Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery

Phase 4

Recruiting

• Conditions: Sleep Wake Disorders; Esketamine and the Quality of Recovery; Dexmedetomidine
• Interventions: Drug: Intraoperative infusion of dexmedetomidine; Drug: Intraoperative infusion of esketamine; Drug: Saline control

• Registration Number: NCT06778811
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-11
• Study First Submitted: 2024-12-23
• Study First Submitted QC: 2025-01-15
• Study First Posted: 2025-01-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexmedetomidine group	Intraoperative infusion of dexmedetomidine	Intraoperative infusion of 0.3ug/kg/h dexmedetomidine
esketamine group	Intraoperative infusion of esketamine	Intraoperative infusion of 0.3mg/kg/h esketamine
control group	Saline control	Intraoperative infusion of equal volumes of saline

Primary Outcome Measures

Name	Time	Method
Sleep Quality	1, 3, 7days after surgery	Assessment of sleep quality by the Athens Insomnia Scale (AIS) and smart wearable device

Secondary Outcome Measures

Name	Time	Method
postoperative pain	24 hours and 48 hours after surgery	Assessment of postoperative pain levels by Visual Analogue Scale（VAS），from 0 to 10, Higher scores mean more severe pain，VAS\>4 means positive.
Record postoperative analgesic medications used and the amount used for postoperative pain	24 hours and 48 hours after surgery	Record postoperative analgesic medications used and the amount used
anxiety and depression assessment	1,3 days after surgery	Assessment of anxiety and depression levels by Hospital anxiety and depression scale (HADS)，0-7 is negative; 8-10 is mild; 11-14 is moderate; 15-21 is severe.
Postoperative complications	48 hours after surgery	including nausea and vomiting, dizziness, itching, nightmares and so on.
Postoperative delirium	from 1 day to 7 days after surgery	Assessment of Postoperative delirium by Confusion Assessment Method (CAM)，scores \> 21 is positive.

Trial Locations

Locations (2)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China

Nanjing First Hospital，Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China