Intravenous Dexmedetomidine in Cesarean Section Under Spinal Anesthesia

Cesarean Section Complications Clinical Trial

Official title: Intravenous Dexmedetomidine Reduces Hypotension and Epigastric Pain in Cesarean Section Under Spinal Anesthesia: A Randomized Clinical Study

Status Completed

Clinical Trial Summary

The present study hypothesized that intravenous dexmedetomidine use during spinal anesthesia for cesarean section has a beneficial influence on hemodynamic stability and epigastric pain together with satisfactory analgesic effects and excellent safety profile for the mother and the newborn.

Clinical Trial Description

Background and aim: Hypotension and epigastric pain are commonly encountered during spinal anesthesia for cesarean section. Dexmedetomidine (DEX) is a highly selective α 2-adrenergic agonist. Its effects entail sympatholytic, sedative, anesthetic, and analgesic actions. The present randomized study aimed to evaluate the effect of intravenous DEX administration on the hemodynamic parameters and epigastric pain in women subjected to cesarean section.

Patients and Methods: This study is a randomized double-blinded controlled trial. Seventy patients were randomly assigned to one of two interventional groups: one group received spinal anesthesia and intravenous DEX (1µg/kg) and the other group received spinal anesthesia and placebo (saline). The administrated drugs were slowly injected intravenously over 10 minutes then intrathecal block was achieved using 2-2.2 ml of hyperbaric bupivacaine (10 -12.5 mg) introduced at L3/4 or L4/5 interspace. Primary Outcome parameters included frequency of hypotension episodes, frequency of ephedrine doses needed, sedation score and epigastric pain episodes. Secondary outcomes included time to onset of sensory and motor blocks, duration of sensory and motor blocks, operative duration, time needed to request of rescue analgesia, level of intrathecal block, and neonatal Apgar score at 1 and 5 minutes. ;

Related Conditions & MeSH terms

• Cesarean Section Complications

• NCT number: NCT04358367
• Study type: Interventional
• Source: Egyptian Biomedical Research Network
• Status: Completed
• Phase: Phase 3
• Start date: May 19, 2019
• Completion date: November 19, 2019