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

Steinbrook 1998.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis and combination prophylaxis
Participants Baseline characteristics
Ondansetron + droperidol
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 66

  • Age (mean ± SD, median (IQR), median (range)): 44 ± 13

  • Weight (mean ± SD, median (IQR), median (range)): 74 ± 17

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 81.8

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 67

  • Use of perioperative opioids (if yes, which?): 225 µg fentanyl intraoperative, 55 patients received opioids in PACU

  • Type of surgery: laparoscopic cholecystectomy


Droperidol + metoclopramide
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 66

  • Age (mean ± SD, median (IQR), median (range)): 44 ± 14

  • Weight (mean ± SD, median (IQR), median (range)): 77 ± 15

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 81.8

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 68

  • Use of perioperative opioids (if yes, which?): 244 µg fentanyl intraoperative, 54 patients received opioids in PACU

  • Type of surgery: laparoscopic cholecystectomy


Perphenazine
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 68

  • Age (mean +/‐ SD, median (IQR), median [range]): 46 +/‐ 13

  • Weight (mean +/‐ SD, median (IQR), median [range]): 74 +/‐ 16

  • BMI (mean +/‐ SD, median (IQR), median [range]): NA

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 77.9

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 68

  • Use of perioperative opioids (if yes, which?): 230 µg fentanyl intraoperative, 51 patients received opioids in PACU

  • Type of surgery: laparoscopic cholecystectomy


Included criteria: scheduled for laparoscopic cholecystectomy
Excluded criteria: NA
Pretreatment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear
Interventions Intervention characteristics
Ondansetron + droperidol
  • Dose: ondansetron 4 mg, droperidol 0.625 mg

  • Time point of administration: immediately after tracheal intubation

  • Route of administration: IV

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


Droperidol + metoclopramide
  • Dose: droperidol 0.625 mg, metoclopramide 10 mg

  • Time point of administration: immediately after tracheal intubation

  • Route of administration: IV

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


Perphenazine
  • Dose: perphenazine 5 mg, placebo 50 ml saline

  • Time point of administration: immediately after tracheal intubation

  • Route of administration: IV

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

Outcomes Vomiting (0 to 2 hours)
  • Outcome type: dichotomous outcome


Vomiting (2 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: USA
Setting: inpatient, single‐centre
Author's name: Richard A. Steinbrook
Institution: Brigham and Women's Hospital, Harvard Medical School, USA
Email: NA
Address: Department of Anesthesia, Brigham andWomen’s Hospital, 75 Francis St., Boston, MA 02115, USA
Duration of study: NA
Language: English
Study's primary outcome: PONV
Trial registry number: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "assign patient treatment blocks of six from a published table of random numbers; 6 patients were stratified by gender‐adjusted percent ideal body weight"
Allocation concealment (selection bias) Unclear risk Quote: "antiemetic drug preparation and randomization were performed by an unblinded research pharmacist, using a computer program to assign patient treatment blocks of six..."
Judgement comment: insufficient information on allocation concealment (unclear whether pharmacist could foresee allocation of the next patient)
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "physicians, nurses, and patients were blinded to the identity of the antiemetics"
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: no statement on blinding of outcome assessors
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "twelve patients required conversion to open cholecystectomy and therefore were eliminated from the study; thus, 200 patients completed the protocol and are included in the analysis"
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a study protocol or trial registry number reported
Other bias Unclear risk Quote: "the groups were similar with respect to gender, age, weight, duration of surgery, intraoperative fentanyl dose, and numbers receiving intraoperative atropine or ephedrine (Table 1)"
Judgement comment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear