Ibrahim 2013.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 4 groups, monoprophylaxis, dose‐finding study |
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Participants |
Baseline characteristics Placebo
Olanzapine (5 mg group)
Olanzapine (10 mg group)
Ondansetron
Included criteria: females scheduled for breast surgery (mastectomy, tumour biopsy, reductive mastoplasty, other plastic surgery), ASA I or II Excluded criteria: pre‐existing nausea, vomiting, or motion sickness; receiving opioids or drugs with known antiemetic properties in the 24 hours before surgery; history of oesophageal reflux or opioid or alcohol abuse; serum creatinine > 2.0 mg/dL; serum alanine aminotransferase (ALT) or aspartate transaminase (AST) > 2 times the upper limit of normal; body weight twice the ideal body weight Pretreatment: baseline characteristics (age, BMI, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of motion sickness): no; (history of PONV): unclear |
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Interventions |
Intervention characteristics Placebo
Olanzapine (5 mg group)
Olanzapine (10 mg group)
Ondansetron
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Outcomes |
Vomiting (0 to 2 hours)
Vomiting (2 to 24 hours)
Subjects with any SAE (0 to 24 hours)
Arrhythmia (0 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: NA Country: Egypt Setting: inpatient, single‐centre Author's name: Mohamed Ibrahim Institution: Department of Anaesthesia, Zagazig University, Egypt Email: mibrahim72@windowslive.com Address: Palestine Madina Road, P.O. Box 7692, Jeddah 21472, Saudi Arabia Duration of study: NA Language: English Study's primary outcome: emetic episodes and occurrence of nausea 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: "patients were randomly allocated to one of four groups" Judgement comment: no further information on sequence generation provided |
Allocation concealment (selection bias) | Unclear risk | Quote: "after a patient was assigned to a treatment group, the assignment was recorded and placed in a sealed envelope by a person not involved in the study. A pharmacist, who was also not involved in the study, prepared the study medications and sealed it in an envelope" Judgement comment: it is unclear how the allocation was done |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "to ensure blindness, placebo drug was given in OL5 and OL10 groups 1 h before induction and 4 h before induction in ON16. Placebo group of patients received sugar pills 4 and 1 h before induction" Quote: "a nurse or a physician, who was blinded to the patient treatment groups, gave the study drugs and recorded preoperative and postoperative data" Quote: "a pharmacist, who was also not involved in the study, prepared the study medication and sealed it in an envelope" Quote: "the trial arms in the study were blinded in spite of different olanzapine and ondansetron pharmacokinetics that affect time of drug administration" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "a nurse or a physician, who was blinded to the patient treatment groups, gave the study drugs and recorded preoperative and postoperative data" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "eighty‐two patients were included in the study" 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: "there were no significant differences in patients’ characteristics between treatment groups, including relation of surgery time with stage of menstrual cycle. The mean duration of anesthesia and duration of operation were not different. Also, no significant differences were noted among groups with respect to surgery type (Table 1)" Judgement comment: baseline characteristics (age, BMI, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of motion sickness): no; (history of PONV): unclear |