Chen 2013.
Methods | Single‐centre RCT | |
Participants |
Setting: Prince of Wales Hospital, Hong Kong, China Inclusion criteria: ASA I‐IV patients, aged > 18 years, scheduled for elective open colorectal surgery Exclusion criteria: patients with ongoing infection and those with fever in the 24 h before surgery; patients with marked impairment of gaseous exchange; surgery for which primary wound closure; in the opinion of the attending anaesthesiologist that nitrous oxide administration was contraindicated Participant numbers: 93 randomly assigned; 91 analysed |
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Interventions | Intervention: anaesthesia was induced with propofol 1 to 2.5 mg/kg. Patients received sevoflurane targeted to achieve a bispectral index value between 40 and 60. Intraoperative analgesia was provided by remifentanil infusion 0.1 to 0.5 μg/kg/min and intravenous morphine 0.1 to 0.15 mg/kg, 30 min before completion. Muscle relaxation was facilitated by rocuronium. The lungs were ventilated through a tracheal tube using 70% nitrous oxide and 30% oxygen. Control: anaesthesia was induced with propofol 1 to 2.5 mg/kg. Patients received sevoflurane targeted to achieve a bispectral index value between 40 and 60. Intraoperative analgesia was provided by remifentanil infusion 0.1 to 0.5 μg/kg/min and intravenous morphine 0.1 to 0.15 mg/kg, 30 min before completion. Muscle relaxation was facilitated by rocuronium. The lungs were ventilated through a tracheal tube using either 30% oxygen with 70% nitrogen or 80% oxygen with 20% nitrogen. | |
Outcomes |
Primary outcomes: Inhospital case fatality rate Secondary outcomes: Myocardial infarction: The diagnosis of myocardial infarction required any one of the following criteria:
This criterion also required that one of the following must also exist:
Pneumonia: The definition of pneumonia required any one of the following criteria:
Wound infection: diagnosed by ASEPSIS > 20 Length of hospital stay |
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Notes | Two patients were excluded after randomization because their surgeries were cancelled | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were randomly allocated from a computer‐generated list." |
Allocation concealment (selection bias) | Low risk | The random sequence was accessed through an intranet system. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | This was not reported. |
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: "The complications were examined by ward medical staff who were unaware of the allocated group identity." |
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. |