Jellish 2003.
Methods | RCT, parallel design, single‐centre | |
Participants |
Total number of randomized participants: 60 (unclearly reported in paper, possibly 59 randomized participants) Inclusion criteria
Exclusion criteria
Type or surgery: carotid endarterectomy Baseline characteristics TIVA group
Inhalational maintenance group
Country: USA Setting: single‐centre |
|
Interventions |
TIVA group Participants: n = 30; 0 losses Induction details : propofol 1.0 mg/kg to 1.5 mg/kg IV. Remifentanil infusion started at 0.25 µg/kg/min. Additional propofol 25 mg to 50 mg IV given if necessary to maintain MAP within 10 % pre‐induction values during intubation Maintenance details: propofol 50 µg/kg/min to 75 µg/kg/min. Remifentanil 0.125 µg/kg/min to 0.5 µg/kg/min. Adjusted to maintain haemodynamic parameters within 15% pre‐induction. N2O in O2 mix 60/40 Other information: hypertension non‐responsive to anaesthesia treated with sodium nitroprusside 0.5 µg/kg/min. Hypotension non‐responsive to anaesthesia treated with phenylephrine 40 µg to 80 µg IV. Tachycardia unresponsive to anaesthesia treated with esmolol 10 mg to mg 20 mg IV, bradycardia treated with glycopyrrolate 0.2 mg IV Inhalational maintenance group Participants: number of randomized participants is unclearly reported. We have assumed that 30 participants were randomized, with 1 loss (owing to technical difficulties with transoesophageal probe), and 29 participants were analysed. Induction details: propofol 1.5 mg/kg to 2 mg/kg IV, fentanyl 2 µg/kg. Additional propofol 25 mg to 50 mg IV given if necessary to maintain MAP within 10 % pre‐induction values during intubation Maintenance details: isoflurane 0.5% to 2% end‐tidal. Titrated to maintain MAP 15% pre‐induction values. N2O in O2 mix 60/40 Other information: other drugs to maintain stability same as TIVA group |
|
Outcomes |
|
|
Notes |
Funding/declarations of interest: not reported Study dates: not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Use of computer generated 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 | Unclear risk | No details |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One participant lost from inhalation group, which is unclearly reported. We have assumed that 30 participants were randomized to the inhalation group, with one loss. We were not concerned by risk of attrition bias because losses were few and unlikely to 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 | Study includes comparison of remifentanil with fentanyl, which introduces methodological differences between groups. Also note differences in amount of propofol given at induction |