CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 200 enrolled
Drug / intervention
S-ketamine +2 moredrug
Likely dose
S-ketamine 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04791059
NCT04791059Phase 4Completed

Low-dose S-ketamine and Dexmedetomidine in Combination With Opioids for Patient-controlled Analgesia After Scoliosis Correction Surgery: a Randomized, Double-blind, Placebo-controlled Trial

Peking University First Hospital·interventional·Posted Mar 10, 2021·Updated Dec 13, 2022

In Brief

A Phase 4 clinical trial evaluating S-ketamine, Dexmedetomidine, and 1 other intervention for Scoliosis Correction and 4 related conditions. Completed, enrolled 200 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedMar 10, 2021
Enrollment StartApr 9, 2021
Primary CompletionSep 7, 2022
Study CompletionOct 7, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.3 years ago

Interventions

S-ketaminedrug

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

Dexmedetomidinedrug

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

Sufentanildrug

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