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

Muhammad 2000.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis
Participants Baseline characteristics
Tropisetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 16

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

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

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): NA

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): NA

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

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

  • Use of perioperative opioids (if yes, which?): NA

  • Type of surgery: mini‐laparotomy cholecystectomy


Metoclopramide
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 16

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

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

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): NA

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): NA

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

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

  • Use of perioperative opioids (if yes, which?): NA

  • Type of surgery: mini‐laparotomy cholecystectomy


Placebo
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 18

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

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

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): NA

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): NA

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

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

  • Use of perioperative opioids (if yes, which?): NA

  • Type of surgery: mini‐laparotomy cholecystectomy


Included criteria: few or no other risk factors for anaesthesia, ASA I and II, between 22 and 71 years of age with cholelithiasis but no obvious bile duct pathology, had mini‐laparotomy cholecystectomy
Excluded criteria: NA
Pretreatment: baseline characteristics (ASA): no; (age, weight): unclear. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): unclear
Interventions Intervention characteristics
Tropisetron
  • Dose: 2 mg

  • Time point of administration: immediately after induction

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 10 mg


Metoclopramide
  • Dose: 10 mg

  • Time point of administration: immediately after induction

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 10 mg


Placebo
  • Dose: saline

  • Time point of administration: immediately after induction

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 10 mg

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

Identification Sponsorship source: NA
Country: Pakistan
Setting: inpatient, single‐centre
Author's name: Syed Razi Muhammad
Institution: Department of Surgery, Baqai Medical University, Karachi
Email: NA
Address: 51, Deh Tor, Gadap Road, Near Toll Plaza, Super Highway P.O Box No 2407, Karachi ‐ 74600, Pakistan
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: "all patients were randomised to receive immediately after induction one of the following three: Injection Tropisteron 2mg"
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 Judgement comment: no statement
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: no statement
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 Judgement comment: baseline characteristics (ASA): no; (age, weight): unclear. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): unclear