DEXMEDETOMIDINE in NORMAL VAGINAL DELIVERY

INTRAVENOUS Versus EPIDURAL DEXMEDETOMIDINE for ANALGESIA in NORMAL VAGINAL DELIVERY: A RANDOMIZED CONTROLED STUDY

compare the effect of intravenous and epidural dexmetomidine as an adjuvant to local anesthetics in epidural labor analgesia in normal labor

Study Overview

• Status: Recruiting
• Conditions: Painless Vainal Labour
• Intervention / Treatment: Drug: Bupivacaine Injection; Drug: Dexmedetomidine Injection [Precedex]

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: mostafa S mansour, MD; Phone Number: 01225484055; Email: mostafa.said@med.menofia.edu.eg

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt, 32513
      • Recruiting
      • Menoufia University Hospitals
      • Contact: Ghada Ali; Phone Number: 01001775783; Email: ghadaali132@yahoo.com
      • Principal Investigator: ashraf m eskandr
      • Principal Investigator: ghada ali
      • Principal Investigator: nehal elsafty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Full term (≥ 37 weeks) healthy primigravida parturients ASA2
• with single fetus scheduled for vaginal delivery
• with cephalic presentation
• requesting labor analgesia.

Exclusion Criteria:

• Allergy to dexmetomidine.(based on previous history)
• Cardiac conduction abnormalities.(all degrees of heart block , tachyarrythmias)
• Twins.
• Malpresentation.
• Preeclampsia or gestational hypertension
• Uncontrolled diabetes HBA1c ≥ 6.5%
• Uncontrolled renal failure
• Uncontrolled liver disease
• Bleeding tendency or coagulopathy.
• Contraindication or patient refusal to epidural block.
• Body mass index ≥ 35.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: plan group; bupivacaine will be administered epidurally as a loading dose then epidural continuous infusion with 0.125 % bupivacaine at rate 10 ml will be a maintainance for analgesia .IV placebo (normal saline) infusion will be connected to each patient at a rate of 10 ml \hr.	Drug: Bupivacaine Injection; intervention drug will be administred epidurally
Active Comparator: epidural group; 10 ml of 0.125 % buoivacaine with 0.5 µg\ml dexmetomidine as a loading dose then continuous epidural infusion of 0.125% bupivacaine with 0.5µ/ml dexmetomidine at a rate of 10 ml\hr will be used as maintainance . IV placebo (normal saline) infusion will be connected to each patient at a rate of 10 ml\hr	Drug: Bupivacaine Injection; intervention drug will be administred epidurally; Drug: Dexmedetomidine Injection [Precedex]; interventional drug will be administred either intravenously or epidurally
Active Comparator: intravenous group; continuous intravenous dexmetomidine infusion at rate of 0.5 µg / kg / hour in addition to same epidural infusion of 0.125% bupivacaine	Drug: Bupivacaine Injection; intervention drug will be administred epidurally; Drug: Dexmedetomidine Injection [Precedex]; interventional drug will be administred either intravenously or epidurally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain relief	VAS score from 0 to 10 will be assesed	at 30 min after induction of block
pain relief	VAS score from 0 to 10	on delivery

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Principal Investigator: mostafa M mansour, MD, Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Anticipated): June 5, 2023
• Study Completion (Anticipated): July 5, 2023

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: 11/2022ANET49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No