BridgeMD
New treatment option for Adults
Official title Dexmedetomidine-Esketamine Combination and Sleep Disturbances After Major Noncardiac Surgery
ClinicalTrials.gov ID: NCT06859892
What this study is testing
What is Dexmedetomidine-esketamine combination?
Dexmedetomidine-esketamine combination is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for adults.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Sleep disturbances are common early after major surgery, and are associated with delayed recovery. A previous study showed that dexmedetomidine-esketamine combination as a supplement to patient-controlled intravenous analgesia improved postoperative analgesia and subjective sleep quality in patients after scoliosis correction surgery.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Aged ≥18 years.
- Scheduled for major noncardiac surgery (≥60 minutes) under general anesthesia with an expected end of surgery no later than 18:00 pm.
- Required patient-controlled intravenous analgesia after surgery.
You likely can't join if
- Emergency surgery, transurethral surgery, organ transplantation.
- Pregnant or lactating women.
- Patients who need hypnotics for sleep disturbance or antidepressants for depression prior to surgery.
- History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis.
- Inability to communicate due to coma, severe dementia, or speech disorders, endured hypoxic encephalopathy or traumatic brain injury, or after...
- Comorbid with hyperthyroidism and pheochromocytoma.
See the full eligibility criteria
- Aged ≥18 years.
- Scheduled for major noncardiac surgery (≥60 minutes) under general anesthesia with an expected end of surgery no later than 18:00 pm.
- Required patient-controlled intravenous analgesia after surgery.
- Emergency surgery, transurethral surgery, organ transplantation.
- Pregnant or lactating women.
- Patients who need hypnotics for sleep disturbance or antidepressants for depression prior to surgery.
- History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis.
- Inability to communicate due to coma, severe dementia, or speech disorders, endured hypoxic encephalopathy or traumatic brain injury, or after neurosurgery.
- Comorbid with hyperthyroidism and pheochromocytoma.
- Preoperative left ventricular ejection fraction \<30%, sick sinus syndrome, severe sinus bradycardia (heart rate \<50 beats/min), atrioventricular block of degree II or higher without pacemaker implantation, or systolic...
- Diagnosed as sleep apnea, or judged to be at high risk of moderate-to-severe sleep apnea as assessed by STOP-Bang.
- Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (on dialysis), or ASA classification ≥IV.
- Hypersensitive to dexmedetomidine and/or esketamine.
- Other conditions that are deemed unsuitable for study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.