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Completed

NCT Number: NCT04358367

Intravenous Dexmedetomidine in Cesarean Section Under Spinal Anesthesia

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Al-Azhar University Faculty of Medicine

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Precedex

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.

Other names: saline solution

Primary outcomes

  1. hypotension

    Time frame: up to 48 hours postoperative

    systolic blood pressure < 90 mmHg

  2. ephedrine use

    Time frame: up to 48 hours postoperative

    frequency of ephedrine doses needed

  3. sedation

    Time frame: up to 48 hours postoperative

    sedation score

  4. epigastric pain

    Time frame: up to 48 hours postoperative

    Pain in the epigastric region assessed by Visual Analog Scale

Secondary outcomes

  1. sensory and motor blocks

    Time frame: Intraoperative

    time to onset of sensory and motor blocks

Sponsors and collaborators

Lead sponsor

Egyptian Biomedical Research Network

Network

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2020
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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