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NCT Number: NCT06778811

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

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Key information

Conditions

Sleep Wake Disorders Dexmedetomidine Esketamine and the Quality of Recovery Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nanjing First Hospital, Nanjing, Jiangsu, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Intraoperative infusion of dexmedetomidine

Drug

Intraoperative infusion of 0.3ug/kg/h dexmedetomidine

Intraoperative infusion of esketamine

Drug

Intraoperative infusion of 0.3mg/kg/h esketamine

saline control

Drug

Intraoperative infusion of equal volumes of saline

Primary outcomes

  1. Sleep Quality

    Time frame: 1, 3, 7days after surgery

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

Secondary outcomes

  1. postoperative pain

    Time frame: 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.

  2. Record postoperative analgesic medications used and the amount used for postoperative pain

    Time frame: 24 hours and 48 hours after surgery

    Record postoperative analgesic medications used and the amount used

  3. anxiety and depression assessment

    Time frame: 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.

  4. Postoperative complications

    Time frame: 48 hours after surgery

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

  5. Postoperative delirium

    Time frame: from 1 day to 7 days after surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kuang xueyi

CONTACT

[email protected]

86+18651908072

hongwei shi

CONTACT

[email protected]

86+18951670892

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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