Desflurane and Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery

Propofol Clinical Trial

Official title:

Effect of Desflurane on Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery: A Non-inferiority Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04805775
• Other study ID #: B076201420067
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Breast Neoplasms
• Breast Tumor
• Desflurane
• Postoperative Sleep
• Propofol
• PSQI

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