Back to resultsThe Effect of Desflurane on Postopertative Cognitive Dysfunction
Primary Purpose
Postoperative Cognitive Dysfunction, Postoperative Delirium
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Desflurane
Propofol
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Cognitive Dysfunction
Eligibility Criteria
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.
Sites / Locations
- Beijing Chaoyang Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Desflurane
Propofol
Arm Description
Patients allocated to this arm will receive desflurane during the maintenance of anesthesia.
Patients allocated to this arm will receive propofol during the maintenance of anesthesia
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Incidence of postoperative delirium
Screening of the patients regarding a postoperative delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU)
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.
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)
Mortality
Length of Hospital stay
Hospital readmission
Hospital readmission during the follow up
Incidence of postoperative nausea and vomiting
Adverse events
Other adverse events within 3 days after surgery were noted
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.
Full Information
NCT ID
NCT04541823
First Posted
August 4, 2020
Last Updated
August 15, 2021
Sponsor
Beijing Chao Yang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04541823
Brief Title
The Effect of Desflurane on Postopertative Cognitive Dysfunction
Official Title
A Study Evaluating the Effect of Desflurane in Preventing Postoperative Cognitive Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction, Postoperative Delirium
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Desflurane
Arm Type
Experimental
Arm Description
Patients allocated to this arm will receive desflurane during the maintenance of anesthesia.
Arm Title
Propofol
Arm Type
Placebo Comparator
Arm Description
Patients allocated to this arm will receive propofol during the maintenance of anesthesia
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
Investigators administrated desflurane with target of BIS 40-60 during the maintenance of anesthesia
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Investigators administrated propofol with target of BIS 40-60 during the maintenance of anesthesia
Primary Outcome Measure Information:
Title
Incidence of postoperative cognitive dysfunction
Description
Screening of the patients regarding an postoperative cognitive dysfunction by TICS-M.TICS-M is assessed at 30 days after surgery
Time Frame
on the 30th day after surgery
Secondary Outcome Measure Information:
Title
Incidence of postoperative delirium
Description
Screening of the patients regarding a postoperative delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU)
Time Frame
1-7days after surgery, on the 30th day after surgery
Title
Postoperative Pain
Description
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.
Time Frame
Within 3 days after surgery
Title
EEG frequency spectrum
Description
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)
Time Frame
5 minutes before anesthesia introduction to 5 minutes before discharge from PACU
Title
Mortality
Time Frame
Within 30 days after surgery
Title
Length of Hospital stay
Time Frame
From the date of admission until discharged from hospital, within 30 days
Title
Hospital readmission
Description
Hospital readmission during the follow up
Time Frame
Within 30 days after surgery
Title
Incidence of postoperative nausea and vomiting
Time Frame
Within 7 days after surgery
Title
Adverse events
Description
Other adverse events within 3 days after surgery were noted
Time Frame
Within 30 days after surgery
Title
Neural and hemodynamic responses during desflurane general anesthesia
Description
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.
Time Frame
5 minutes before anesthesia introduction to 5 minutes after emergence
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Beijing Chaoyang Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anshi Wu, MD
Phone
+8685231330
Email
wuanshi1965@163.com
First Name & Middle Initial & Last Name & Degree
Anshi Wu, MD
12. IPD Sharing Statement
Learn more about this trial
The Effect of Desflurane on Postopertative Cognitive Dysfunction
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