Tylman 2011.
Methods | RCT, parallel design, single‐centre | |
Participants |
Total number of randomized participants: 50 Inclusion criteria
Exclusion criteria
Types of surgery: colorectal surgery for rectal or colon cancer Baseline characteristics TIVA group
Inhalational maintenance group
Country: Sweden Setting: hospital |
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Interventions |
TIVA group Participants: n = 25; 0 losses Induction details : propofol TCI 3 µg/mL. Continuous infusion of remifentanil 0.25 µg/kg/min Maintenance details: propofol 2 µg/mL. Remifentanil 0.15 µg/kg/min Additional regional anaesthesia: epidural anaesthesia of 5 mg/mL bupivacaine, and 5 µg/mL epinephrine at rate of 4 mL to 5 mL during surgery. Postoperatively participants epidural changed to 1 mg/mL bupivacaine, 2 µg/mL fentanyl, 2 µg/mL epinephrine at rate of 5 mL/hour to 12 mL/hour Other information: before induction of anaesthesia participants given 1 µg/kg to 2 µg/kg fentanyl IV, and standard dose of rocuronium Inhalational maintenance group Participants: n = 25; 4 losses (did not meet study inclusion criteria); 21 analysed Induction/maintenance details: sevoflurane with 60% O2 throughout surgery. Concentration not reported. We assume that induction was also with sevoflurane Additional regional anaesthesia: epidural anaesthesia of 5 mg/mL bupivacaine, and 5 µg/mL epinephrine at rate of 4mL to 5 mL during surgery. Postoperatively participants epidural changed to 1 mg/mL bupivacaine, 2 µg/mL fentanyl, 2 µg/mL epinephrine at rate of 5 mL/hour to 12 mL/hour Other information: fentanyl and rocuronium same as TIVA group |
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Outcomes |
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Notes |
Funding/declarations of interest: not reported Study dates: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants were randomly assigned to groups; no additional details |
Allocation concealment (selection bias) | Unclear risk | No details |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not feasible to blind anaesthetist to intervention groups. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss of participants (all in inhalation group) after randomization because these participants were diagnosed with additional conditions (ulcerative colitis and Crohn's disease). Decision to remove these participants was to avoid confounding. Post‐hoc decision which is imbalanced between groups |
Selective reporting (reporting bias) | Unclear risk | Study authors do not report clinical trials registration. Not feasible to judge risk of selective outcome reporting |
Other bias | Unclear risk | Differences in groups in use of remifentanil and fentanyl. Also, study authors do not report concentration of sevoflurane. Note limited information in baseline characteristics table, and lack of inclusion/exclusion criteria |