Desflurane and Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery (ZhongnanH)

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

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

Study Overview

• Status: Completed
• Conditions: Desflurane; Propofol; Breast Tumor; Postoperative Sleep; PSQI
• Intervention / Treatment: Drug: Desflurane Inhalation

Detailed Description

Objective to explore the relationship between anesthesia and postoperative sleep quality, and to observe whether desflurane anesthesia is not inferior to propofol anesthesia in patients undergoing elective radical mastectomy

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430071
      • Zhongnan Hospital of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Desflurane Inhalation Group; Anesthesia maintenance: Desflurane inhalation (MAC 1.0-1.2) Sufentanil 0.3-0.5 μg / (kg·h) Cisatracurium 1-3 μg / (kg·min)	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).
Active Comparator: Propofol Group; Anesthesia maintenance: Propofol TCI: 3-4ug / ml Sufentanil 0.3-0.5 μg / (kg·h) Cisatracurium 1-3 μg / (kg·min)	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pittsburgh sleep quality index	Postoperative 3rd day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh sleep quality index		Postoperative 7th, and 30th days
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
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

Collaborators and Investigators

• Sponsor: Zhongnan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Actual): September 9, 2022
• Study Completion (Actual): March 10, 2023

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Anesthetics, Inhalation; Desflurane
• Other Study ID Numbers: B076201420067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No