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

September 25, 2017 updated by: jehan ahmed sayed, Assiut University

Pediatric Caudal Epidural Dexmedetomidine Enhances Postoperative Analgesia of Magnesium Sulphate and Quality of Caudal Anesthesia in Lower Abdominal Surgeries

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

asdsd

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 715715
        • Recruiting
        • Assiut Univeristy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group (MG)
Magnesium sulfate 50 mg add to 1 ml/kg of 0.25%of bupivacaine
Drug: Magnesium Sulphate
Magnesium Sulphate 50 mg
Active Comparator: group (D)
Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine
Drug: Dexmedetomidine
Dexmedetomidine 1 μg/ kg
Active Comparator: group (MD)
50 mg magnesium sulfate and Dexmedetomidine 1 μg/ kg to add to 1ml/kg of 0.25%of bupivacaine
Drug: Dexmedetomidine + Magnesium Sulphate + Bupivacaine
Dexmedetomidine 1 μg/ kg + Magnesium Sulphate 50 mg + 1ml/kg of 0.25%of bupivacaine
Active Comparator: group (C)
1ml/kg of 0.25%of bupivacaine + 1 ml of normal saline
Drug: Bupivacaine
1ml/kg of 0.25%of bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first analgesic requirement
Time Frame: 24 hours
The time from end of surgery to the first requirement of postoperative analgesia
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative sedation scores
Time Frame: 24 hours
Level of sedation was recorded throughout the post-anesthesia care unit stay at 15-minute time intervals
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: jehan A Sayed, MD, assistant professor in anesthesia and intensive care department,faculty of medicine,Assiut univeristy,egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

June 29, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Actual)

September 26, 2017

Last Update Submitted That Met QC Criteria

September 25, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB000087123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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