Sniadach 1997.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Ondansetron
Droperidol
Included criteria: women undergoing outpatient laparoscopic gynaecological surgery under general anaesthesia, ASA I or II, 18 to 50 years of age, anaesthesia time less than 2 hours Excluded criteria: known hypersensitivity to any antiemetic Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear |
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Interventions |
Intervention characteristics Ondansetron
Droperidol
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Outcomes |
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: funded by a grant from Kaiser Permanente of Colorado Country: USA Setting: outpatient, single‐centre Author's name: M. Steve Sniadach Institution: Department of Anesthesiology, Saint Joseph Hospital, Kaiser Permanente Medical Center, Denver, USA Email: NA Address: Department of Anesthesiology, Saint Joseph Hospital, Kaiser Permanente Medical Center, 2045 Franklin St., Denver, CO 80205 Duration of study: NA Language: English Study's primary outcome: NA 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: "prospectively randomized to receive either droperidol..." Judgement comment: 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 | Low risk | Quote: "...mg) during induction of anesthesia. Study medications were prepared by a single pharmacist in identical syringes, with identical volumes, to ensure blind administration by the anesthesiologist and preoperative nurses. No other antiemetics were given" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "...within 3 days after surgery. The first two assessments were made by 1 of a group of 10 PACU nurses blinded to the medication each patient had received, who asked the subjects about..." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "of the original 160 subjects, 2 were excluded from the study because of failure to receive the study medication at induction, and 2 were excluded because they had received an extra intraoperative antiemetic dose. All four excluded patients had been assigned to receive droperidol. Therefore, data from 156 patients were analyzed" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | Unclear risk | Quote: "...groups. Neither were differences found between groups in variables that could have potentially influenced nausea and sedation outcomes, including average operation time, average anesthesia time, average PACU time, and average fentanyl dose. No difference in group distribution among types of surgery was noted" Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear |