CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 200 enrolled
Drug / intervention
Dexmedetomidine +1 moredrug
Likely dose
Dexmedetomidine 0.45 microgramfrom 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/NCT05698407
NCT05698407Phase 4Completed

Effect of Dexmedetomidine Plus Ropivacaine Versus Sufentanil Plus Ropivacaine for Epidural Labor Analgesia on Neonatal Outcomes: a Pilot Randomized Trial

Peking University First Hospital·interventional·Posted Jan 26, 2023·Updated Jan 3, 2024

In Brief

A Phase 4 clinical trial evaluating Dexmedetomidine and Sufentanil for Pregnancy Related. Completed, enrolled 200 participants across 1 site.

Detailed Summary

Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events. Dexmedetomidine is a high selective alpha2-adrenoceptor agonist. Mounting evidences show that dexmedetomidine-ropivacaine combination can also be used effectively for epidural labor analgesia. This pilot trial is designed to compare the effect of dexmedetomidine-ropivacaine combination versus sufentanil-ropivacaine combination on neonatal outcomes when used for epidural labor analgesia, and to test the feasibility of a future large randomized trial.

Study Details

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

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedJan 26, 2023
Enrollment StartMar 16, 2023
Primary CompletionJun 15, 2023
Study CompletionAug 28, 2023
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 3.4 years ago

Interventions

Dexmedetomidinedrug

loading dose of 0.45 microgram/ml dexmedetomidine plus 0.09% ropivacaine, maintenance dose of 0.36 microgram/ml dexmedetomidine plus 0.07% ropivacaine.

Sufentanildrug

loading dose of 0.45 microgram/ml sufentanil plus 0.09% ropivacaine, maintenance dose of 0.36 microgram/ml sufentanil plus 0.07% ropivacaine.