Low-dose S-ketamine and Dexmedetomidine in Combination With Opioids for Postoperative Analgesia

NCT04791059 | Completed Phase 4 DMC

• 1 other identifier: 2020-465
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Scoliosis correction surgery is followed with severe pain. Patients after scoliosis correction surgery usually require high dose opioids and long duration analgesia, which may increase side effects and even drug tolerance. S-ketamine is the pure dextrorotatory enantiomer of ketamine with stronger analgesic effect and less side effects, but mental side effects is a major concern. Dexmedetomidine can be used as an analgesic supplement; it also improves sleep quality in postoperative patients. We hypothesize that low-dose ketamine and dexmedetomidine in combination with opioids may have synergistic effect in analgesia and reduce drug-related side effects. This study aims to explore the effect of low-dose of S-ketamine and dexmedetomidine in combination with opioids for postoperative patient-controlled intravenous analgesia in patients following scoliosis correction surgery.

Conditions

Scoliosis Correction; Postoperative Analgesia; S-ketamine; Dexmedetomidine; Sufentanil

Keywords

Scoliosis correction; Postoperative analgesia; S-ketamine; Dexmedetomidine; Sufentanil

Outcome Measures

Primary Outcomes (1)

• Percent of patients with moderate to severe pain within 72 hours

  Pain severity is evaluated with the Numeric Rating Scale (NRS, an 11-point scale where 0 = no pain and 10 = the worst pain) twice daily (8:00-10:00 and 18:00-20:00) at rest and with movement. Moderate to severe pain is defined as any NRS pain score of 4 or higher.

  Up to 72 hours after surgery

Secondary Outcomes (9)

• NRS pain score (at rest and with movement) at various timepoints after surgery

  Up to 72 hours after surgery

• Cumulative opioid consumption

  Up to 72 hours after surgery

• Cumulative analgesic consumption

  Up to 72 hours after surgery

• Agitation and sedation score at various timepoints after surgery

  Up to the 5th day after surgery

• Incidence of postoperative delirium within the first 5 days

  Up to the 5th day after surgery

Study Arms (2)

Combined analgesia group

EXPERIMENTAL

Patient-controlled analgesia is established with S-ketamine 50 mg, dexmedetomidine 200 microgram, and sufentanil 4 microgram/kg (maximum 250 microgram), diluted with normal saline to 200 ml, and programmed to administer 2-ml boluses with a lock-out interval of 8 minutes and a background infusion rate at 1 ml/h.

Drug: S-ketamine; Drug: Dexmedetomidine; Drug: Sufentanil

Control group

PLACEBO COMPARATOR

Patient-controlled analgesia is established with sufentanil 4 microgram/kg (maximum 250 microgram), diluted with normal saline to 200 ml, and programmed to administer 2-ml boluses with a lock-out interval of 8 minutes and a background infusion rate at 1 ml/h.

Drug: Sufentanil

Interventions

S-ketamine DRUG

S-ketamine 50 mg is included in the mixture for patient-controlled analgesia.

Combined analgesia group

Dexmedetomidine DRUG

Dexmedetomidine 200 microgram is included in the mixture for patient-controlled analgesia.

Combined analgesia group

Sufentanil DRUG

Sufentanil 4 microgram/kg (maximum 250 microgram) is included in the mixture for patient-controlled analgesia.

Combined analgesia group; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, body weight ≥ 40 kg;
• Scheduled to undergo scoliosis correction with pedicle screw fixation;
• Planned to use patient-controlled intravenous analgesia after surgery.

You may not qualify if:

• Refused to participate in the study;
• Preoperative sick sinus syndrome, severe sinus bradycardia (heart rate \< 50 beats/min), atrioventricular block grade II or above without pacemaker; or comorbid with congenital heart disease, arrhythmia, or other serious cardiovascular diseases with a cardiac function grade ≥ III;
• Patients with obstructive sleep apnea syndrome, or a STOP-Bang score ≥ 3 in combination with a serum HCO3- level ≥ 28 mmol/L;
• History of hyperthyroidism and pheochromocytoma;
• History of schizophrenia, epilepsy, myasthenia gravis, or delirium;
• Severe liver dysfunction (child Pugh grade C), severe renal dysfunction (preoperative dialysis), or American Society of Anesthesiologists grade ≥ IV;
• Barrier in communication;
• Other conditions that are considered unsuitable for study participation.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (20)

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  PMID: 37302963 DERIVED

MeSH Terms

Interventions

Esketamine; Dexmedetomidine; Sufentanil

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl; Piperidines

Study Officials

• Dong-Xin Wang, MD,PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 10, 2021
• Study Start: April 9, 2021
• Primary Completion: September 7, 2022
• Study Completion: October 7, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)