The Effect of Desflurane on Postopertative Cognitive Dysfunction

Phase 4

• Conditions: Postoperative Cognitive Dysfunction; Postoperative Delirium
• Interventions: Drug: Desflurane; Drug: Propofol

• Registration Number: NCT04541823
• Lead Sponsor: Beijing Chao Yang Hospital

Brief Summary

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

Detailed Description

Postoperative cognitive dysfunction is a common complication during postoperative period，especially in elderly patients. It is characterized by cognitive decline, inattention and abnormal mental status following surgery. The presence of postoperative cognitive dysfunction is independently associated with poor recovery, increased hospital length of stay and increased mortality.

Desflurane is a widely used volatile anesthetic, associated with shorter emergence times than other volatile anesthetics. This study aims to access the effect of desflurane in preventing postoperative cognitive dysfunction.

Study Timeline

• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-09
• Study Start: 2021-05-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-15
• Last Update Posted: 2021-08-19
• Primary Completion: 2022-12
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desflurane	Desflurane	Patients allocated to this arm will receive desflurane during the maintenance of anesthesia.
Propofol	Propofol	Patients allocated to this arm will receive propofol during the maintenance of anesthesia

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative cognitive dysfunction	on the 30th day after surgery	Screening of the patients regarding an postoperative cognitive dysfunction by TICS-M.TICS-M is assessed at 30 days after surgery

Secondary Outcome Measures

Name	Time	Method
Length of Hospital stay	From the date of admission until discharged from hospital, within 30 days
Neural and hemodynamic responses during desflurane general anesthesia	5 minutes before anesthesia introduction to 5 minutes after emergence	Functional near-infrared spectroscopy (fNIRS) will be monitored from pre-anesthesia to the emergence. △\[HbO\] ，△\[Hb\] will be recorded. Besides, the coupling of fNIRS signals with neuronal signals (EEG) will be calculated. Furthermore, sample entrophy and the phase difference between △\[HbO\] and △\[Hb\] will be measured.
Adverse events	Within 30 days after surgery	Other adverse events within 3 days after surgery were noted
Incidence of postoperative nausea and vomiting	Within 7 days after surgery
EEG frequency spectrum	5 minutes before anesthesia introduction to 5 minutes before discharge from PACU	Electroencephalography will be recorded at different points of time as follows and EEG characteristics including power in alpha, beta, theta, delta, gamma, spectrum will be extracted using MATLAB: 1. Five minutes before anesthesia introduction; 2. During the entire operation; 3. At discharge from post-anesthesia care unit (PACU)
Incidence of postoperative delirium	1-7days after surgery, on the 30th day after surgery	Screening of the patients regarding a postoperative delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU)
Mortality	Within 30 days after surgery
Hospital readmission	Within 30 days after surgery	Hospital readmission during the follow up
Postoperative Pain	Within 3 days after surgery	Visual Analogue Scale will be used to assess postoperative pain of patients. Numerical rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain.

Trial Locations

Locations (1)

Beijing Chaoyang Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China