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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04805775
Other study ID # B076201420067
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 21, 2021
Est. completion date March 10, 2023

Study information

Verified date April 2023
Source Zhongnan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study intends to investigate the effects of desflurane on postoperative sleep quality to guide perioperative patient management.


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date March 10, 2023
Est. primary completion date September 9, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Undergoing elective breast surgery 2. Age 18-75 years old 3. ASA-PS grade I or II 4. Those who voluntarily participate in the research and sign the informed consent Exclusion Criteria: 1. Cognitive impairment (MMSE <27) before the operation 2. The patients received adjuvant chemotherapy before the operation 3. At present, they are taking psychoactive, opioid, anti-anxiety, and hypnotic drugs 4. Known or treated patients with obstructive sleep apnea 5. Patients with other cancers

Study Design


Intervention

Drug:
Desflurane Inhalation
Subjects were randomized in a 1:1 ratio to undergo breast surgery under maintenance of anesthesia with the classical intravenous anesthetic drug propofol (reference group) or the inhaled anesthetic drug desflurane (test group).

Locations

Country Name City State
China Zhongnan Hospital of Wuhan University Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pittsburgh sleep quality index Postoperative 3rd day
Secondary Pittsburgh sleep quality index Postoperative 7th, and 30th days
Secondary Total sleep time (TST), Rapid eye movement time (REM), Wakefulness after sleep onset (WASO) Fitbit Charge 2™ objectively measured Postoperative 1st, 2nd, and 3rd days
Secondary Self-Rating Anxiety Scale Scores Postoperative 3rd, 7th, and 30th days
Secondary Self-Rating Depression Scale Scores Postoperative 3rd, 7th and 30th days
Secondary Visual analogue scale scores Postoperative 3rd, 7th and 30th days
Secondary Flurbiprofen dose Postoperative 1st, 2nd, and 3rd days
Secondary Recovery time and quality (steward scores) Up to 2 hours after operation
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