CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Phenylephrine Hydrochloride 4 mg +1 moredrug
Likely dose
Phenylephrine Hydrochloride 4 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/NCT05348980
NCT05348980Phase 4Completed

Comparison of Two Different Doses of Intramuscular Phenylephrine HCL for Prevention of Spinal Anesthesia Induced Hypotension During Cesarean Section: A Prospective Randomized Double-blinded Parallel Study

Rehman Medical Institute - RMI·interventional·Posted Apr 27, 2022·Updated Apr 27, 2022

In Brief

A Phase 4 clinical trial evaluating Phenylephrine Hydrochloride 4 mg and Phenylephrine Hydrochloride 8 mg for Hypotension and Anesthesia. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Background: Spinal anesthesia (SA) is preferred over general anesthesia in Cesarean section (CS) due to its better safety profile but SA induced hypotension remains a big challenge for the clinical Anesthetist. Different methods including 15° left lateral table tilt, leftward uterine manual displacement, fluid pre-and co-loading have been used but drop in Systolic Blood Pressure (SBP) jeopardizing maternal and fetal well-being still occurs. Timely administered Phenylephrine HCL, an α-1 adrenergic agonist, is a recommended remedy. Subjects and methods: Sixty parturients of American Society of Anaesthesiologists (ASA) physical status 1 and 2, scheduled for elective CS under SA were enrolled in this prospective double-blinded study and randomly divided into two equal groups, P4 and P8. They received intramuscular (IM) Phenylephrine HCL 04 mg and 08 mg respectively before SA. Spinal block up to T6 was achieved with 12.5 mg 0.5% Bupivacaine HCl heavy. The incidence and intensity of hypotension, rescue doses of Phenylephrine HCL and any adverse event, were recorded. Data collected was analyzed using Epi lnfo ™ version 7.2.

Study Details

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

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedApr 27, 2022
Enrollment StartJan 1, 2020
Primary CompletionJul 31, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.2 years ago

Interventions

Phenylephrine Hydrochloride 4 mgdrug

Intramuscular Phenylephrine HCL 04 mg were administered as prophylactic stat dose in Vastus lateralis muscle of thigh 05 minutes before giving spinal anesthesia.

Phenylephrine Hydrochloride 8 mgdrug

Intramuscular Phenylephrine HCL 08 mg were administered as prophylactic stat dose in Vastus lateralis muscle of thigh 05 minutes before giving spinal anesthesia.