Dexmedetomidine Infusion in Hypospadias Surgery

This study has been completed.
Information provided by:
University of Jordan Identifier:
First received: June 22, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
The investigators hypothesize that giving Dexmedetomidine in combination with Fentanyl for pediatric patients undergoing hypospadias surgery, will reduce the fentanyl requirement for intraoperative and postoperative analgesia.

Condition Intervention Phase
Drug: Dexmedetomidine and Fentanyl
Drug: Fentanyl
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: An Intraoperative Infusion of Dexmedetomidine Reduces the Opioid Requirements for Pediatric Patients Undergoing Hypospadias Surgery

Resource links provided by NLM:

Further study details as provided by University of Jordan:

Primary Outcome Measures:
  • Intraoperative and postoperative fentanyl requirement (in microg/kg) [ Time Frame: 6/2008-1/2009 ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: June 2008
Study Completion Date: January 2009
Arms Assigned Interventions
Active Comparator: Fentanyl
This group received Fentanyl at a dose of 2 ug/kg initially, followed by boluses to keep the patient hemodynamically stable.
Drug: Fentanyl
This group received Fentanyl at a dose of 2 ug/kg initially, followed by boluses to keep the patient hemodynamically stable.
Experimental: Dexmedetomidine and Fentanyl
This group received a combination of Dexmedetomidine (1 ug/kg) and Fentanyl (1.79 ug/kg). Total number of patients in this group 24.
Drug: Dexmedetomidine and Fentanyl
Dexmedetomidine in a dose of 1 ug/kg initial dose then continuous infusion of 0.7 ug/kg/hr . Combined with Fentanyl at a dose of 2 ug/kg initially plus boluses of fentanyl to keep the patient hemodynamically stable.
Other Name: Precedex


Ages Eligible for Study:   1 Year to 12 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children aged 1-12 years undergoing hypospadias repair

Exclusion Criteria:

  • Allergy to Dexmedetomidine
  • Preoperative use of sedatives or analgesics
  • cardiac diseases
  • Children with mental retardation
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Please refer to this study by its identifier: NCT00926705

Jordan University Hospital
Amman, Jordan, 11942
Sponsors and Collaborators
University of Jordan
Study Chair: Khaled R Al-Zaben, MD University of Jordan
  More Information

Responsible Party: University of Jordan Identifier: NCT00926705     History of Changes
Other Study ID Numbers: alghanem2 
Study First Received: June 22, 2009
Last Updated: June 22, 2009
Health Authority: Jordan: Ethical Committee

Keywords provided by University of Jordan:

Additional relevant MeSH terms:
Congenital Abnormalities
Genital Diseases, Male
Penile Diseases
Urogenital Abnormalities
Adjuvants, Anesthesia
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics, Non-Narcotic
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 26, 2016