NCT06778811

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. 1.Intraoperative continuous infusion of dexmedetomidine, esketamine or saline until the end of surgery
  2. 2.Postoperative sleep was assessed on the first and third postoperative days using a sleep rating scale

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2024

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

December 23, 2024

Last Update Submit

February 5, 2025

Conditions

Sleep Wake DisordersEsketamine and the Quality of RecoveryDexmedetomidine

Outcome Measures

Primary Outcomes (1)

  • Sleep Quality

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

    1, 3, 7days after surgery

Secondary Outcomes (5)

  • postoperative pain

    24 hours and 48 hours after surgery

  • Record postoperative analgesic medications used and the amount used for postoperative pain

    24 hours and 48 hours after surgery

  • anxiety and depression assessment

    1,3 days after surgery

  • Postoperative complications

    48 hours after surgery

  • Postoperative delirium

    from 1 day to 7 days after surgery

Study Arms (3)

dexmedetomidine group

EXPERIMENTAL

Intraoperative infusion of 0.3ug/kg/h dexmedetomidine

Drug: Intraoperative infusion of dexmedetomidine

esketamine group

EXPERIMENTAL

Intraoperative infusion of 0.3mg/kg/h esketamine

Drug: Intraoperative infusion of esketamine

control group

PLACEBO COMPARATOR

Intraoperative infusion of equal volumes of saline

Drug: Saline control

Interventions

Intraoperative infusion of dexmedetomidineDRUG

Intraoperative infusion of 0.3ug/kg/h dexmedetomidine

dexmedetomidine group
Intraoperative infusion of esketamineDRUG

Intraoperative infusion of 0.3mg/kg/h esketamine

esketamine group
Saline controlDRUG

Intraoperative infusion of equal volumes of saline

control group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients undergoing second heart surgery
  • Patients with mental retardation, deafness, or other conditions that interfere with normal communication
  • Previous neurological or psychiatric disorders
  • Patients with a history of sleep disorders
  • Alcoholics, drug addicts, or psychotropic substance abusers
  • Significant hepatic or renal dysfunction affecting drug metabolism
  • Contraindication to the use of dexmedetomidine or esketamine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nanjing First Hospital，Nanjing Medical University

Nanjing, Jiangsu, 210006, China

NOT YET RECRUITING

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Kuang xueyi

CONTACT

86+18651908072kxy809707496@126.com

hongwei shi

CONTACT

86+18951670892mdshw@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2024

First Posted

January 16, 2025

Study Start

October 11, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

February 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)