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. 2018 Aug 21;2018(8):CD012317. doi: 10.1002/14651858.CD012317.pub2

Nishikawa 2004.

Methods RCT, parallel design, single‐centre
Participants Total number of randomized participants: 50
Inclusion criteria
  1. ASA I or II, > 65 years of age, scheduled for elective laparoscope‐assisted surgical procedures which would last > 3 hours, under combined GA and epidural anaesthesia


Exclusion criteria
  1. People with anticoagulation, symptomatic coronary artery disease, cardiac valvular regurgitation or stenosis, central nervous system or neuromuscular disorders

  2. Major or minor tranquillizer medication

  3. Psychotic symptoms or cognitive impairment as judged by a psychiatrist


Type of surgery: laparoscopic surgery (choledocholithotomy, colectomy, sigmoidectomy)
Baseline characteristics
TIVA group
  1. Age, mean (SD): 71 (± 8) years

  2. Gender, M/F: 13/12

  3. ASA grade: ASA I: 7; ASA II: 18


Inhalational maintenance group
  1. Age, mean (SD): 71 (± 7) years

  2. Gender, M/F: 12/13

  3. ASA grade: ASA I: 6; ASA II: 19


Country: Japan
Setting: hospital
Interventions TIVA group
Participants: n = 25; 0 losses
Induction details: 100% O2 via face mask for 3 minutes prior to induction. Induction with propofol using 4 µg/mL TCI. Use of 2% lidocaine solution for injection pain
Maintenance details: 4 µg/mL propofol TCI. Study authors report mean (SD) range of 1.2 (± 0.2) µg/mL to 2.7 (± 0.2) µg/mL propofol. Use of clinical signs to maintain anaesthesia
Additional regional anaesthesia: epidural anaesthesia: 6 mL to 8 mL of 1.5% lidocaine, followed by continuous epidural administration at a rate of 4 mL/hour to 6 mL/hour throughout surgery
Inhalational maintenance group
Participants: n = 25; 0 losses
Induction details: 100% oxygen via face mask for 3 minutes prior to induction. 5% sevoflurane and 100% oxygen at 6 L/min until inspired limb‐drug concentration was > 4%. Vecuronium 0.1 mg/kg.
Maintenance details: sevoflurane with O2/air mix at total gas flow of 3 L/min. Vecuronium 1 mg to 2 mg IV boluses as required. Study authors report mean (SD) range of 0.9% (± 0.1%) to 1.7% (± 0.4%) sevoflurane
Outcomes
  1. Duration of anaesthesia

  2. Duration of surgery

  3. Intraoperative complications (hypotension, bradycardia, hypertension, tachycardia, increased salivation)

  4. Postoperative delirium (using DRS)

  5. Pain (using VAS)

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) Unclear risk Participants were "randomly assigned by a sealed envelope technique". Insufficient information
Allocation concealment (selection bias) Unclear risk Described as "randomly assigned by a sealed envelope technique". Insufficient information
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 Delirium was assessed by a psychiatrist blinded to intervention group. Data on emergence times was assessed by a nurse who was blinded to intervention group.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No apparent loss of study participants
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 Low risk No other source of bias identified