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Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery

NCT06778811 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-02-07

No results posted yet for this study

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

Conditions

  • Sleep Wake Disorders
  • Esketamine and the Quality of Recovery
  • Dexmedetomidine

Interventions

DRUG

Intraoperative infusion of dexmedetomidine

Intraoperative infusion of 0.3ug/kg/h dexmedetomidine

DRUG

Intraoperative infusion of esketamine

Intraoperative infusion of 0.3mg/kg/h esketamine

DRUG

Saline control

Intraoperative infusion of equal volumes of saline

Sponsors & Collaborators

  • Nanjing First Hospital, Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-11
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06778811 on ClinicalTrials.gov