Kim 2015a.
Methods | RCT, parallel design, single‐centre | |
Participants |
Total number of randomized participants: 60 Inclusion criteria
Exclusion criteria
Type of surgery: orthopaedic surgery (hip replacement, knee replacement, long bone fracture fixation, spinal surgery) Baseline characteristics TIVA group
Inhalational maintenance group
Country: South Korea Setting: hospital |
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Interventions |
TIVA group Participants: n = 30; 0 losses Induction details: premedication with midazolam 0.05 mg/kg im. Remifentanil and propofol based on Minto and Marsh pharmacokinetic model using TCI. Target effect‐site concentration 3 µg/mL propofol, 2.5 ng/mL remifentanil. Rocuronium 1.0 mg/kg Maintenance details: propofol‐remifentanil with 50% O2 and 50% air mix. Target effect‐site concentration 3 µg/mL propofol, 2.5 ng/mL remifentanil. Rocuronium 1.0 mg/kg. To maintain BIS near 50 (range 40 to 60) Other information: after surgery fentanyl administration using PCI Inhalational maintenance group Participants: n = 30; 2 losses (owing to surgery lasting more than 2 hours); 27 analysed Induction details: premedication with midazolam 0.05 mg/kg im. Propofol 1.5 mg/kg to 2.0 mg/kg, 3% to 4 % sevoflurane and 50% O2‐ air mixture. Rocuronium 1.0 mg/kg Maintenance details: sevoflurane with 50% O2 and 50% air mix. Adjusted to maintain BIS near 50 (range 40 to 60) Other information: fentanyl after surgery same as TIVA group |
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Outcomes |
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Notes |
Funding/declarations of interest: grants from Chosun University Medical Research Institute. Study authors declare no competing interests Study dates: not reported Note: study has four comparison groups ‐ sevoflurane vs TIVA, with and without dexmedetomidine. For the review, we have only used the comparison groups without dexmedetomidine |
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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 | Loss of 2 participants in the inhalation group; few losses unlikely to influence outcome data |
Selective reporting (reporting bias) | Low risk | Prospective trial registration (NCT01851005). Most outcomes were reported, although we noted that adverse events (secondary outcomes) were not included in the written report. For the purpose of our review, MAP was reported but not in terms of hypotension. |
Other bias | Unclear risk | Differences between groups in use of remifentanil and fentanyl. Also, a higher ratio of female to male participants; however, this is balanced between groups |