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Desflurane and Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04805775
Enrollment
118
Registered
2021-03-18
Start date
2021-10-21
Completion date
2023-03-10
Last updated
2023-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Desflurane, Propofol, Postoperative Sleep, PSQI, Breast Tumor

Brief summary

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

Interventions

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).

Sponsors

Zhongnan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Pittsburgh sleep quality indexPostoperative 3rd day

Secondary

MeasureTime frameDescription
Pittsburgh sleep quality indexPostoperative 7th, and 30th days
Total sleep time (TST), Rapid eye movement time (REM), Wakefulness after sleep onset (WASO)Postoperative 1st, 2nd, and 3rd daysFitbit Charge 2™ objectively measured
Self-Rating Anxiety Scale ScoresPostoperative 3rd, 7th, and 30th days
Recovery time and quality (steward scores)Up to 2 hours after operation
Visual analogue scale scoresPostoperative 3rd, 7th and 30th days
Flurbiprofen dosePostoperative 1st, 2nd, and 3rd days
Self-Rating Depression Scale ScoresPostoperative 3rd, 7th and 30th days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026