyl 2 µg/kg for induction, 10 patients with postoperative tramadol 100 mg, 1 patient with morphine 3 mg within 2 hours Type of surgery: modified radical mastectomy Granisetron Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 30 Received treatment (n): NA Analysed (n): 30 Age (mean ± SD, median (IQR), median (range)): 48 ± 10 Weight (mean ± SD, median (IQR), median (range)): 60 ± 10 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): 16.67/13.33 Type of general anaesthesia: inhalational anaesthesia (isoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 142 Use of perioperative opioids (if yes, which?): fentanyl 2 µg/kg for induction, 10 patients with postoperative tramadol 100 mg, no patients with morphine 3 mg within 2 hours Type of surgery: modified radical mastectomy Ondansetron Assessed for eligibility (n): ‐ Enrolled (n): ‐ Randomized (n): 30 Received treatment (n): NA Analysed (n): 30 Age (mean ± SD, median (IQR), median (range)): 50 ± 12 Weight (mean ± SD, median (IQR), median (range)): 56 ± 12 BMI (mean ± SD, median (IQR), median (range)): NA ASA I/II/III/IV (n): NA/NA/0/0 Gender (female in %): 100 Non‐smoker (%): NA History of PONV/motion sickness (%): 16.67/13.33 Type of general anaesthesia: inhalational anaesthesia (isoflurane, N₂O) Duration of anaesthesia or surgery (in min; as mean or median): 141 Use of perioperative opioids (if yes, which?): fentanyl 2 µg/kg for induction, 9 patients with postoperative tramadol 100 mg, no patients with morphine 3 mg within 2 hours Type of surgery: modified radical mastectomy Included criteria: ASA physical status I and II, hospitalised female patients, 18 to 65 years of age, scheduled for modified radical mastectomy Excluded criteria: patients with gastrointestinal (GI) disease (e.g. hiatal hernia, gastro‐oesophageal regurgitation disorder, non‐ulcerative dyspepsia, peptic ulcer disease, and autonomic dysfunction disorder); those who were menstruating; those who had received any antiemetic medication within 24 hours of surgery Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear
Interventions	Intervention characteristics Placebo Dose: placebo Time point of administration: 1 hour before induction of anaesthesia Route of administration: PO Rescue antiemetics (if yes, which?): ondansetron 4 mg IV Granisetron Dose: 2 mg Time point of administration: 1 hour before induction of anaesthesia Route of administration: PO Rescue antiemetics (if yes, which?): ondansetron 4 mg IV Ondansetron Dose: 4 mg Time point of administration: 1 hour before induction of anaesthesia Route of administration: PO Rescue antiemetics (if yes, which?): ondansetron 4 mg IV
Outcomes	Vomiting (0 to 2 hours) Outcome type: dichotomous outcome Vomiting (2 to 6 hours) Outcome type: dichotomous outcome Subjects with any AE (0 to 2, 2 to 6, 6 to 12, 12 to 24 hours) Outcome type: dichotomous outcome Headache (0 to 2, 2 to 6, 6 to 12, 12 to 24 hours) Outcome type: dichotomous outcome Sedation/drowsiness (0 to 2, 2 to 6, 6 to 12, 12 to 24 hours) Outcome type: dichotomous outcome Adverse events (general notes in the publication, 24 hours' observation) Outcome type: general notes on side effects
Identification	Sponsorship source: NA Country: India Setting: inpatient, single‐centre Author's name: Sushma Bhatnagar Institution: Department of Anesthesiology, Institute Rotary Cancer Hospital (IRCH), All India Institute of Medical Sciences (AIIMS) Email: shumob@yahoo.com Address: Department of Anesthesiology, Institute Rotary Cancer Hospital (IRCH), All India Institute of Medical Sciences (AIIMS), Ansari Nagar, New Delhi 110029, India Duration of study: NA Language: English Study's primary outcome: complete response Trial registry number: NA
Notes	None
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "generated by a random number function in a computer spreadsheet"
Allocation concealment (selection bias)	Unclear risk	Judgement comment: no statement
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "patients and data collectors were both blinded to treatment" Quote: "all three study drugs were provided as identical, blue, cylindrical capsules and administered according to a randomization list"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "patients and data collectors were both blinded to treatment"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "no patient was withdrawn from the study" Judgement comment: no missing outcome data
Selective reporting (reporting bias)	Unclear risk	Judgement comment: no reference to a study protocol or trial registry number reported
Other bias	Unclear risk	Quote: "in our study, the groups were similar with respect to age, weight, preoperative chemotherapy, history of motion sickness or previous PONV, last menstrual period, duration of anesthesia and surgery, and postoperative analgesia" Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear