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

Perez Garcia 2000.

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

  • Enrolled (n): ‐

  • Randomized (n): 50

  • Received treatment (n): NA

  • Analysed (n): 50

  • 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/NA/0

  • Gender (female in %): NA

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: inhalational anaesthesia (isoflurane, halothane, enflurane)

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

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

  • Type of surgery: elective surgery (general surgery, gynaecological, ophthalmological, maxillofacial, other)


Metoclopramide
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 50

  • Received treatment (n): NA

  • Analysed (n): 50

  • 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/NA/0

  • Gender (female in %): NA

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: inhalational anaesthesia (isoflurane, halothane, enflurane)

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

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

  • Type of surgery: elective surgery (general surgery, gynaecological, ophthalmological, maxillofacial, other)


Included criteria: adult; ASA I, II, or III; scheduled for elective surgery under general anaesthesia with endotracheal intubation and administration of narcotic analgesic fentanyl
Excluded criteria: received an antiemetic within 24 hours before surgery; with antecedents of nausea and/or vomiting due to kidney disease, liver disease, peptic acid, and stomach surgery; those who in the postoperative period received a prophylactic antiemetic treatment equal to or different from the drugs studied
Pretreatment: baseline characteristics (age, weight, ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): unclear
Interventions Intervention characteristics
Ondansetron
  • Dose: 4 mg

  • Time point of administration: before induction of anaesthesia

  • Route of administration: IV

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


Metoclopramide
  • Dose: 10 mg

  • Time point of administration: before induction of anaesthesia

  • Route of administration: IV

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

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


Vomiting (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: Mexiko
Setting: inpatient, single‐centre
Author's name: Austreberto Pérez Garcia
Institution: Departemento de Anestesiologia, Hospital General de Zona 1 del IMSS, Tapachula Chiapas
Email: austreberto@acnet.net
Address: Andador Cafetales Manzaneros 1 Casa 3 Fracc. Santa Clara, Tapachula Chiapas CP 30788
Duration of study: NA
Language: Spanish (translated by Insa Backhaus)
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 Judgement comment: quote: "..prospective, randomized, triple‐blind..."
No further 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: quote: "..prospective, randomized, triple‐blind..."
Insufficient information on blinding
Blinding of outcome assessment (detection bias)
All outcomes Low risk Judgement comment: quote: "the evaluator did not know which medication had been administered"
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Judgement comment: no reasons for exclusion described for 3 participants
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, weight, ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): unclear