- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04541823
The Effect of Desflurane on Postopertative Cognitive Dysfunction
A Study Evaluating the Effect of Desflurane in Preventing Postoperative Cognitive Dysfunction
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100020
- Recruiting
- Beijing Chaoyang Hospital, Capital Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Desflurane
Patients allocated to this arm will receive desflurane during the maintenance of anesthesia.
|
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
|
Investigators administrated propofol with target of BIS 40-60 during the maintenance of anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of postoperative cognitive dysfunction
Time Frame: 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
|
on the 30th day after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of postoperative nausea and vomiting
Time Frame: Within 7 days after surgery
|
Within 7 days after surgery
|
|
Incidence of postoperative delirium
Time Frame: 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)
|
1-7days after surgery, on the 30th day after surgery
|
Postoperative Pain
Time Frame: 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.
|
Within 3 days after surgery
|
EEG frequency spectrum
Time Frame: 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:
|
5 minutes before anesthesia introduction to 5 minutes before discharge from PACU
|
Mortality
Time Frame: Within 30 days after surgery
|
Within 30 days after surgery
|
|
Length of Hospital stay
Time Frame: From the date of admission until discharged from hospital, within 30 days
|
From the date of admission until discharged from hospital, within 30 days
|
|
Hospital readmission
Time Frame: Within 30 days after surgery
|
Hospital readmission during the follow up
|
Within 30 days after surgery
|
Adverse events
Time Frame: Within 30 days after surgery
|
Other adverse events within 3 days after surgery were noted
|
Within 30 days after surgery
|
Neural and hemodynamic responses during desflurane general anesthesia
Time Frame: 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.
|
5 minutes before anesthesia introduction to 5 minutes after emergence
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Postoperative Complications
- Neurocognitive Disorders
- Cognition Disorders
- Cognitive Dysfunction
- Postoperative Cognitive Complications
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Hypnotics and Sedatives
- Anesthetics, Inhalation
- Propofol
- Desflurane
Other Study ID Numbers
- 00375928
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Delirium
-
Qin ZhangNational Natural Science Foundation of ChinaRecruiting
-
Qin ZhangNational Natural Science Foundation of ChinaRecruitingDelirium, PostoperativeChina
-
University Hospital, Basel, SwitzerlandInnosuisse - Swiss Innovation AgencyRecruitingPostoperative Delirium (POD)Switzerland
-
Konya City HospitalCompletedPREOPERATIVE SLEEP QUALITY ON POSTOPERATIVE DELIRIUMTurkey
-
University of VirginiaNational Institutes of Health (NIH); National Institute on Aging (NIA)RecruitingIdentify Postoperative Delirium Using Exhaled Gas PatternsUnited States
-
University Hospital, GhentCompletedPostoperative Pain | Postoperative DeliriumBelgium
-
Menoufia UniversityCompleted
-
Marmara UniversityActive, not recruitingPostoperative Delirium | Postoperative Nausea | Postoperative VomitingTurkey
-
Chinese PLA General HospitalBeijing Tiantan HospitalRecruiting
-
Charite University, Berlin, GermanyBARMERRecruitingDelirium in Old AgeGermany
Clinical Trials on Desflurane
-
Shengjing HospitalUnknownPostoperative Cognitive Dysfunction
-
Gangnam Severance HospitalRecruitingLumbar Fusion SurgeryKorea, Republic of
-
National Cancer Institute, EgyptEnrolling by invitation
-
Zhejiang Cancer HospitalCompletedHepatocellular Carcinoma | Circulating Tumor Cells | Desflurane Adverse Reaction | Propofol Adverse ReactionChina