Desflurane and Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery

NCT04805775 | Completed

• 1 other identifier: B076201420067
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Desflurane; Propofol; Postoperative Sleep; PSQI; Breast Tumor

Outcome Measures

Primary Outcomes (1)

• Pittsburgh sleep quality index

  Postoperative 3rd day

Secondary Outcomes (7)

• 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

• 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

Study Arms (2)

Desflurane Inhalation Group

EXPERIMENTAL

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

Propofol Group

ACTIVE COMPARATOR

Anesthesia maintenance: Propofol TCI: 3-4ug / ml Sufentanil 0.3-0.5 μg / (kg·h) Cisatracurium 1-3 μg / (kg·min)

Drug: Desflurane Inhalation

Interventions

Desflurane Inhalation DRUG

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).

Desflurane Inhalation Group; Propofol Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing elective breast surgery
• Age 18-75 years old
• ASA-PS grade I or II
• Those who voluntarily participate in the research and sign the informed consent

You may not qualify if:

• Cognitive impairment (MMSE \<27) before the operation
• The patients received adjuvant chemotherapy before the operation
• At present, they are taking psychoactive, opioid, anti-anxiety, and hypnotic drugs
• Known or treated patients with obstructive sleep apnea
• Patients with other cancers

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

Related Publications (1)

• Wang X, Xiong B, Wu T, Liu X, Li K, Wang S, Deng MG, Peng M. Effect of desflurane maintenance on postoperative sleep quality in patients undergoing elective breast surgery: A non-inferiority randomized controlled trial. Sleep Med. 2024 Sep;121:287-294. doi: 10.1016/j.sleep.2024.07.022. Epub 2024 Jul 17.

  PMID: 39038404 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 18, 2021
• Study Start: October 21, 2021
• Primary Completion: September 9, 2022
• Study Completion: March 10, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)