Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery

Last updated: February 5, 2025
Sponsor: Nanjing First Hospital, Nanjing Medical University
Overall Status: Active - Recruiting

Phase

4

Condition

Sleep Disorders

Treatment

Saline control

Intraoperative infusion of dexmedetomidine

Intraoperative infusion of esketamine

Clinical Study ID

NCT06778811
KY20240924-05
  • Ages 40-75
  • All Genders

Study Summary

The aim of this clinical trial is to understand the effects of dexmedetomidine and esketamine on postoperative sleep in patients undergoing cardiac surgery. The main questions it aims to answer are:

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ASA class II-III, NYHA class I-III, EF ≥ 50%

  2. Intended to perform cardiac surgery under extracorporeal circulation

Exclusion

Exclusion Criteria:

  1. Patients undergoing second heart surgery

  2. Patients with mental retardation, deafness, or other conditions that interfere withnormal 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.

Study Design

Total Participants: 180
Treatment Group(s): 3
Primary Treatment: Saline control
Phase: 4
Study Start date:
October 11, 2024
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Nanjing First Hospital

    Nanjing, Jiangsu 210006
    China

    Active - Recruiting

  • Nanjing First Hospital，Nanjing Medical University

    Nanjing, Jiangsu 210006
    China

    Site Not Available

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