CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 99 enrolled
Drug / intervention
Phenylephrine +2 moredrug
Likely dose
Phenylephrine 5 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/NCT03507387
NCT03507387N/ACompleted

Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia: A Randomized Controlled Tiral

Xuzhou Medical University·interventional·Posted Apr 25, 2018·Updated Jul 5, 2019

In Brief

A clinical study evaluating Phenylephrine, Normal saline, and 1 other intervention for Elective Cesarean Section and Spinal Anesthesia. Completed, enrolled 99 participants across 1 site.

Detailed Summary

Spinal anesthesia is the preferred anesthesia method in cesarean section to provide satisfactory analgesia and muscle relaxant with less impact on respiratory system. However, hypotension often occurred due to the block of sympathetic nerve, causing maternal decline of frontal lobe oxygenation, nausea vomit and the decrease of uteroplacental perfusion. Several measures are used to prevent or treat hypotension caused by spinal anesthesia: prehydration, limb compression, left lateral tilt of operation tables or usage of vasopressors. In the past decade, the most recommended vasopressor to prevent or treat hypotension in spinal anesthesia in cesarean section was phenylephrine, an α-adrenergic receptor, maintaining maternal blood pressure and fetal acid-base state. In clinical work, there are two ways to use phenylephrine : intravenous method with less onset time (several seconds and duration (several minutes) and intramuscular method with longer onset time (10-15 minutes) and duration (1 hour). Many trials demonstrated the protective effect of preventive intravenous phenylephrine on maternal hemodynamics and neonatal acid-base status. However, few trials reported the effect of preventive intramuscular phenylephrine on cesarean section under spinal anesthesia.

Study Details

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

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 25, 2018
Enrollment StartApr 1, 2018
Primary CompletionAug 31, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.2 years ago

Interventions

Phenylephrinedrug

5 mg (1ml) phenylephrine intramuscular injection will be given into the gluteus maximus muscle before anesthesia.100ug (1ml) phenylephrine intravenous injection will be given after the subarachnoid injection is completed .

Normal salinedrug

1ml 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia and after the subarachnoid injection is completed.

Bupivacainedrug

All patients will receive spinal anesthesia with bupivacaine.