Desflurane and Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery

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

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

Conditions
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Desflurane, Propofol, Postoperative Sleep, PSQI, Breast Tumor

Intervention / Treatment
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* Drug: Desflurane Inhalation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desflurane Inhalation Group<br>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<br>* 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).<br>|
| Active Comparator: Propofol Group<br>Anesthesia maintenance: Propofol TCI: 3-4ug / ml Sufentanil 0.3-0.5 μg / (kg·h) Cisatracurium 1-3 μg / (kg·min) | Drug: Desflurane Inhalation<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |