A Phase 4 interventional study of Dexmedetomidine and Esketamine in General Anesthesia, Surgery and Dexmedetomidine, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Peking University First Hospital · Phase 4, Interventional, and Prevention
For patients after surgery, quality of recovery has significant impacts on the prognosis, quality of life, and rational allocation of medical resources. Dexmedetomidine and esketamine have each been used during the perioperative period and improved postoperative analgesia and subjective sleep quality. This 2x2 factorial trial is designed to explore the effects of dexmedetomidine, esketamine, and their combination on the quality of recovery in patients recovering from surgery under general anesthesia.
Surgical operation is an important therapeutic modality for surgical patients; quality of postoperative recovery has significant impacts on the prognosis, quality of life, and rational allocation of medical resources. Postoperative recovery is a complex process involving return of patients from surgery to baseline physiological and psychological status. Traditional indicators evaluating postoperative recovery mainly focus on physiological markers, length of hospital stay (LOS), and incidences of adverse events and complications. Recently, the quality of recovery (QoR) is increasingly used. QoR is subjectively reported by patients and includes multidimensional assessments on postoperative pain, cognitive function, sleep quality, and emotional stability.
Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, has anxiolytic, sedative, and analgesic effects. By activing α2-adrenergic receptors in the locus coeruleus, it activates the endogenous sleep pathways, and produce a state mimicking non-rapid eye movement (NREM) sleep. Clinical studies showed that perioperative use of low-dose dexmedetomidine improves sleep architecture, increases sleep efficiency, and prolongs total sleep time in non-mechanically ventilated patients. Furthermore, when used as an analgesic adjuvant, dexmedetomidine improves analgesia, reduces opioid consumption, and reduces opioid-related adverse events.
Ketamine, a non-competitive N-Methyl-D-aspartic (NMDA) receptor antagonist, exerts analgesic and anti-hyperalgesic effects by reducing transmission of noxious stimuli to the spinal cord. It is characterized by minimal respiratory and circulatory depression and excellent analgesic efficacy. In recent years, multiple studies confirmed that ketamine has antidepressant properties. Ketamine is a racemic mixture composed of S-ketamine (esketamine) and R-ketamine. Esketamine exhibits a stronger affinity for the NMDA receptor, with an effect approximately twice that of racemic ketamine. In clinical practice, esketamine has stronger analgesic effects and a lower incidence of adverse psychomimetic reactions. When used in combination with opioids, esketamine improved postoperative analgesia.
Previous studies showed that combined use of dexmedetomidine and esketamine might produce synergetic effects in improving sedation and analgesia. A recent trial found that low-dose dexmedetomidine-esketamine combination improved pain relief and subjective sleep quality in patients after scoliosis corrective surgery, without increasing side effects. It is therefore hypothesized that co-administration of dexmedetomidine and esketamine may enhance efficacy and optimize the quality of postoperative recovery. This 2x2 factorial trial is designed to explore the effects of dexmedetomidine, esketamine, and their combination on the quality of recovery in patients recovering from surgery under general anesthesia.
Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A loading dose of dexmedetomidine (0.2 ug/kg) is administered after anesthesia induction, followed by a continuous infusion of dexmedetomidineat a rate of 0.2 ug/kg/h until 30 minutes before the end of surgery. Self-controlled analgesia is established with dexmedetomidine 100 ug and sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours.
Drug: Dexmedetomidine
A loading dose of esketamine (0.1 mg/kg) is administered after anesthesia induction, followed by a continuous infusion of esketamineat a rate of 0.1 mg/kg/h until 30 minutes before the end of surgery. Self-controlled analgesia is established with esketamine 50 mg and sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours.
Drug: Esketamine
A loading dose of dexmedetomidine (0.2 ug/kg) and esketamine (0.1 mg/kg) is administered after anesthesia induction, followed by a continuous infusion of dexmedetomidine at a rate of 0.2 ug/kg/h and esketamine at a rate of 0.1 mg/kg/h until 30 minutes before the end of surgery. Self-controlled analgesia is established with dexmedetomidine 100 ug, esketamine 50 mg, and sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours.
Drug: Dexmedetomidine-esketamine
A loading dose of placebo (normal saline) is administered after anesthesia induction, followed by a continuous infusion of placebo at a rate same as above until 30 minutes before the end of surgery. Self-controlled analgesia is established with sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours.
