Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery

Phase 4RecruitingNCT06778811

Nanjing First Hospital, Nanjing Medical University180 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

180

Conditions

Sleep Wake Disorders Esketamine and the Quality of Recovery Dexmedetomidine

Intraoperative infusion of dexmedetomidineDRUG

Intraoperative infusion of 0.3ug/kg/h dexmedetomidine

Intraoperative infusion of esketamineDRUG

Intraoperative infusion of 0.3mg/kg/h esketamine

Saline controlDRUG

Intraoperative infusion of equal volumes of saline

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Sleep Quality

Assessment of sleep quality by the Athens Insomnia Scale (AIS) and smart wearable device

Time frame: 1, 3, 7days after surgery

Secondary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 1,3 days after surgery

Postoperative complications

including nausea and vomiting, dizziness, itching, nightmares and so on.

Time frame: 48 hours after surgery

Postoperative delirium

Assessment of Postoperative delirium by Confusion Assessment Method (CAM)，scores \> 21 is positive.

Time frame: from 1 day to 7 days after surgery