Koivuranta 1999.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, combination prophylaxis |
|
Participants |
Baseline characteristics Droperidol + ondansetron
Droperidol + tropisetron
Included criteria: female, history of previous PONV, scheduled to have elective gynaecological laparoscopic surgery, over 18 years of age, ASA I to III Excluded criteria: pregnant, breastfeeding, evidence of hepatic or other metabolic dysfunction, Parkinson's disease, currently received opioids or medication with antiemetic activity Pretreatment: baseline characteristics (age, BMI, ASA): no. Potential effect modifiers (gender, perioperative opioids, non‐smoker, history of PONV/motion sickness): no; (duration of anaesthesia): yes |
|
Interventions |
Intervention characteristics Droperidol + ondansetron
Droperidol + tropisetron
|
|
Outcomes |
Vomiting (0 to 24 hours)
Vomiting (0 to 2 hours)
Nausea (0 to 24 hours)
Subjects with any SAE (0 to 24 hours)
Extrapyramidal symptoms (0 to 24 hours)
Headache (0 to 24 hours)
Sedation/drowsiness (0 to 2 hours)
Adverse events (general notes in the publication, 24 hours' observation)
|
|
Identification |
Sponsorship source: NA Country: Finland Setting: inpatients, multi‐centre (2) Author's name: M. Koivuranta Institution: Department of Anaesthesiology, Oulu University Hospital, Ouluandt Department of Anaesthesiology, Lappland Central Hospital, Rovaniemi, Finland Email: NA Address: Department of Anaesthesiology, Oulu University Hospital, Kajaanintie 50,FIN‐90220 Oulu, Finland Language: English Duration of study: NA Trial registry number: NA Study's primary outcome: NA |
|
Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Judgement comment: quote: "randomized". No further information on sequence generation provided |
Allocation concealment (selection bias) | Low risk | Judgement comment: quote: "the treatment allocation codes were contained in sealed opaque envelopes and for each consecutive patient recruited the assisting nurses opened the next envelope in order and administered the study drug but did not participate in the post‐operative assessment" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Judgement comment: quote: "in a random double‐blind fashion to receive intravenously (i.v.) (...) either a slow injection of ondansetron 8 mg or tropisetron 5 mg, diluted to the same volume of saline"; "the assisting nurses opened the next envelope in order and administered the study drug but did not participate in the post‐operative assessment" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Judgement comment: quote: "all observations were made without the interviewer being aware of the study treatment"; "all observations were made without the interviewer being aware of the study treatment" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: quote: "two patients were excluded from the final analysis because of a protocol violation" |
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: quote: "furthermore, this was in spite of the fact that the patients in the ondansetron group had a higher incidence of motion sickness, received a longer anaesthetic and larger dose of fentanyl" Baseline characteristics (age, BMI, ASA): no. Potential effect modifiers (gender, perioperative opioids, non‐smoker, history of PONV/motion sickness): no; (duration of anaesthesia): yes |