Dabbous 2010.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, combination prophylaxis |
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Participants |
Baseline characteristics Granisetron + dexamethasone
Ondansetron + dexamethasone
Included criteria: ASA I or II, scheduled for laparoscopic cholecystectomy or herniorrhaphy Excluded criteria: known allergies or hypersensitivity to study drugs, history of chronic nausea and vomiting or experienced nausea and vomiting in the past 24 hours before anaesthesia, had received any antiemetics or any drug with antiemetic properties during the 24 hours before anaesthesia, BMI ≥ 35 kg/m², over 70 years of age, pregnant or breastfeeding, had a condition requiring long‐term opioid use Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness): no; (perioperative opioids): unclear |
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Interventions |
Intervention characteristics Granisetron + dexamethasone
Ondansetron + dexamethasone
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Outcomes |
Vomiting (6 to 24 hours)
Headache (PACU)
Sedation/drowsiness (PACU)
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: NA Country: Lebanon Setting: inpatient, single‐centre Author's name: Alia Dabbous Institution: Department of Anesthesiology, American University of Beirut Medical Center, Beirut, Lebanon Email: ad00@aub.edu.lb Address: Department of Anesthesiology, American University of Beirut. P.O. Box 11‐0236, Beirut 1107‐2020, Lebanon 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) | Low risk | Quote: "using a computer generated randomization method" |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: no statement |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "were presented to blinded investigators as identical 2 ml filled syringes" Quote: "the study medications were prepared by a resident, who was not involved in any other part of the study, and were presented to blinded investigators..." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "adverse events were evaluated and recorded by a resident who was blinded to the study drugs used" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "of the 100 patients initially signing the informed consent, 84 patients (42 in group I, 42 in group II) completed the study" Judgement comment: missing data > 15%. No reasons mentioned for loss of participants |
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 was no statistically significant difference between the two groups in regards to gender, history of PONV and history of motion sickness, age, weight, type of surgery (laparoscopic cholecystectomy or laparoscopic herniorraphy), duration of surgery, history of prolonged gastric emptying, and smoking history (Table 1)" Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness): no; (perioperative opioids): unclear |