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

NCT02662257.

Trial name or title Impact of anaesthesia maintenance methods on incidence of postoperative delirium
Methods RCT, parallel design
Participants Target number of randomized participants: 1200
Inclusion criteria
  1. ≥ 65 years and < 90 years of age

  2. Primary malignant tumour

  3. Not receiving radiation therapy or chemotherapy before surgery

  4. Scheduled to undergo surgery for the treatment of tumours, with an expected duration of ≥ 2 hours, under GA

  5. Agree to participate, and give signed written informed consent


Exclusion criteria:
  1. Preoperative history of schizophrenia, epilepsy, parkinsonism or myasthenia gravis

  2. Inability to communicate in the preoperative period (coma, profound dementia, language barrier, or end‐stage disease)

  3. Critical illness (preoperative ASA ≥ IV)

  4. Severe hepatic dysfunction (Child‐Pugh class C)

  5. Severe renal dysfunction (undergoing dialysis before surgery)

  6. Neurosurgery

  7. Other reasons that are considered unsuitable for participation by the responsible surgeons or investigators


Type of surgery: treatment of tumour
Country: China
Setting: hospital
Interventions TIVA group
Details: propofol adjusted to maintain BIS 40 to 60, with or without 50% nitrous oxide. Remifentanil (administered by continuous infusion), sufentanil (administered by intermittent injection/continuous infusion), or fentanyl (administered by intermittent injection). Towards the end of surgery, propofol infusion rate will be decreased and fentanyl/sufentanil will be administered when necessary
Inhalational maintenance group
Details: sevoflurane adjusted to maintain BIS 40 to 60, with or without 50% nitrous oxide. Remifentanil (administered by continuous infusion), sufentanil (administered by intermittent injection/continuous infusion), or fentanyl (administered by intermittent injection). Towards the end of surgery, sevoflurane inhalational concentration will be decreased and fentanyl/sufentanil will be administered when necessary
Outcomes
  1. Delirium (using CAM or CAM‐ICU, at 7 days postoperatively)

  2. Length of hospital stay (up to 30 days)

  3. Incidence of non‐delirium complications (up to 30 days)

  4. Cognitive function (using TICS‐m at 30 days)

  5. All‐cause 30‐day mortality

  6. Pain score (during first 3 days postoperatively)

  7. Cognitive function at 7 days postoperatively

Starting date April 2015
Contact information Dong‐Xin Wang, MD, PhD, Peking University FIrst Hospital
Notes Also registered as ChiCTR‐IPR‐15006209