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Completed

NCT Number: NCT04805775

Desflurane and Postoperative Sleep Quality in Patients Undergoing Elective Breast Surgery

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

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Key information

Conditions

Desflurane Breast Diseases Breast Neoplasms Breast Tumor Neoplasms Neoplasms by Site PSQI Postoperative Sleep Propofol Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Pittsburgh sleep quality index

    Time frame: Postoperative 3rd day

Secondary outcomes

  1. Pittsburgh sleep quality index

    Time frame: Postoperative 7th, and 30th days

  2. Total sleep time (TST), Rapid eye movement time (REM), Wakefulness after sleep onset (WASO)

    Time frame: Postoperative 1st, 2nd, and 3rd days

    Fitbit Charge 2™ objectively measured

  3. Self-Rating Anxiety Scale Scores

    Time frame: Postoperative 3rd, 7th, and 30th days

  4. Self-Rating Depression Scale Scores

    Time frame: Postoperative 3rd, 7th and 30th days

  5. Visual analogue scale scores

    Time frame: Postoperative 3rd, 7th and 30th days

  6. Flurbiprofen dose

    Time frame: Postoperative 1st, 2nd, and 3rd days

  7. Recovery time and quality (steward scores)

    Time frame: Up to 2 hours after operation

Sponsors and collaborators

Lead sponsor

Zhongnan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 18, 2021
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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