CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 124 enrolled
Drug / intervention
Norepinephrine +1 moredrug
Likely dose
Norepinephrine 0,1μgfrom 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/NCT03849508
NCT03849508Phase 4Completed

Randomized, Double-blind, Controlled Clinical Trial for Comparison of Continuous Phenylephrine Versus Norepinephrine Infusion for Maintenance of Hemodynamic Stability During Cesarean Section Under Spinal Anesthesia

Centre Hospitalier Régional d'Orléans·interventional·Posted Feb 21, 2019·Updated May 27, 2021

In Brief

A Phase 4 clinical trial evaluating Norepinephrine and Phenylephrine for Cesarean Section Complications and Spinal Anesthesia. Completed, enrolled 124 participants across 1 site.

Detailed Summary

Comparison between prophylactic continuous variable infusion of phenylephrine (starting dose 0,5mcg/kg/min) and norepinephrine tartrate (starting dose 0,1mcg/kg/min) to prevent hypotension and maintain cardiac output under spinal anesthesia during cesarean delivery.

Study Details

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

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedFeb 21, 2019
Enrollment StartFeb 27, 2019
Primary CompletionDec 2, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.4 years ago

Interventions

Norepinephrinedrug

Drug: Norepinephrine Norepinephrine tartrate variable infusion with a starting rate of 0,1μg/kg/min (equivalent to norepinephrine base of 0.05 μg /Kg/min). Other name: Noradrenaline Drug: Hyperbaric Bupivacaine will be injected in the subarachnoid space with a dose of 8 to 12 mg adjusted according to height Drug: Sufentanil will be injected in the subarachnoid space with a dose of 2,5μg Drug: Morphine will be injected in the subarachnoid space with a dose of 100 μg

Phenylephrinedrug

Drug: Phenylephrine variable infusion with a starting rate of 0,5μg/kg/min Drug: Hyperbaric Bupivacaine will be injected in the subarachnoid space with a dose of 8 to 12 mg adjusted according to height Drug: Sufentanil will be injected in the subarachnoid space with a dose of 2,5μg Drug: Morphine will be injected in the subarachnoid space with a dose of 100 μg