Lindholm 2013.
Methods | RCT, parallel design, single‐centre | |
Participants |
Total number of randomized participants: 200 Inclusion criteria
Excluded criteria
Type of surgery: open abdominal aortic surgery Baseline characteristics TIVA group
Inhalational maintenance group
Country: Norway Setting: hospital |
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Interventions |
TIVA group Participants: n = 100; losses unclearly reported; 96 analysed (PP) Induction details : premedication with paracetamol. Fentanyl 0.1 mg to 0.3 mg IV, and propofol 1 mg/kg to 2 mg/kg IV. Vecuronium 0.1 mg/kg, and 0.01 mg/kg to 0.02 mg/kg based on train‐of‐four Maintenance details: propofol 1 mg/kg/hour to 10 mg/kg/hour IV, and remifentanil 0.1 mg/kg/min to 0.7 mg/kg/min. Aim to maintain BIS 40 to 60. Additional regional anaesthesia: epidural 3 mL/hour to 12 mL/hour (bupivacaine 1 mg/mL, fentanyl 2 µg/mL, adrenaline 2 µg/mL) Other information: morphine 1 mg to 10 mg IV as rescue analgesia Inhalational maintenance group Participants: n = 100; losses unclearly reported; 97 analysed (PP) Induction details : premedication with paracetamol as for TIVA. Fentanyl 0.1 mg to 0.3 mg IV and thiopental sodium 3 mg/kg to 6 mg/kg IV. Vecuronium as for TIVA Maintenance details: balanced anaesthesia with sevoflurane at 0.7 MAC to 1.5 MAC, and repeated doses of fentanyl 0.05 mg to 0.1 mg IV. Aim to maintain BIS 40 to 60 Additional regional anaesthesia: epidural 3 mL/hour to 12 mL/hour (bupivacaine 1 mg/mL, fentanyl 2 µg/mL, adrenaline 2 µg/mL) Other information: morphine same as TIVA group |
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Outcomes |
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Notes |
Funding/declarations of interest: institution or department funding. One author received fees for presentations at Baxter AS Norway Study dates: February 2008 to February 2012 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants were randomized to groups; no additional details |
Allocation concealment (selection bias) | Unclear risk | Quote: "after informed consent was given, patients selected a blank envelope with the randomization code inside from a box containing envelopes for all remaining patients to be included." Study does not report if envelopes were opaque and sealed. Unclear if this is a sufficient method to conceal group allocation |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not feasible to blind anaesthetists to intervention groups |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Postoperative care was blinded. However, study authors do not report who collected data for POCD |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Small loss of participant data. Reasons for losses are unclearly reported, however loss is < 10% and balanced between groups |
Selective reporting (reporting bias) | Unclear risk | Prospective registration with clinical trials register (NCT00538421). However, outcomes are not reported in trials register documents; not feasible to assess risk of selective outcome reporting bias |
Other bias | Unclear risk | Groups differ in use of fentanyl and remifentanil which presents methodological differences between groups |