Grond 1995.
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, 18 to 65 years of age, presenting for elective diagnostic procedures of the uterus or adnexa Excluded criteria: pregnancy, drug dependence, psychiatric illness, intolerance to ondansetron or droperidol, pre‐existing nausea, intake of antiemetics 24 hours before the study, as well as respiratory, cardiovascular, hepatic, renal, or metabolic disorders 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 |
Vomiting (0 to 24 hours)
Nausea (0 to 24 hours)
Complete response (no PONV) in 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: NA Country: Germany Setting: inpatient, single‐centre Author's name: Stefan Grond Institution: Department of Anesthesiology and Operative Intensive Care, University of Cologne, Cologne, Germany Email: NA Address: Klinik für Anaesthesiologie und Operative Intensivmedizin, Universität zu Köln, D‐50924 Köln, Germany Language: English Duration of study: NA Trial registry number: NA Study's primary outcome: NA |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "were prospectively randomized to receive either ondansetron or droperidol in a double‐blind..." Judgement comment: no further information on randomization method provided |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: no statement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "the syringes containing the study medication were prepared by a nurse otherwise not participating in the study" Judgement comment: no further information on blinding of personnel and identical appearance of syringes provided |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "all patients were observed by the same recovery room nurse, who did not otherwise participate in the study. During the following 22 h, the patients were monitored on the general ward by nurses who were familiar with the study" Judgement comment: insufficient information on blinding of outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "forty patients received ondansetron and 40 received droperidol. All of them completed the study" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | Unclear risk | Quote: "there were no significant differences between the groups with respect to patient characteristics, type of surgery, duration of anesthesia, and doses of anesthetics (Table 1)" 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 |