Impact of Anesthesia Maintenance Methods on Incidence of Postoperative Delirium

NCT02662257 | Completed DMC

• 2 other identifiers: 2015[869]-1ChiCTR-IPR-15006209
• Study Type: interventional
• Target: 1,228
• Locations: 1 country
• Sites: 17

Brief Summary

Surgery is one of the major treatment methods for patients with malignant tumor. And, alone with ageing process, more and more elderly patients undergo surgery for malignant tumor. Evidence emerges that choice of anesthetics, i.e., either inhalational or intravenous anesthetics, may influence the outcome of elderly patients undergoing cancer surgery. Delirium is a commonly occurred early postoperative cognitive complication in the elderly, and its occurrence is associated with the worsening outcomes. Choice anesthetics may influence the occurrence of postoperative delirium. However, evidence in this aspect is conflicting.

Conditions

Delirium; Postoperative Complications; Postoperative Cognitive Dysfunction

Keywords

Sevoflurane; Propofol; Aged; Neoplasm; Surgical Procedure, Operative; Delirium; Postoperative Complications; Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• Incidence of delirium within 7 days after surgery.

  Delirium is assessed twice daily (8-10 AM and 6-8 PM) with the Confusion Assessment Method for patients without endotracheal intubation or the Confusion Assessment Method for the Intensive Care Unit for patients with endotracheal intubation.

  Up to 7 days after surgery

Secondary Outcomes (6)

• Percentage of intensive care unit (ICU) admission after surgery.

  Within 24 hours after surgery.

• Percentage of ICU admission with endotracheal intubation after surgery.

  Within 24 hours after surgery.

• Length of stay in ICU after surgery.

  Up to 30 days after surgery.

• Length of stay in hospital after surgery.

  Up to 30 days after surgery.

• Incidence of non-delirium complications within 30 days.

  Up to 30 days after surgery.

Other Outcomes (4)

• Intensity of pain within 3 days after surgery.

  Up to 3 days after surgery.

• Subjective sleep quality within 7 days after surgery.

  Up to 7 days after surgery.

• Cognitive dysfunction assessment

  The day before surgery and on the 7th day after surgery

Study Arms (2)

Sevoflurane group

ACTIVE COMPARATOR

Sevoflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled sevoflurane will be adjusted to maintain the bispectral index (BIS) value between 40 and 60. Analgesia will be supplemented with 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. Sevoflurane inhalation will be stopped at the end of surgery.

Drug: Sevoflurane

Propofol group

EXPERIMENTAL

Propofol will be administered by intravenous infusion for anesthesia maintenance. The infusion rate of propofol will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be supplemented with 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. Propofol infusion will be stopped at the end of surgery.

Drug: Propofol

Interventions

Sevoflurane DRUG

Sevoflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled sevoflurane will be adjusted to maintain the bispectral index (BIS) value between 40 and 60. Analgesia will be supplemented with 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. Sevoflurane inhalation will be stopped at the end of surgery.

Also known as: Sevoflurane for inhalation

Sevoflurane group

Propofol DRUG

Propofol will be administered by intravenous infusion for anesthesia maintenance. The infusion rate of propofol will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be supplemented with 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. Propofol infusion will be stopped at the end of surgery.

Also known as: Propofol for injection

Propofol group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Participants will be included if they meet all the following criteria:
• Age ≥ 65 years and \< 90 years;
• Primary malignant tumor;
• Do not receive radiation therapy or chemotherapy before surgery;
• Scheduled to undergo surgery for the treatment of tumors, with an expected duration of 2 hours or more, under general anesthesia;
• Agree to participate, and give signed written informed consent.

You may not qualify if:

• Patients will be excluded if they meet any of the following criteria:
• Preoperative history of schizophrenia, epilepsy, parkinsonism or myasthenia gravis;
• Inability to communicate in the preoperative period (coma, profound dementia, language barrier, or end-stage disease);
• Critical illness (preoperative American Society of Anesthesiologists physical status classification ≥ IV), severe hepatic dysfunction (Child-Pugh class C), or severe renal dysfunction (undergoing dialysis before surgery);
• Neurosurgery;
• Other reasons that are considered unsuitable for participation by the responsible surgeons or investigators (reasons must be recorded in the case report form).

Sponsors & Collaborators

• Peking University First Hospital: lead
• Hebei Medical University Fourth Hospital: collaborator
• The People's Hospital of Ningxia: collaborator
• Beijing Shijitan Hospital, Capital Medical University: collaborator
• Guizhou Provincial People's Hospital: collaborator
• Affiliated Hospital of Qinghai University: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• Cancer Hospital of Guangxi Medical University: collaborator
• Shanxi Provincial People's Hospital: collaborator
• Zhongda Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Tang-Du Hospital: collaborator
• Tianjin Nankai Hospital: collaborator
• Shenzhen Second People's Hospital: collaborator

Study Sites (17)

Peking University First Hospital

Beijing, Beijing Municipality, 10034, China

Location

Beijing Shijitan Hospital

Beijing, Beijing Municipality, China

Location

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Location

Peking University School and Hospital of Stomatology

Beijing, Beijing Municipality, China

Location

Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

Shenzhen Second People's Hospital

Shenzhen, Guangzhou, China

Location

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Location

Hebei Medical University Forth Hospital

Shijiazhuang, Hebei, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Zhongda Hospital

Nanjing, Jiangsu, China

Location

Ningxia People's Hospital

Yinchuan, Ningxia, China

Location

Affiliated Hospital of Qinghai University

Xining, Qinghai, China

Location

Tang-Du Hospital

Xi'an, Shaanxi, China

Location

Shaanxi Provincial People's Hospital

Taiyuan, Shanxi, China

Location

Shanxi Province Cancer Hospital

Taiyuan, Shanxi, China

Location

Tianjin Nankai Hospital

Tianjin, China

Location

Related Publications (9)

• Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.

