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Dexmedetomidine Infusion in Hypospadias Surgery

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ClinicalTrials.gov Identifier: NCT00926705
Recruitment Status : Completed
First Posted : June 23, 2009
Last Update Posted : June 23, 2009
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Pain Drug: Dexmedetomidine and Fentanyl Drug: Fentanyl Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: An Intraoperative Infusion of Dexmedetomidine Reduces the Opioid Requirements for Pediatric Patients Undergoing Hypospadias Surgery
Study Start Date : June 2008
Study Completion Date : January 2009

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Intraoperative and postoperative fentanyl requirement (in microg/kg) [ Time Frame: 6/2008-1/2009 ]

Eligibility Criteria

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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes 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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00926705     History of Changes
Other Study ID Numbers: alghanem2
First Posted: June 23, 2009    Key Record Dates
Last Update Posted: June 23, 2009
Last Verified: June 2009

Keywords provided by University of Jordan:

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