Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Sleep Wake Disorders; Dexmedetomidine; Esketamine and the Quality of Recovery
• Intervention / Treatment: Drug: Intraoperative infusion of dexmedetomidine; Drug: Intraoperative infusion of esketamine; Drug: Saline control

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kuang xueyi; Phone Number: 86+18651908072; Email: kxy809707496@126.com
• Study Contact Backup: Name: hongwei shi; Phone Number: 86+18951670892; Email: mdshw@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Recruiting
      • Nanjing First Hospital
      • Contact: zhang ying, Master degree; Phone Number: 86+15380998716; Email: 1070434273@qq.com
      • Contact: shi hong wei, Doctor degree
    • Nanjing, Jiangsu, China, 210006
      • Not yet recruiting
      • Nanjing First Hospital，Nanjing Medical University
      • Contact: kuang xueyi; Phone Number: 86+18651908072; Email: kxy809707496@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dexmedetomidine group; Intraoperative infusion of 0.3ug/kg/h dexmedetomidine	Drug: Intraoperative infusion of dexmedetomidine; Intraoperative infusion of 0.3ug/kg/h dexmedetomidine
Experimental: esketamine group; Intraoperative infusion of 0.3mg/kg/h esketamine	Drug: Intraoperative infusion of esketamine; Intraoperative infusion of 0.3mg/kg/h esketamine
Placebo Comparator: control group; Intraoperative infusion of equal volumes of saline	Drug: Saline control; Intraoperative infusion of equal volumes of saline

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	Assessment of postoperative pain levels by Visual Analogue Scale（VAS），from 0 to 10, Higher scores mean more severe pain，VAS>4 means positive.	24 hours and 48 hours after surgery
Record postoperative analgesic medications used and the amount used for postoperative pain	Record postoperative analgesic medications used and the amount used	24 hours and 48 hours after surgery
anxiety and depression assessment	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.	1,3 days after surgery
Postoperative complications	including nausea and vomiting, dizziness, itching, nightmares and so on.	48 hours after surgery
Postoperative delirium	Assessment of Postoperative delirium by Confusion Assessment Method (CAM)，scores > 21 is positive.	from 1 day to 7 days after surgery

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Parasomnias; Sleep Wake Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Psychotropic Drugs; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Antidepressive Agents; Esketamine; Dexmedetomidine
• Other Study ID Numbers: KY20240924-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No