Swiatkowski 1999.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Ondansetron
Droperidol
Included criteria: ASA I and II, scheduled for laparoscopic surgery (laparoscopic cholecystectomy or minor gynaecological laparoscopic surgery) Excluded criteria: preoperative nausea or vomiting requiring therapy; current use of antiemetics, benzodiazepines, or phenothiazine derivatives; previous dyskinetic reactions to droperidol; previous allergy to any of the drugs involved in the study; history of epilepsy; gastrointestinal reflux; liver or renal impairment; use of prostaglandins or ergometrine before or during the procedure Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear |
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Interventions |
Intervention characteristics Ondansetron
Droperidol
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Outcomes |
Vomiting (6 to 12 hours)
Extrapyramidal symptoms (acute dyskinesia, 0 to 24 hours)
Sedation/drowsiness (0 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: Glaxo Wellcome Polska supplied ondansetron Country: Poland Setting: inpatient, single‐centre Author's name: J. Świa̧tkowski Institution: University Department of Anaesthesiology and Intensive Therapy, Medical University School, Lublin, Poland Email: NA Address: University Department of Anaesthesiology and Intensive Therapy, Medical University School, Jaczewskiego 8, 20‐090 Lublin, Poland Duration of study: NA Language: English Study's primary outcome: incidence of 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) | Unclear risk | Quote: "they were randomized to receive either ondansetron (Glaxo Wellcome Polska..." Judgement comment: no 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 | Quote: "neither the patient nor the observer during the post‐operative period knew which drug had been administered" Quote: "...both given intravenously (i.v.) by the attending anaesthetist immediately after induction of anaesthesia and before the surgery" Judgement comment: insufficient information on blinding of anaesthetists |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "neither the patient nor the observer during the post‐operative period knew which drug had been administered" |
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 | Unclear risk | Quote: "the patients in the two groups treated with droperidol or ondansetron were comparable with regard to the demographic data shown in Table 1. There was no significant difference between two groups" Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear |