Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery

Nanjing Medical University

Status and phase: Enrolling; Phase 4

Conditions: Esketamine and the Quality of Recovery; Dexmedetomidine; Sleep Wake Disorders

Treatments: Drug: Intraoperative infusion of esketamine; Drug: Saline control; Drug: Intraoperative infusion of dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06778811

KY20240924-05

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Patients undergoing second heart surgery
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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 3 patient groups, including a placebo group

dexmedetomidine group

Experimental group

Description:

Intraoperative infusion of 0.3ug/kg/h dexmedetomidine

Treatment:

Drug: Intraoperative infusion of dexmedetomidine

esketamine group

Experimental group

Description:

Intraoperative infusion of 0.3mg/kg/h esketamine

Treatment:

Drug: Intraoperative infusion of esketamine

control group

Placebo Comparator group

Description:

Intraoperative infusion of equal volumes of saline

Treatment:

Drug: Saline control