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Pediatric Caudal Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate in Lower Abdominal Surgeries

NCT ID: NCT02487355

Last Updated: 2017-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-12-31

Brief Summary

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The study will conduct to compare the efficacy of Magnesium sulphate \& dexmedetomidine used as adjuvants to bupivacaine in caudal block to provide intra-operative anesthesia as well as post -operative analgesia in pediatric patients.

Detailed Description

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asdsd

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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group (MG)

Magnesium sulfate 50 mg add to 1 ml/kg of 0.25%of bupivacaine

Group Type ACTIVE_COMPARATOR

Magnesium Sulphate

Intervention Type DRUG

Magnesium Sulphate 50 mg

group (D)

Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine 1 μg/ kg

group (MD)

50 mg magnesium sulfate and Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine

Group Type ACTIVE_COMPARATOR

Dexmedetomidine + Magnesium Sulphate + Bupivacaine

Intervention Type DRUG

Dexmedetomidine 1 μg/ kg + Magnesium Sulphate 50 mg + 1ml/kg of 0.25%of bupivacaine

group (C)

1ml/kg of 0.25%of bupivacaine + 1 ml of normal saline

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

1ml/kg of 0.25%of bupivacaine

Interventions

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Dexmedetomidine

Dexmedetomidine 1 μg/ kg

Intervention Type DRUG

Magnesium Sulphate

Magnesium Sulphate 50 mg

Intervention Type DRUG

Bupivacaine

1ml/kg of 0.25%of bupivacaine

Intervention Type DRUG

Dexmedetomidine + Magnesium Sulphate + Bupivacaine

Dexmedetomidine 1 μg/ kg + Magnesium Sulphate 50 mg + 1ml/kg of 0.25%of bupivacaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female children, ASA I and II,Aged 6 months to 6 years, , undergoing elective surgical procedures expected to last more than 90 min, and scheduled to receive general anesthesia combined with caudal extradural block

Exclusion Criteria

* Allergy to local anesthetics,coagulation disorders, infection at site of injection, anatomic abnormalities and congenital anomalies like spina bifid, ASA III or higher, Parental refusal and the current use of Calcium Channel Blockers or Medication that may affect the neurologic system
Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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jehan ahmed sayed

Associate Professor (Anesthesiology and Critical Care)- College of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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jehan A Sayed, MD

Role: PRINCIPAL_INVESTIGATOR

assistant professor in anesthesia and intensive care department,faculty of medicine,Assiut univeristy,egypt

Locations

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Assiut Univeristy Hospital

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Jehan A Sayed, MD

Role: CONTACT

[email protected]
+2 01006253939

mohamed amir, MD

Role: CONTACT

[email protected]
+01005689353

Facility Contacts

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jehan A sayed, MD

Role: primary

[email protected]
+2 01006253939

Other Identifiers

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IRB000087123

Identifier Type: -

Identifier Source: org_study_id