The Effect of Desflurane on Postopertative Cognitive Dysfunction

• Sponsor: Beijing Chao Yang Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04541823
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 22
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Cognitive Dysfunction; Postoperative Delirium	Drug: Desflurane; Drug: Propofol	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Study Evaluating the Effect of Desflurane in Preventing Postoperative Cognitive Dysfunction
• Actual Study Start Date: May 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Desflurane Patients allocated to this arm will receive desflurane during the maintenance of anesthesia.	Drug: Desflurane; Investigators administrated desflurane with target of BIS 40-60 during the maintenance of anesthesia
Placebo Comparator: Propofol Patients allocated to this arm will receive propofol during the maintenance of anesthesia	Drug: Propofol; Investigators administrated propofol with target of BIS 40-60 during the maintenance of anesthesia

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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.

3. 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: Five minutes before anesthesia introduction During the entire operation At discharge from post-anesthesia care unit (PACU)

4. Mortality [Within 30 days after surgery]

5. Length of Hospital stay [From the date of admission until discharged from hospital, within 30 days]

6. Hospital readmission [Within 30 days after surgery]

   Hospital readmission during the follow up

7. Incidence of postoperative nausea and vomiting [Within 7 days after surgery]

8. Adverse events [Within 30 days after surgery]

   Other adverse events within 3 days after surgery were noted

9. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Chaoyang Hospital, Capital Medical University	Beijing	Beijing	China	100020

Sponsors and Collaborators

• Beijing Chao Yang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anshi Wu, Head of Anesthesiology, Beijing Chao Yang Hospital
• ClinicalTrials.gov Identifier: NCT04541823
• Other Study ID Numbers: 00375928
• First Posted: Sep 9, 2020
• Last Update Posted: Aug 19, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Delirium; Postoperative Cognitive Complications; Cognitive Dysfunction; Propofol; Desflurane

Study Results

No Results Posted as of Aug 19, 2021