CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 42 enrolled
Drug / intervention
Dexmedetomidine 0.004 MG/ML [Precedex] +1 moredrug
Likely dose
Dexmedetomidine 0.004 MG/ML [Precedex]from 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/NCT05099055
NCT05099055Phase 3Completed
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Dexmedetomidine Comme Adjuvant à la rachianesthésie Lors de césariennes électives : Une étude Pilote

St. Justine's Hospital·interventional·Posted Oct 29, 2021·Updated May 9, 2023

In Brief

A Phase 3 clinical trial evaluating Dexmedetomidine 0.004 MG/ML [Precedex] and Opioids for Analgesia and 6 related conditions. Completed, enrolled 42 participants across 1 site.

Detailed Summary

The proposed pilot study is a prospective, randomized, controlled, double-blind, single-center pilot study.The aim of this pilot project is to evaluate the feasibility of a phase III study on the use of dexmedetomidine in intrathecal in the context of elective cesarean section. The target population for the study will be adult pregnant women undergoing elective cesarean section under spinal anesthesia. This study will be carried out at a single site, the CHU Sainte-Justine as part of a research internship as part of the anesthesiology residency program at the University of Montreal.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnalgesia, Analgesics, Opioid, Anesthesia, Obstetrical, Anesthesia, Spinal, Analgesics, Non-Narcotic, Dexmedetomidine, Analgesia, Obstetrical
CountriesCanada
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedOct 29, 2021
Enrollment StartMar 15, 2022
Primary CompletionJan 20, 2023
Study CompletionMay 5, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 4.7 years ago

Interventions

Dexmedetomidine 0.004 MG/ML [Precedex]drug

Injection of 3 mcg of dexmedetomidine and 12 mg of bupivacaine in the intrathecal space to provide spinal anesthesia.

Opioidsdrug

Injection of 100 mcg of morphine, 15 mcg of fentanyl and 0.25 ml of normal salin (sterile) with 12 mg of bupivacaine in the intrathecal space to provide spinal anesthesia.