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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04358367
• Other study ID #: 01041620
• Status: Completed
• Phase: Phase 3
• Start date: May 19, 2019
• Est. completion date: November 19, 2019

Study information

• Verified date: April 2020
• Source: Egyptian Biomedical Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 19, 2019
• Est. primary completion date: October 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

Drug:
• Dexmedetomidine Injectable Product
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.
• Saline
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.

Locations

Country	Name	City	State
Egypt	Al-Azhar University Faculty of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Egyptian Biomedical Research Network

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hypotension	systolic blood pressure < 90 mmHg	up to 48 hours postoperative
Primary	ephedrine use	frequency of ephedrine doses needed	up to 48 hours postoperative
Primary	sedation	sedation score	up to 48 hours postoperative
Primary	epigastric pain	Pain in the epigastric region assessed by Visual Analog Scale	up to 48 hours postoperative
Secondary	sensory and motor blocks	time to onset of sensory and motor blocks	Intraoperative