The Effect of Desflurane on Postopertative Cognitive Dysfunction

Postoperative Delirium Clinical Trial

Official title:

A Study Evaluating the Effect of Desflurane in Preventing Postoperative Cognitive Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04541823
• Other study ID #: 00375928
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2021
• Est. completion date: March 2023

Study information

• Verified date: August 2021
• Source: Beijing Chao Yang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Delirium
• Postoperative Cognitive Dysfunction
• Postoperative Delirium

Intervention

Drug:
• Des?urane
Investigators administrated desflurane with target of BIS 40-60 during the maintenance of anesthesia
• Propofol
Investigators administrated propofol with target of BIS 40-60 during the maintenance of anesthesia

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of postoperative delirium	Screening of the patients regarding a postoperative delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU)	1-7days after surgery, on the 30th day after surgery
Secondary	Postoperative Pain	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.	Within 3 days after surgery
Secondary	EEG frequency spectrum	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: Five minutes before anesthesia introduction; During the entire operation; At discharge from post-anesthesia care unit (PACU)	5 minutes before anesthesia introduction to 5 minutes before discharge from PACU
Secondary	Mortality		Within 30 days after surgery
Secondary	Length of Hospital stay		From the date of admission until discharged from hospital, within 30 days
Secondary	Hospital readmission	Hospital readmission during the follow up	Within 30 days after surgery
Secondary	Incidence of postoperative nausea and vomiting		Within 7 days after surgery
Secondary	Adverse events	Other adverse events within 3 days after surgery were noted	Within 30 days after surgery
Secondary	Neural and hemodynamic responses during desflurane general anesthesia	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.	5 minutes before anesthesia introduction to 5 minutes after emergence