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

Perez Ascencio 1992.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 4 groups, monoprophylaxis
Participants Baseline characteristics
Droperidol
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 15

  • Received treatment (n): NA

  • Analysed (n): 15

  • Age (mean ± SD, median (IQR), median (range)): 28 ± 7

  • Weight (mean ± SD, median (IQR), median (range)): 58 ± 6

  • 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 (%): 0/NA

  • Type of general anaesthesia: balanced general anaesthesia (enflurane, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): 207

  • Use of perioperative opioids (if yes, which?): 359 µg fentanyl intraoperative

  • Type of surgery: head and neck surgery


Diphenidol
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 15

  • Received treatment (n): NA

  • Analysed (n): 15

  • Age (mean ± SD, median (IQR), median (range)): 27 ± 9

  • Weight (mean ± SD, median (IQR), median (range)): 59 ± 7

  • 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 (%): 0/NA

  • Type of general anaesthesia: balanced general anaesthesia (enflurane, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): 192

  • Use of perioperative opioids (if yes, which?): 303 µg fentanyl intraoperative

  • Type of surgery: head and neck surgery


Metoclopramide
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 15

  • Received treatment (n): NA

  • Analysed (n): 15

  • Age (mean ± SD, median (IQR), median (range)): 29 ± 14

  • Weight (mean ± SD, median (IQR), median (range)): 62 ± 10

  • 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 (%): 0/NA

  • Type of general anaesthesia: balanced general anaesthesia (enflurane, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): 249

  • Use of perioperative opioids (if yes, which?): 456 µg fentanyl intraoperative

  • Type of surgery: head and neck surgery


Placebo
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 15

  • Received treatment (n): NA

  • Analysed (n): 15

  • Age (mean ± SD, median (IQR), median (range)): 30 ± 11

  • Weight (mean ± SD, median (IQR), median (range)): 61 ± 8

  • 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 (%): 0/NA

  • Type of general anaesthesia: balanced general anaesthesia (enflurane, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): 155

  • Use of perioperative opioids (if yes, which?): 340 µg fentanyl intraoperative

  • Type of surgery: head and neck surgery


Included criteria: both sexes, 18 to 60 years of age, scheduled for elective surgery of the head and neck (maxillofacial surgery, plastic surgery, reconstructive surgery), ASA I or II
Excluded criteria: old history of nausea and postoperative vomiting, obese, women, pregnant or in the menstrual period, pathology leading to vomiting
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (history of PONV): no; (gender, non‐smoker, history of motion sickness): unclear; (perioperative opioids, duration of anaesthesia): yes
Interventions Intervention characteristics
Droperidol
  • Dose: 15 µg/kg to 20 µg/kg

  • Time point of administration: 30 minutes before end of anaesthetic procedure

  • Route of administration: IV

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


Diphenidol
  • Dose: 150 µg/kg

  • Time point of administration: 30 minutes before end of anaesthetic procedure

  • Route of administration: IV

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


Metoclopramide
  • Dose: 150 µg/kg

  • Time point of administration: 30 minutes before end of anaesthetic procedure

  • Route of administration: IV

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


Placebo
  • Dose: 3 ml saline

  • Time point of administration: 30 minutes before end of anaesthetic procedure

  • Route of administration: IV

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

Outcomes Vomiting (0 to 4 hours)
  • Outcome type: dichotomous outcome

Identification Sponsorship source: NA
Country: Mexico
Setting: inpatient, single‐centre
Author's name: Rebeca E. Pérez‐Ascencio
Institution: Departemento de Anestesiología del Hospital de Escpecialidades del Centro Médico La Raza
Email: NA
Address: Departemento de Anestesiología del Hospital de Escpecialidades del Centro Médico La Raza, Instituto Mexicano del Seguro social (IMSS), México D.F.
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: "a random population of 60 patients ..." (translated)
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: no statement on blinding of participants and personnel
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: no statement on blinding of outcome assessor
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 High risk Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (history of PONV): no; (gender, non‐smoker, history of motion sickness): unclear; (perioperative opioids, duration of anaesthesia): yes