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NCT04791059
Low-dose S-ketamine and Dexmedetomidine in Combination With Opioids for Postoperative Analgesia
Phase 4 trial testing S-ketamine in Scoliosis Correction in 200 participants. Completed in 7 October 2022.
7 September 2022
Quick facts
| Lead sponsor | Peking University First Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 9 April 2021 |
| Primary completion | 7 September 2022 |
| Estimated completion | 7 October 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- S-ketamine
- Dexmedetomidine (dexmedetomidine) — full drug profile →
- Sufentanil (SUFENTANIL) — full drug profile →
Conditions studied
- Scoliosis Correction — all drugs for Scoliosis Correction →
- Postoperative Analgesia — all drugs for Postoperative Analgesia →
- S-ketamine — all drugs for S-ketamine →
- Dexmedetomidine — all drugs for Dexmedetomidine →
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):
-
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:
- PubMed search for NCT04791059
- Europe PMC full search
- ASCO Meeting Library
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Related trials
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Trials testing the same drug.
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- NCT05414006 — Effect of S-ketamine in Cesarean Section Combined Anesthesia · Phase 4 · completed
- NCT05289050 — Analgesic Effect of Intraoperative Intravenous S-Ketamine During Total Knee Arthroplasty Surgery · Phase 4 · unknown
- NCT05299866 — The Effect of S-ketamine Combined With Sufentanil for Postoperative Analgesia in Patients Following Cesarean Section · Phase 4 · unknown
- NCT05242692 — The Effects of Subanesthetic S-ketamine on Postoperative Delirium and Cognitive Function in the Elderly Undergoing Non-c · EARLY_PHASE1 · completed
Other recruiting trials for Scoliosis Correction
Currently open trials in the same condition.
- NCT07217873 — IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study · Phase 2, PHASE3 · recruiting
Other Peking University First Hospital trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04791059 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking University First Hospital
- Last refreshed: 13 December 2022
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