RecruitingPhase 4NCT06778811

Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery


Sponsor

Nanjing First Hospital, Nanjing Medical University

Enrollment

180 participants

Start Date

Oct 11, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 75 Years

Inclusion Criteria2

  • ASA class II-III, NYHA class I-III, EF ≥ 50%
  • Intended to perform cardiac surgery under extracorporeal circulation

Exclusion Criteria7

  • Patients undergoing second heart surgery
  • Patients with mental retardation, deafness, or other conditions that interfere with normal communication
  • Previous neurological or psychiatric disorders
  • Patients with a history of sleep disorders
  • Alcoholics, drug addicts, or psychotropic substance abusers
  • Significant hepatic or renal dysfunction affecting drug metabolism
  • Contraindication to the use of dexmedetomidine or esketamine.

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Interventions

DRUGIntraoperative infusion of dexmedetomidine

Intraoperative infusion of 0.3ug/kg/h dexmedetomidine

DRUGIntraoperative infusion of esketamine

Intraoperative infusion of 0.3mg/kg/h esketamine

DRUGSaline control

Intraoperative infusion of equal volumes of saline


Locations(2)

Nanjing First Hospital,Nanjing Medical University

Nanjing, Jiangsu, China

Nanjing First Hospital

Nanjing, Jiangsu, China

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NCT06778811


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