  PMID: 18582931 BACKGROUND

• Nishikawa K, Nakayama M, Omote K, Namiki A. Recovery characteristics and post-operative delirium after long-duration laparoscope-assisted surgery in elderly patients: propofol-based vs. sevoflurane-based anesthesia. Acta Anaesthesiol Scand. 2004 Feb;48(2):162-8. doi: 10.1111/j.0001-5172.2004.00264.x.

  PMID: 14995937 BACKGROUND

• Schoen J, Husemann L, Tiemeyer C, Lueloh A, Sedemund-Adib B, Berger KU, Hueppe M, Heringlake M. Cognitive function after sevoflurane- vs propofol-based anaesthesia for on-pump cardiac surgery: a randomized controlled trial. Br J Anaesth. 2011 Jun;106(6):840-50. doi: 10.1093/bja/aer091. Epub 2011 Apr 25.

  PMID: 21518736 BACKGROUND

• Cai Y, Hu H, Liu P, Feng G, Dong W, Yu B, Zhu Y, Song J, Zhao M. Association between the apolipoprotein E4 and postoperative cognitive dysfunction in elderly patients undergoing intravenous anesthesia and inhalation anesthesia. Anesthesiology. 2012 Jan;116(1):84-93. doi: 10.1097/ALN.0b013e31823da7a2.

  PMID: 22108393 BACKGROUND

• Kalimeris K, Kouni S, Kostopanagiotou G, Nomikos T, Fragopoulou E, Kakisis J, Vasdekis S, Matsota P, Pandazi A. Cognitive function and oxidative stress after carotid endarterectomy: comparison of propofol to sevoflurane anesthesia. J Cardiothorac Vasc Anesth. 2013 Dec;27(6):1246-52. doi: 10.1053/j.jvca.2012.12.009. Epub 2013 May 30.

  PMID: 23725684 BACKGROUND

• Tang N, Ou C, Liu Y, Zuo Y, Bai Y. Effect of inhalational anaesthetic on postoperative cognitive dysfunction following radical rectal resection in elderly patients with mild cognitive impairment. J Int Med Res. 2014 Dec;42(6):1252-61. doi: 10.1177/0300060514549781. Epub 2014 Oct 22.

  PMID: 25339455 BACKGROUND

• Cao SJ, Zhang Y, Zhang YX, Zhao W, Pan LH, Sun XD, Jia Z, Ouyang W, Ye QS, Zhang FX, Guo YQ, Ai YQ, Zhao BJ, Yu JB, Liu ZH, Yin N, Li XY, Ma JH, Li HJ, Wang MR, Sessler DI, Ma D, Wang DX; First Study of Perioperative Organ Protection (SPOP1) investigators. Delirium in older patients given propofol or sevoflurane anaesthesia for major cancer surgery: a multicentre randomised trial. Br J Anaesth. 2023 Aug;131(2):253-265. doi: 10.1016/j.bja.2023.04.024. Epub 2023 Jun 4.

  PMID: 37474241 DERIVED

• Zhang Y, Shan GJ, Zhang YX, Cao SJ, Zhu SN, Li HJ, Ma D, Wang DX; First Study of Perioperative Organ Protection (SPOP1) Investigators. Preoperative vitamin D deficiency increases the risk of postoperative cognitive dysfunction: a predefined exploratory sub-analysis. Acta Anaesthesiol Scand. 2018 Aug;62(7):924-935. doi: 10.1111/aas.13116. Epub 2018 Mar 26.

  PMID: 29578249 DERIVED

• Zhang Y, Li HJ, Wang DX, Jia HQ, Sun XD, Pan LH, Ye QS, Ouyang W, Jia Z, Zhang FX, Guo YQ, Ai YQ, Zhao BJ, Yang XD, Zhang QG, Yin N, Tan HY, Liu ZH, Yu JB, Ma D. Impact of inhalational versus intravenous anaesthesia on early delirium and long-term survival in elderly patients after cancer surgery: study protocol of a multicentre, open-label, and randomised controlled trial. BMJ Open. 2017 Nov 28;7(11):e018607. doi: 10.1136/bmjopen-2017-018607.

  PMID: 29187413 DERIVED

MeSH Terms

Conditions

Delirium; Postoperative Complications; Postoperative Cognitive Complications; Neoplasms

Interventions

Sevoflurane; Inhalation; Propofol; Injections

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Cognitive Dysfunction; Cognition Disorders

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 25, 2016
• Study Start: April 1, 2015
• Primary Completion: September 29, 2017
• Study Completion: November 26, 2017
• Last Updated: March 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (17)