Desflurane and Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery

Not Applicable

Completed

• Conditions: Desflurane; Postoperative Sleep; Breast Tumor; Propofol; PSQI
• Interventions: Drug: Desflurane Inhalation

• Registration Number: NCT04805775
• Lead Sponsor: Zhongnan Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-18
• Study Start: 2021-10-21
• Primary Completion: 2022-09-09
• Study Completion: 2023-03-10
• Status Verified: 2023-04
• Last Update Submitted: 2023-05-28
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 118

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desflurane Inhalation Group	Desflurane Inhalation	Anesthesia maintenance: Desflurane inhalation (MAC 1.0-1.2) Sufentanil 0.3-0.5 μg / (kg·h) Cisatracurium 1-3 μg / (kg·min)
Propofol Group	Desflurane Inhalation	Anesthesia maintenance: Propofol TCI: 3-4ug / ml Sufentanil 0.3-0.5 μg / (kg·h) Cisatracurium 1-3 μg / (kg·min)

Primary Outcome Measures

Name	Time	Method
Pittsburgh sleep quality index	Postoperative 3rd day

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China