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

NCT04791059 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-12-13

No results posted yet for this study

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

Interventions

DRUG

S-ketamine

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

DRUG

Dexmedetomidine

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

DRUG

Sufentanil

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

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Dong-Xin Wang, MD,PhD · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-09
Primary Completion
2022-09-07
Completion
2022-10-07

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04791059 on ClinicalTrials.gov