Naghibi 2015.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Metoclopramide (group G3)
Placebo (group G4)
Included criteria: ASA I and II, 18 to 65 years of age, were scheduled for elective lower abdominal surgery under general anaesthesia Excluded criteria: risk factor of PONV or prior history of motion sickness or PONV and administration of an antiemetic before surgery; history of drug or alcohol abuse; body mass index (BMI) > 30 kg/m²; any unpredictable condition in surgery or any complication such as severe hypotension (whenever systolic blood pressure (SBP) was < 70% of baseline); bleeding more than 10% of total blood volume 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 Metoclopramide (group G3)
Placebo (group G4)
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Outcomes |
Vomiting (0 to 24 hours)
Nausea (0 to 24 hours)
Headache (0 to 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: study authors have no funding or support to report Country: Iran Setting: inpatient, single‐centre Author's name: Azarnoush Hamed Institution: Department of Anesthesiology, Alzahra University Hospital, Isfahan University of Medical Sciences, Isfahan, Iran Email: hamedmds@yahoo.com Address: NA Duration of study: in 2009 Language: English Study's primary outcome: nausea, VAS scoring Trial registry number: NA |
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Notes | Two out of 4 groups relevant | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "patients were randomly allocated into one of four groups (Propofol 20 mg (G1), Propofol 30 mg (G2), Metoclopramide 10 mg (G3), or isotonic saline as a placebo (G4)) using sealed envelopes, with 26 patients in each group" Judgement comment: no further information on sequence generation provided (shuffling envelopes?) |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: not stated; "sequentially numbered, opaque, and sealed envelopes" (SNOSE) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the injected drugs were prepared in identical syringes by a researcher not otherwise involved in this study" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "...recorded. These variables were assessed by the investigators unaware of the group identities and subdivided into three time periods, 0‑6 h, 6‑12 h, and 12‑24 h, postoperatively" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 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: "the four groups of patients were comparable with respect to sex, mean age, weight, height, male to female ratio, ASA physical status, and duration of surgery and also recovery time [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 |