Steinbrook 1998.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 3 groups, monoprophylaxis and combination prophylaxis |
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Participants |
Baseline characteristics Ondansetron + droperidol
Droperidol + metoclopramide
Perphenazine
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 |
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Interventions |
Intervention characteristics Ondansetron + droperidol
Droperidol + metoclopramide
Perphenazine
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Outcomes |
Vomiting (0 to 2 hours)
Vomiting (2 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
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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 |
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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 |