CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 36 target
Drug / intervention
Bupivacaine +5 moredrug
Likely dose
Bupivacaine 10 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/NCT00991627
NCT00991627Phase 4Completed

Pharmacological or Non-Pharmacological Management of Maternal Hypotension During Elective Cesarean Section Under Subarachnoid Anesthesia: a Randomized, Controlled Trial

University of Parma·interventional·Posted Oct 8, 2009·Updated Aug 27, 2010

In Brief

A Phase 4 clinical trial evaluating Bupivacaine, Morphine, and 4 other interventions for Pregnancy and 3 related conditions. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The aim of this study is to compare two different therapeutic approaches to blood pressure reduction: pharmacological vs. non-pharmacological. The setting is that of patients undergoing scheduled Cesarean section under spinal anesthesia and suffering from aorta-caval compression syndrome, which causes a sudden drop in blood pressure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2009
Enrollment StartSep 1, 2009
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.7 years ago

Interventions

Bupivacainedrug

10 mg of a 5 mg/ml hyperbaric solution, intrathecally

Morphinedrug

200 µg of a 100 µg/ml solution, intrathecally

Lactated Ringer's solutiondrug

25 ml/min intravenously

Ephedrine, continuous infusiondrug

37.5 mg/h intravenously

Ephedrine, bolusdrug

6.25 mg IV bolus prn. Hypotension defined according to study protocol for each arm.

Atropinedrug

0.1 mg/kg iv bolus prn Bradycardia defined as 50% drop in heart rate from baseline values.