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Zhongnan Hospital of Wuhan University (ZhongnanH)

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ClinicalTrials.gov Identifier: NCT04805775
Recruitment Status : Not yet recruiting
First Posted : March 18, 2021
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
Zhongnan Hospital

Study Description
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Brief Summary:
To compare the effects of desflurane and propofol anesthesia on sleep quality of breast cancer patients after operation

Condition or disease Intervention/treatment Phase
Desflurane Propofol Postoperative Sleep PSQI Mammary Cancer Drug: Desflurane Inhalant Product Not Applicable

Detailed Description:
Objective to explore the relationship between anesthesia and postoperative sleep quality, and to observe whether desflurane anesthesia is not inferior to propofol anesthesia in patients undergoing elective radical mastectomy
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Zhongnan Hospital of Wuhan University
Estimated Study Start Date : March 15, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Desflurane Inhalant Product Group
Anesthesia maintenance: desflurane inhalation (mac1.0-1.2) sufentanil 0.3-0.5 μ g / (kg · h) atracurium CIS benzenesulfonate 1-3 μ g / (kg · min)
 Drug: Desflurane Inhalant Product
Objective To observe the effect of desflurane on postoperative sleep quality of patients undergoing elective radical mastectomy. Methods 124 patients undergoing elective radical mastectomy were randomly divided into two groups: Propofol group and desflurane group
Other Name: Propofol
Experimental: Propofol Group
Anesthesia maintenance: propofol TCI: 3-4ug / ml sufentanil 0.3-0.5 μ g / (kg · h) cisatracurium besylate 1-3 μ g / (kg · min)
 Drug: Desflurane Inhalant Product
Objective To observe the effect of desflurane on postoperative sleep quality of patients undergoing elective radical mastectomy. Methods 124 patients undergoing elective radical mastectomy were randomly divided into two groups: Propofol group and desflurane group
Other Name: Propofol


Outcome Measures
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Primary Outcome Measures :
  1. Pittsburgh sleep quality index [ Time Frame: propofol group and desflurane group 1-3 days after operation ]

Secondary Outcome Measures :
  1. Pittsburgh sleep quality index [ Time Frame: before operation, 4-7 days after operation and 1 month after operation ]
  2. Total sleep time (TST), rapid eye movement time (REM), wake-up time after sleep [ Time Frame: Before operation and within 1 week after operation ]
  3. Changes of functional connectivity (FC) and structural connectivity (SC) in resting state fMRI [ Time Frame: Before operation, 3 days after operation and 1 month after operation ]
  4. Depression Scale score [ Time Frame: Preoperative, postoperative 1-7 days, postoperative 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • （1）The operation time is 3-4 hours (2) Age 30-75 years old, BMI 18.5-25.0kg/m2, ASA grade I or II (3) There was no depression (MDI < 21) and cognitive impairment (MMSE ≥ 27) before operation (4) Those who voluntarily participate in the research and sign the informed consent

Exclusion Criteria:

  • (1) The patients received adjuvant chemotherapy before operation (2) At present, they are taking psychoactive, opioid, anti anxiety and hypnotic drugs (3) Known or treated patients with apnea syndrome (4) Patients with other cancers
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Zhongnan Hospital
ClinicalTrials.gov Identifier: NCT04805775    
Other Study ID Numbers: B076201420067
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Propofol
Desflurane
 Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Inhalation