Impact of Perioperative Dexmedetomidine and Esketamine on Postoperative Quality of Recovery

ConditionsGeneral Anesthesia Surgery Dexmedetomidine Esketamine Quality of Recovery

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorPeking University First Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Factorial

Treatments tested in this trial

Dexmedetomidine
Drug
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.
Esketamine
Drug
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.
Dexmedetomidine-esketamine
Drug
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.
Placebo
Drug
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.

Treatment groups

316 Participants

are divided into 4 treatment groups

Group A: DexmedetomidineExperimental treatment 1 intervention

Group B: EsketamineExperimental treatment 1 intervention

Group C: Dexmedetomidine-esketamineExperimental treatment 1 intervention

Group D: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University First Hospital

Lead sponsor

Source ClinicalTrials.gov

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