Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery
NCT ID: NCT06778811
Last Updated: 2025-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
180 participants
INTERVENTIONAL
2024-10-11
2025-09-30
Brief Summary
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Does dexmedetomidine or esketamine prevent the development of postoperative sleep disturbances? Which one works better? The researchers compared dexmedetomidine and esketamine with saline (a drug-free solvent) to see if dexmedetomidine and esketamine prevented the development of postoperative sleep disturbances.
Participants will:
1. Intraoperative continuous infusion of dexmedetomidine, esketamine or saline until the end of surgery
2. Postoperative sleep was assessed on the first and third postoperative days using a sleep rating scale
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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dexmedetomidine group
Intraoperative infusion of 0.3ug/kg/h dexmedetomidine
Intraoperative infusion of dexmedetomidine
Intraoperative infusion of 0.3ug/kg/h dexmedetomidine
esketamine group
Intraoperative infusion of 0.3mg/kg/h esketamine
Intraoperative infusion of esketamine
Intraoperative infusion of 0.3mg/kg/h esketamine
control group
Intraoperative infusion of equal volumes of saline
Saline control
Intraoperative infusion of equal volumes of saline
Interventions
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Intraoperative infusion of dexmedetomidine
Intraoperative infusion of 0.3ug/kg/h dexmedetomidine
Intraoperative infusion of esketamine
Intraoperative infusion of 0.3mg/kg/h esketamine
Saline control
Intraoperative infusion of equal volumes of saline
Eligibility Criteria
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Inclusion Criteria
2. Intended to perform cardiac surgery under extracorporeal circulation
Exclusion Criteria
2. Patients with mental retardation, deafness, or other conditions that interfere with normal communication
3. Previous neurological or psychiatric disorders
4. Patients with a history of sleep disorders
5. Alcoholics, drug addicts, or psychotropic substance abusers
6. Significant hepatic or renal dysfunction affecting drug metabolism
7. Contraindication to the use of dexmedetomidine or esketamine.
40 Years
75 Years
ALL
No
Sponsors
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Nanjing First Hospital, Nanjing Medical University
OTHER
Responsible Party
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Locations
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Nanjing First Hospital，Nanjing Medical University
Nanjing, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KY20240924-05
Identifier Type: -
Identifier Source: org_study_id
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