NCT06778811

Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Nanjing First Hospital, Nanjing Medical University · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-10-11
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2025-01-16
• Last updated: 2025-02-07

Locations

2 sites across 1 country: China