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NCT04791059

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

Completed Phase 4 Last updated 13 December 2022
What this trial tests

Phase 4 trial testing S-ketamine in Scoliosis Correction in 200 participants. Completed in 7 October 2022.

Timeline
9 April 2021
Primary endpoint
7 September 2022
7 October 2022

Quick facts

Lead sponsorPeking University First Hospital
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment200
Start date9 April 2021
Primary completion7 September 2022
Estimated completion7 October 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Peking University First Hospital

Who can join

18 and older, any sex, with Scoliosis Correction or Postoperative Analgesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Mini-dose esketamine-dexmedetomidine combination to supplement analgesia for patients after scoliosis correction surgery: a double-blind randomised trial.
    Zhang Y, Cui F, Ma JH, Wang DX. · · 2023 · cited 47× · PMID 37302963 · DOI 10.1016/j.bja.2023.05.001

Verify or expand the search:

Other trials of S-ketamine

Trials testing the same drug.

Other recruiting trials for Scoliosis Correction

Currently open trials in the same condition.

Other Peking University First Hospital trials

Trials by the same sponsor.

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