Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
NCT06566482

Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia in Patients at High-risk of OSA

Led by Peking University First Hospital · Updated on 2024-09-25

100

Participants Needed

1

Research Sites

63 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Patients with obstructive sleep apnea (OSA) are at increased risk of developing sleep disturbances after surgery. Dexmedetomidine is a highly selective α2-adrenergic agonist with sedative, analgesic, and anxiolytic effects. Ketamine is a noncompetitive N-methyl-d-aspartate (NMDA) receptor antagonist. Esketamine is the S-enantiomer of racemic ketamine and twice as potent as racemic ketamine for analgesia. A recent trial showed that mini-dose esketamine-dexmedetomidine in combination with opioids improved analgesia and subjective sleep quality after scoliosis correction surgery. This trial is designed to test the hypothesis that mini-dose dexmedetomidine-esketamine supplemented analgesia may improve postoperative sleep quality in patients at high-risk of OSA.

CONDITIONS

Official Title

Mini-dose Dexmedetomidine-Esketamine Supplemented Analgesia in Patients at High-risk of OSA

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years but not older than 80 years
  • Diagnosed with obstructive sleep apnea or at moderate-to-high risk based on the STOP-Bang Questionnaire
  • Scheduled for thoracoscopic or laparoscopic surgery under general anesthesia lasting at least 1 hour
  • Requires patient-controlled intravenous analgesia after surgery
Not Eligible

You will not qualify if you...

  • Diagnosed with central sleep apnea syndrome
  • History of schizophrenia, epilepsy, Parkinson disease, or myasthenia gravis
  • Taking antipsychotic medications including antidepressants or anxiolytics
  • Unable to communicate before surgery due to coma, severe dementia, or deafness
  • History of drug or alcohol dependence or sedative/hypnotic therapy within 1 month before surgery
  • Contraindications to ketamine such as hyperthyroidism, pheochromocytoma, or glaucoma
  • Sick sinus syndrome, severe sinus bradycardia (<50 bpm), or second-degree or higher atrioventricular block without pacemaker
  • Contraindications to high-flow nasal cannula therapy such as mediastinal emphysema, shock, cerebrospinal fluid leakage, nasosinusitis, otitis media, or nasal septum deviation
  • Severe liver, kidney, or heart dysfunction or ASA classification IV or above
  • Expected ICU admission with tracheal intubation after surgery
  • Other conditions deemed unsuitable for study participation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Peking University First Hospital

Beijing, Beijing Municipality, China, 100034

Actively Recruiting

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Research Team

X

Xin-Quan Liang, M.D.

CONTACT

D

Dong-Xin Wang, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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