Pedersen 1993.
Methods | Single‐centre RCT | |
Participants |
Setting: Herlev hospital, Herlev, Denmark Inclusion criteria: 44 ASA I‐II patients, aged 30 to 65 years, scheduled for elective abdominal hysterectomy with or without salpingo oophorectomy Exclusion criteria: patients with gastrointestinal disease of any kind, malignancy, or weight < 45 kg or > 90 kg; preoperative medication known to interfere with bowel function; contraindications against any of the anaesthetics used; insertion of a nasogastric tube; surgical complications; administration of laxatives or enemas before the fourth day postoperatively (the operation day being day 0) Participant numbers: 44 randomly assigned; 36 analysed |
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Interventions | Intervention: diazepam 0.15 mg/kg administered orally 1 h before anaesthesia was used as premedication. Anaesthesia was induced with fentanyl 3 μg/kg and atracurium as precurarization followed by thiopentone 3 to 5 mg/kg. Intubation was facilitated by suxamethonium 1.5 mg/kg. Anaesthesia was maintained with fentanyl 2 μg/kg/h and isoflurane with nitrous oxide in 30% oxygen. Ventilation was adjusted to maintain end‐tidal carbon dioxide tension between 4 and 4.5 kPa. After the disappearance of the effect of suxamethonium, neuromuscular block was achieved with a bolus of atracurium, 0.3 mg/kg, and maintained with infusion of atracurium. Control: diazepam 0.15 mg/kg administered orally 1 h before anaesthesia was used as premedication. Anaesthesia was induced with fentanyl 3 μg/kg and atracurium as precurarization followed by thiopentone 3 to 5 mg/kg. Intubation was facilitated by suxamethonium 1.5 mg/kg. Anaesthesia was maintained with fentanyl 2 μg/kg/h and isoflurane in 30% oxygen. Ventilation was adjusted to maintain end‐tidal carbon dioxide tension between 4 and 4.5 kPa. After the disappearance of the effect of suxamethonium, neuromuscular block was achieved with a bolus of atracurium, 0.3 mg/kg, and maintained with infusion of atracurium. | |
Outcomes |
Secondary outcomes: Severe nausea and vomiting: patient rated |
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Notes | 8 patients were excluded during the study: 3 patients because of per‐ or postoperative surgical complications, 1 patient because of the surgeon's wish for insertion of a nasogastric tube due to distension of the intestines (the patient received nitrous oxide), 3 patients due to erroneous administration of laxative on the second postoperative day and 1 patient because of severe gastrointestinal discomfort on the third day postoperatively requiring an enema (the patient received nitrous oxide). | |
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 | Low risk | Quote: "The mixture of gas administered was blinded for everyone other than the anaesthetist." |
Blinding of outcome assessment (detection bias) Inhospital case fatality rate/length of stay | Unclear risk | — |
Blinding of outcome assessment (detection bias) Complications | Low risk | Quote: "Nausea and vomiting were assessed by an investigator other than the anaesthetist or the surgeon." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information. |
Selective reporting (reporting bias) | Low risk | All outcomes described in methods section reported. |
Other bias | High risk | Fewer than 50 participants per arm. |