The Effect of Desflurane on Postopertative Cognitive Dysfunction

NCT04541823 | Unknown Phase 4

• 1 other identifier: 00375928
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of desflurane on postoperative cognitive dysfunction

Conditions

Postoperative Cognitive Dysfunction; Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative cognitive dysfunction

  Screening of the patients regarding an postoperative cognitive dysfunction by TICS-M.TICS-M is assessed at 30 days after surgery

  on the 30th day after surgery

Secondary Outcomes (9)

• Incidence of postoperative delirium

  1-7days after surgery, on the 30th day after surgery

• Postoperative Pain

  Within 3 days after surgery

• EEG frequency spectrum

  5 minutes before anesthesia introduction to 5 minutes before discharge from PACU

• Mortality

  Within 30 days after surgery

• Length of Hospital stay

  From the date of admission until discharged from hospital, within 30 days

Study Arms (2)

Desflurane

EXPERIMENTAL

Patients allocated to this arm will receive desflurane during the maintenance of anesthesia.

Drug: Desflurane

Propofol

PLACEBO COMPARATOR

Patients allocated to this arm will receive propofol during the maintenance of anesthesia

Drug: Propofol

Interventions

Desflurane DRUG

Investigators administrated desflurane with target of BIS 40-60 during the maintenance of anesthesia

Desflurane

Propofol DRUG

Investigators administrated propofol with target of BIS 40-60 during the maintenance of anesthesia

Propofol

Eligibility Criteria

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

You may qualify if:

• \. Written consent given
• \. Scheduled to undergo elective non-cardiac surgeries under general anesthesia
• \. ASA Physical Score I-III

You may not qualify if:

• \. Patients with a history of neurological disease, such as Alzheimer disease.
• \. Patients with a history of psychiatric disease
• \. Patients with a medication history of antipsychotic drugs.
• \. Unable to complete neuropsychological testing including patients with severe visual or hearing impairment.
• \. Patients with preoperative delirium.
• \. Patients who have severe adverse events, such as cardiac arrest.
• \. Patients who preoperative MMSE score are below 20;
• \. Patients who undergo second operation in a short period.

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Conditions

Postoperative Cognitive Complications; Emergence Delirium

Interventions

Propofol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: September 9, 2020
• Study Start: May 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

CN (1)