Impact of Desflurane and Sevoflurane on Postoperative Delirium in Elderly Patients

NCT06176144 | Recruiting DMC

• 1 other identifier: Approval-No: 2023/1347
• Study Type: interventional
• Target: 890
• Locations: 1 country
• Sites: 1

Brief Summary

Advanced age is a consistent risk factor for the incidence of postoperative cognitive decline, which is associated with longer hospital stays, decreased quality of life, and increased mortality. Anaesthetic drugs can also affect postoperative cognition, as their residual effects can alter central nervous system activity. Desflurane and sevoflurane are widely used volatile anesthetics. Choice anesthetics may influence the occurrence of postoperative delirium. However, evidence in this aspect is conflicting.

Conditions

Delirium; Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• postoperative delirium

  Delirium is assessed twice daily 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.

  within 7 days after surgery

Secondary Outcomes (8)

• Quality of recovery, QoR15 (Quality of Recovery 15)

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

• Subjective sleep quality (NRS) within 3 days after surgery.

  Up to 3 days after surgery

• Length of stay in hospital after surgery.

  Up to 30 days after surgery

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

  Within 24 hours after surgery

• Length of stay in ICU after surgery.

  Up to 30 days after surgery

Other Outcomes (3)

• Cognitive function at 30 days after surgery

  On the 30th day after surgery

• TNF-α concentration

  The day before surgery and 24 hours after surgery. Performed in part of enrolled patients.

• IL-6 concentration

  The day before surgery and 24 hours after surgery. Performed in part of enrolled patients.

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, sufentanil. Sevoflurane inhalation will be stopped at the end of surgery.

Drug: Sevoflurane

Desflurane group

EXPERIMENTAL

Desflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled sevoflurane will be adjusted to maintain the BIS value between 40 and 60. Analgesia will be supplemented with remifentanil, sufentanil. Desflurane inhalation will be stopped at the end of surgery.

Drug: Desflurane

Interventions

Desflurane DRUG

Desflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled desflurane will be adjusted to maintain the bispectral index (BIS) value between 40 and 60. Analgesia will be supplemented with remifentanil (administered by continuous infusion), and sufentanil (administered by intermittent injection).Towards the end of surgery, desflurane inhalational concentration will be decreased and sufentanil will be administered when necessary. Desflurane inhalation will be stopped at the end of surgery.

Desflurane group

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).Towards the end of surgery, sevoflurane inhalational concentration will be decreased and sufentanil will be administered when necessary. Sevoflurane inhalation will be stopped at the end of surgery.

Sevoflurane group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years and \< 90 years;
• Scheduled to undergo non-cardiac or non-neurosurgery 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:

• Preoperative history of schizophrenia, epilepsy, parkinsonism or any diseases of central nervous system;
• Inability to communicate in the preoperative period (coma, dementia, language barrier, impaired hearing or vision);
• Severe diseases in cardiovascular, respiratory, liver, kidney, or preoperative American Society of Anesthesiologists physical status classification ≥ IV;
• Alcoholism and drug dependence;
• 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

• West China Hospital: lead

Study Sites (1)

Department of Anesthesiology, West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Delirium; Postoperative Cognitive Complications

Interventions

Desflurane; Sevoflurane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Jing Yang, MD,PhD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Yang, MD,PhD

CONTACT

+86- 18980602269; yangjing@wchscu.cn

Min Xu

CONTACT

+86-13281155917; 18706782887@163.com

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: Attending anesthesiologist，Department of Anesthesiology, West China Hospital, Sichuan University

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 19, 2023
• Study Start: September 10, 2023
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

CN (1)