Clinical Study of Perioperative Sleep Disorders in Cardiac Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-75
SponsorNanjing First Hospital, Nanjing Medical University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ASA class II-III, NYHA class I-III, EF ≥ 50%
Intended to perform cardiac surgery under extracorporeal circulation
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Intraoperative infusion of dexmedetomidine
DrugIntraoperative infusion of 0.3ug/kg/h dexmedetomidine
Intraoperative infusion of esketamine
DrugIntraoperative infusion of 0.3mg/kg/h esketamine
Saline control
DrugIntraoperative infusion of equal volumes of saline
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: dexmedetomidine groupExperimental treatment 1 intervention
Group B: esketamine groupExperimental treatment 1 intervention
Group C: control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sleep Quality
Assessment of sleep quality by the Athens Insomnia Scale (AIS) and smart wearable device
Time frame
1, 3, 7days after surgerySecondary outcomes
1
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 surgery2
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 surgery3
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 surgery4
Postoperative complications
including nausea and vomiting, dizziness, itching, nightmares and so on.
Time frame
48 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov