Clinical trial

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

Name

B076201420067

Description

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

Trial arms

Trial start

2021-10-21

Estimated PCD

2022-09-09

Trial end

2023-03-10

Status

Completed

Treatment

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).

Arms:

Desflurane Inhalation Group, Propofol Group

Size

118

Primary endpoint

Pittsburgh sleep quality index

Postoperative 3rd day

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 118, 'type': 'ACTUAL'}}

Updated at

2023-05-31

1 organization

1 product

5 indications

Organization

Product

Indication

Indication

Indication

Indication

Indication