Cai 2012a.
Methods | RCT, parallel design, single‐centre | |
Participants |
Total number of randomized participants: 2216 Inclusion criteria
Exclusion criteria
Type of surgery: oesophagectomy, gastrectomy, nephrectomy, fracture reduction Baseline characteristics TIVA group
Inhalational maintenance group
Country: China Setting: hospital |
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Interventions |
TIVA group Participants: n = 1106; 106 losses (anastomotic leaks, bleeding, respiratory failure, heart failure, inflammation); 1106 analysed using ITT: 1000 analysed PP Induction details: loading doses of fentanyl 4 µg/kg, propofol 3 mg/kg and vecuronium 0.08 mg/kg Maintenance details: fentanyl continuous infusion 0.03 µg/kg/min, propofol continuous infusion at a rate of 53.8 µg/kg/min injected with gradual increases in concentration of 0.4 µg/mL with initial target level of 1 µg/mL. Continuous infusion of vecuronium 0.5 µg/kg/min. BIS maintained at 40 to 60 Other information: premedication with 10 mg diazepam, 0.5 mg atropine im 30 minutes before GA Inhalational maintenance group Participants: n = 1110; 110 losses (anastomotic leaks, bleeding, respiratory failure, heart failure, inflammation); 1110 analysed using ITT; 1000 analysed PP Induction details: loading doses of fentanyl 4 µg/kg, propofol 3 mg/kg and vecuronium 0.08 mg/kg Maintenance details: continuous inhalation 2% to 3% end‐tidal concentration isoflurane. Continuous infusion of vecuronium 0.5 µg/kg/min. BIS maintained at 40 to 60 Other information: premedication same as TIVA group |
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Outcomes |
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Notes |
Funding/declarations of interest: supported by grants from National Nature Science Foundation of China, and by Doctor funding Study dates: 2005 to 2010 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Use of a computerized random number generator and block randomization |
Allocation concealment (selection bias) | Unclear risk | No details |
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 | Low risk | Postoperative assessment of MMSE was carried out by psychiatrists who were blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Reasons for losses are described and balanced between group but number of losses is large (> 10%) and we were unclear whether this could influence outcome data |
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 | We noted a discrepancy between table 2 and the text in results section of the study report. Table 2 reports a big difference in MMSE scores at baseline, with very low scores in the inhalation group, and text reports no difference at baseline. We have assumed that table 2 has a typo, because baseline MMSE score is unusually low. We noted that data in this study differed from other studies. We did not identify any differences that could explain this, and we could not be certain whether other sources of unidentified bias were present |