DEXMEDETOMIDINE in NORMAL VAGINAL DELIVERY

NCT05840328 | Unknown Phase 4

• 1 other identifier: 11/2022ANET49
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Painless Vainal Labour

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

plan group

PLACEBO COMPARATOR

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

epidural group

ACTIVE COMPARATOR

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: Dexmedetomidine Injection [Precedex]; Drug: Bupivacaine Injection

intravenous group

ACTIVE COMPARATOR

continuous intravenous dexmetomidine infusion at rate of 0.5 µg / kg / hour in addition to same epidural infusion of 0.125% bupivacaine

Drug: Dexmedetomidine Injection [Precedex]; Drug: Bupivacaine Injection

Interventions

Dexmedetomidine Injection [Precedex] DRUG

interventional drug will be administred either intravenously or epidurally

epidural group; intravenous group

Bupivacaine Injection DRUG

intervention drug will be administred epidurally

epidural group; intravenous group; plan group

Eligibility Criteria

• Age: 19 Years - 30 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University Hospitals

Shibīn al Kawm, Menoufia, 32513, Egypt

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Bupivacaine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• mostafa M mansour, MD

  Menoufia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mostafa S mansour, MD

CONTACT

01225484055; mostafa.said@med.menofia.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 3, 2023
• Study Start: December 5, 2022
• Primary Completion: June 5, 2023
• Study Completion: July 5, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)