Desflurane and Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery

NCT ID: NCT04805775

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-21

Study Completion Date

2023-03-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Desflurane Propofol Postoperative Sleep PSQI Breast Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

Desflurane Inhalation

Intervention Type 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).

Propofol Group

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

Group Type ACTIVE_COMPARATOR

Desflurane Inhalation

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zhongnan Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39038404 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B076201420067

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

OFA in Thoracic Surgery
NCT05063396 RECRUITING NA