Drug: Placebo
A loading dose of dexmedetomidine (0.2 ug/kg) is administered after anesthesia induction, followed by a continuous infusion of dexmedetomidineat a rate of 0.2 ug/kg/h until 30 minutes before the end of surgery. Self-controlled analgesia is established with dexmedetomidine 100 ug and sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours.
A loading dose of esketamine (0.1 mg/kg) is administered after anesthesia induction, followed by a continuous infusion of esketamineat a rate of 0.1 mg/kg/h until 30 minutes before the end of surgery. Self-controlled analgesia is established with esketamine 50 mg and sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours.
A loading dose of dexmedetomidine (0.2 ug/kg) and esketamine (0.1 mg/kg) is administered after anesthesia induction, followed by a continuous infusion of dexmedetomidine at a rate of 0.2 ug/kg/h and esketamine at a rate of 0.1 mg/kg/h until 30 minutes before the end of surgery. Self-controlled analgesia is established with dexmedetomidine 100 ug, esketamine 50 mg, and sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours.
A loading dose of placebo (normal saline) is administered after anesthesia induction, followed by a continuous infusion of placebo at a rate same as above until 30 minutes before the end of surgery. Self-controlled analgesia is established with sufentanil 100 ug, diluated with normal saline to 100 ml, and programmed to deliver 2-ml boluses with a lock-out interval of 10 minutes and a background infusion rate at 1 ml/h for a duration of 48 hours.
Quality of recovery-15 (QoR-15) score
A 15-item scale that evaluate quality of recovery in five dimensions: pain, physiological comfort, physiological independence, psychological support, and emotional state. Scores range from 0 to 150 , with higher scores indicating better recovery quality.
Time frame: At 24 hours after surgery
Quality of recovery-15 (QoR-15) score
QoR is a 15-item scale that evaluate quality of recovery in five dimensions: pain, physiological comfort, physiological independence, psychological support, and emotional state. Scores range from 0 to 150 , with higher scores indicating better recovery quality.
Time frame: At 72 hours after surgery
Postoperative delirium (POD) within 4 days
Delirium will be assessed twice daily (8:00-10:00 and 18:00-20:00) using the 3-minute diagnostic interview for confusion assessment method-defined delirium (3D-CAM) or the confusion assessment method for the intensive care unit (CAM-ICU).
Time frame: Up to 4 days after surgery
Incidence of delayed neurocognitive recovery at 5 days
Cognitive function will be assessed with the telephone-administered Montreal Cognitive Assessment (T-MoCA) at baseline and at 5 days or before hospital discharge after surgery. A decline of T-MoCA score of 1 standard deviation (SD) or more from baseline is defined as delayed neurocognitive recovery.
Time frame: Up to 5 days after surgery
Area under curve of pain intensity after surgery
Pain intensity will be assessed at 1 hour and then twice daily (8:00-10:00 and 18:00-20:00) after surgery using the numeric rating scale (an 11-point scale where 0=no pain and 10=the worst pain).
Time frame: Up to 4 days after surgery
Cumulative subjective sleep quality score after surgery
Subjective sleep quality will be assessed once daily (8:00-10:00) after surgery using the numeric rating scale (an 11-point scale where 0=the best sleep and 10=the worst sleep).
Time frame: Up to 4 days after surgery
Length of hospital stay after surgery
Length of hospital stay after surgery.
Time frame: Up to 30 days after surgery
Incidence of postoperative complications within 30 days
Postoperative complications are generally defined as new-onset medical conditions that are deemed harmful and required therapeutic intervention, i.e., grade 2 or higher on the Clavien-Dindo classification.
Time frame: Up to 30 days after surgery
All-cause 30-day mortality
All-cause 30-day mortality
Time frame: Up to 30 days after surgery
Incidence of delayed neurocognitive recovery at 30 days
Cognitive function will be assessed with the telephone-administered Montreal Cognitive Assessment (T-MoCA) at baseline and at 30 days after surgery. A decline of T-MoCA score of 1 standard deviation (SD) or more from baseline is defined as delayed neurocognitive recovery.
Time frame: At 30 days after surgery
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peking University First Hospital