Dexmedetomidine and esketamine given around surgery to improve recovery after general anesthesia

Impact of Perioperative Dexmedetomidine and Esketamine on Postoperative Quality of Recovery in Patients Undergoing General Anesthesia and Surgery: A 2×2 Factorial Randomized Trial

This trial will test whether giving dexmedetomidine, esketamine, or both during the perioperative period helps adults recover better after surgery under general anesthesia.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 316 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University First Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07308756 on ClinicalTrials.gov

What this trial studies

This is a single-center, phase 4, randomized 2x2 factorial trial at Peking University First Hospital assigning adults undergoing general anesthesia to receive dexmedetomidine, esketamine, both, or placebo during the perioperative period. The primary outcome is patient-reported quality of recovery (QoR), a multidimensional measure including pain, sleep quality, cognitive function, and emotional stability, with additional measures such as opioid consumption and adverse events. Eligible participants are adults scheduled for surgeries of at least one hour who will use postoperative patient-controlled intravenous analgesia, while patients with significant cardiac conduction disease, severe organ dysfunction, intracranial disease, or certain neuropsychiatric disorders are excluded. The trial compares the independent and combined effects of the two drugs to see if either or both improve overall postoperative recovery.

Who should consider this trial

Good fit: Adults aged 18 or older scheduled for at least one-hour surgery under general anesthesia who will receive postoperative patient-controlled intravenous analgesia and can communicate preoperatively.

Not a fit: Patients with severe bradycardia or conduction blocks, significant liver or renal failure, intracranial tumors or neurosurgery, certain psychiatric or neurologic disorders, or those not requiring postoperative PCA are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could reduce postoperative pain and opioid use, improve sleep and overall recovery, and shorten hospital stays for surgical patients.

How similar studies have performed: Previous studies show perioperative dexmedetomidine or ketamine/esketamine can improve analgesia and sleep, but combining the two and measuring patient-reported quality of recovery is less well studied.

Eligibility criteria

Inclusion Criteria:

* Aged 18 years or over;
* Scheduled to undergo surgery under general anesthesia, with an expected surgical duration of at least 1 hour;
* Required patient-controlled intravenous analgesia after surgery.

Exclusion Criteria:

* Unable to communicate preoperatively due to visual, auditory, or verbal barriers or other reasons;
* Severe bradycardia (heart rate \<50 bpm), sick sinus syndrome, or grade 2 or higher atrioventricular block without pacemaker;
* History of hyperthyroidism or pheochromocytoma;
* History of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or intracranial hypertension;
* Intracranial tumor or neurosurgery;
* Severe liver dysfunction (Child-Pugh class C), renal failure (requiring renal replacement therapy), or American Society of Anesthesiologists class IV or higher;
* Enrolled in other clinical studies.

Where this trial is running

Beijing, Beijing Municipality

• Peking University First Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
• Study coordinator: Dong-Xin Wang, MD, PhD

Conditions: General Anesthesia, Surgery, Dexmedetomidine, Esketamine, Quality of Recovery, General anesthesia, Quality of recovery