Jensen 1993a.
Methods | Single‐centre RCT | |
Participants |
Setting: University Hospital Linköping, Linköping, Sweden Inclusion criteria: patients > 18 years, scheduled for laparoscopic cholecystectomy Participant numbers: 42 randomly assigned; 42 analysed for the outcome of pneumonia; 40 analysed for the outcome of length of hospital stay |
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Interventions | Intervention: patients received meperidine 1 mg/kg and atropine 6 μg/kg im for premedication approximately 45 min prior to anaesthetic induction. Anaesthesia was induced intravenously with fentanyl 2 μg/kg, and thiopental 4 to 6 mg/kg was administered until loss of eyelash reflex. Tracheal intubation was facilitated by the use of succinylcholine 1 mg/kg after pretreatment with vecuronium 1 mg. The patients received isoflurane with nitrous oxide in oxygen for maintenance of anaesthesia. An inspiratory fraction of oxygen of 0.3 was used. Control: patients received meperidine 1 mg/kg and atropine 6 μg/kg im for premedication approximately 45 min prior to anaesthetic induction. Anaesthesia was induced intravenously with fentanyl 2 μg/kg, and thiopental 4 to 6 mg/kg was administered until loss of eyelash reflex. Tracheal intubation was facilitated by the use of succinylcholine 1 mg/kg after pretreatment with vecuronium 1 mg. The patients received isoflurane with air in oxygen for maintenance of anaesthesia. An inspiratory fraction of oxygen of 0.3 was used. | |
Outcomes |
Secondary outcomes: Pneumonia: no specific definition Length of hospital stay |
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Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomized but no further details. |
Allocation concealment (selection bias) | Unclear risk | No details given. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Described as double‐blind but no further details. |
Blinding of outcome assessment (detection bias) Inhospital case fatality rate/length of stay | Low risk | The outcome measurement is not likely to be influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) Complications | Low risk | Quote: "Postoperative data was assessed by the postoperative ward staff and surgeon blinded to the anaesthetic technique." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups. |
Selective reporting (reporting bias) | Low risk | All outcomes described in methods section reported. |
Other bias | High risk | Fewer than 50 participants per arm. |