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. 2020 Oct 19;2020(10):CD012859. doi: 10.1002/14651858.CD012859.pub2

Sadhasivam 1999.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 2 groups, monoprophylaxis
Participants Baseline characteristics
Placebo
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 27

  • Received treatment (n): 27

  • Analysed (n): 27

  • Age (mean ± SD, median (IQR), median (range)): 46.5 ± 11.2

  • Weight (mean ± SD, median (IQR), median (range)): 54.7 ± 10.7

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): 19/8/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 3.70/18.52

  • Type of general anaesthesia: inhalational anaesthesia (N2O, isoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 147.3

  • Use of perioperative opioids (if yes, which?): 59.1 mg meperidine

  • Type of surgery: modified radical mastectomy


Ondansetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 27

  • Received treatment (n): 27

  • Analysed (n): 27

  • Age (mean ± SD, median (IQR), median (range)): 44.9 ± 11.1

  • Weight (mean ± SD, median (IQR), median (range)): 56.9 ± 8.9

  • BMI (mean ± SD, median (IQR), median (range)): NA

  • ASA I/II/III/IV (n): 21/6/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 7.41/18.52

  • Type of general anaesthesia: inhalational anaesthesia (N2O, isoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 157.8

  • Use of perioperative opioids (if yes, which?): 58.9 mg meperidine

  • Type of surgery: modified radical mastectomy


Included criteria: ASA I or II, adult female patients undergoing modified radical mastectomy for carcinoma of the breast
Excluded criteria: morbid obesity, gastrointestinal disease with gastric outlet obstruction, had received drugs with an antiemetic effect within 24 hours before anaesthesia
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: saline

  • Time point of administration: at end of surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 59% (150 µg/kg metoclopramide IV, ondansetron 4 mg IV)


Ondansetron
  • Dose: 4 mg

  • Time point of administration: at end of surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 15% (150 µg/kg metoclopramide IV, ondansetron 4 mg IV)

Outcomes Vomiting (0 to 24 hours)
  • Outcome type: dichotomous outcome


PONV (0 to 24 hours)
  • Outcome type: dichotomous outcome


Headache (0 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: Abha Saxena
Institution: Department of Anesthesiology, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India
Email: saxenas@medinst.ernet.in
Address: Department of Anesthesiology, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India
Duration of study: NA
Language: English
Study's primary outcome: NA
Trial registry number: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "patients were allocated to receive, in a randomized, double‐blinded manner, a single dose of either ondansetron 4 mg (4 mL) IV or saline at an equal volume (4 mL) as a placebo at the end of the surgery"
Judgement comment: no information on sequence generation provided
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Quote: "patients were allocated to receive, in a randomized, double‐blinded manner, a single dose of either ondansetron 4 mg (4 mL) IV or saline at an equal volume (4 mL) as a placebo at the end of the surgery"
Judgement comment: insufficient information on blinding
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: insufficient information on blinding ("double‐blinded manner")
Incomplete outcome data (attrition bias)
All outcomes Low risk 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: "there were no significant differences between the groups with regard to age, weight, ASA physical status, duration of anesthesia, and intraoperative and postoperative analgesic requirements (Table 1)"
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