Intravenous Dexmedetomidine in Cesarean Section Under Spinal Anesthesia

Phase 3

Completed

• Conditions: Cesarean Section Complications
• Interventions: Drug: Dexmedetomidine Injectable Product; Drug: Saline

• Registration Number: NCT04358367
• Lead Sponsor: Egyptian Biomedical Research Network

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-05-19
• Primary Completion: 2019-10-19
• Study Completion: 2019-11-19
• Status Verified: 2020-04
• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-20
• Study First Posted: 2020-04-24
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Full-term pregnancy and American Society of Anesthesiologists (ASA) physical status I/II in women scheduled for elective cesarean section

Exclusion Criteria

• Severe hepatic or renal disease
• Severe cardiopulmonary disease
• Thyroid disorders multiple allergies prematurity
• Known fatal abnormality
• Known chronic gastrointestinal problems with epigastric pain e.g. peptic ulcer and reflux esophagitis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine Injectable Product	spinal anesthesia and intravenous dexmedetomidine(1µg/kg)
Saline	Saline	spinal anesthesia and placebo (saline).

Primary Outcome Measures

Name	Time	Method
epigastric pain	up to 48 hours postoperative	Pain in the epigastric region assessed by Visual Analog Scale
ephedrine use	up to 48 hours postoperative	frequency of ephedrine doses needed
sedation	up to 48 hours postoperative	sedation score
hypotension	up to 48 hours postoperative	systolic blood pressure \< 90 mmHg

Secondary Outcome Measures

Name	Time	Method
sensory and motor blocks	Intraoperative	time to onset of sensory and motor blocks

Trial Locations

Locations (1)

Al-Azhar University Faculty of Medicine; 🇪🇬 Cairo, Egypt