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

Dobkin 1968.

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): 94

  • Received treatment (n): NA

  • Analysed (n): 94

  • 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

  • Gender (female in %): 50

  • Non‐smoker (%): NA

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

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

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

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

  • Type of surgery: major upper abdominal operations


Metoclopramide
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 96

  • Received treatment (n): NA

  • Analysed (n): 96

  • 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

  • Gender (female in %): 62.5

  • Non‐smoker (%): NA

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

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

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

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

  • Type of surgery: major upper abdominal operations


Trimethobenzamide
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 94

  • Received treatment (n): NA

  • Analysed (n): 94

  • 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

  • Gender (female in %): 55.32

  • Non‐smoker (%): NA

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

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

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

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

  • Type of surgery: major upper abdominal operations


Included criteria: adult patients, elective cases scheduled for major upper abdominal operations
Excluded criteria: NA
Pretreatment: baseline characteristics (age): no; (weight, ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear
Interventions Intervention characteristics
Placebo
  • Dose: lactose

  • Time point of administration: approximately 30 minutes before end of each operation

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): NA


Metoclopramide
  • Dose: 20 mg

  • Time point of administration: approximately 30 minutes before end of each operation

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): NA


Trimethobenzamide
  • Dose: 300 mg

  • Time point of administration: approximately 30 minutes before end of each operation

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): NA

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

Identification Sponsorship source: this project was supported by a grant‐in‐aid from Merck Sharp Dohme Research Laboratories
Country: USA
Setting: inpatient, single‐centre
Author's name: Allen B. Dobkin
Institution: Department of Anesthesiology, State University Hospital, State University of New York, Upstate Medical Center, Syracuse, New York, NY, USA
Email: NA
Address: NA
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) Low risk Quote: "the order of assignment of the drugs followed a random number code"
Allocation concealment (selection bias) Unclear risk Quote: "the order of assignment of the drugs followed a random number code. The identity of the substance was not known to the anaesthetist, who merely recorded the code number of the drug on his anaesthetic record after he administered the material"
Judgement comment: no details on allocation provided
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "the identity of the substance was not known to the anaesthetist"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "the patient's chart was reviewed 24 hours postoperatively to record the incidence of nausea and vomiting and related information. The identity of the compounds administered was not revealed to the principals involved in the study until the study was completed and all the data were tabulated"
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "each patient's record was reviewed 24 hours after the operation to obtain follow‐up data"
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 (age): no; (weight, ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear