Intravenous Dexmedetomidine in Cesarean Section Under Spinal Anesthesia

NCT04358367 | Completed Phase 3

• 1 other identifier: 01041620
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section Complications

Keywords

dexmedetomidine; spinal anesthesia; cesarean section; epigastric pain

Outcome Measures

Primary Outcomes (4)

• hypotension

  systolic blood pressure \< 90 mmHg

  up to 48 hours postoperative

• ephedrine use

  frequency of ephedrine doses needed

  up to 48 hours postoperative

• sedation

  sedation score

  up to 48 hours postoperative

• epigastric pain

  Pain in the epigastric region assessed by Visual Analog Scale

  up to 48 hours postoperative

Secondary Outcomes (1)

• sensory and motor blocks

  Intraoperative

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

spinal anesthesia and intravenous dexmedetomidine(1µg/kg)

Drug: Dexmedetomidine Injectable Product

Saline

PLACEBO COMPARATOR

spinal anesthesia and placebo (saline).

Drug: Saline

Interventions

Dexmedetomidine Injectable Product DRUG

Spinal anesthesia and intravenous dexmedetomidine (1μg/kg). 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.

Also known as: Precedex

Dexmedetomidine

Saline DRUG

Spinal anesthesia and intravenous 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.

Also known as: saline solution

Saline

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Egyptian Biomedical Research Network: lead

Study Sites (1)

Al-Azhar University Faculty of Medicine

Cairo, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Sodium Chloride; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ahmed Elsawy, MD

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 24, 2020
• Study Start: May 19, 2019
• Primary Completion: October 19, 2019
• Study Completion: November 19, 2019
• Last Updated: July 23, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)