Dexmedetomidine Infusion in Hypospadias Surgery

NCT ID: NCT00926705

Last Updated: 2009-06-23

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Fentanyl

This group received Fentanyl at a dose of 2 ug/kg initially, followed by boluses to keep the patient hemodynamically stable.

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

This group received Fentanyl at a dose of 2 ug/kg initially, followed by boluses to keep the patient hemodynamically stable.

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.

Group Type EXPERIMENTAL

Dexmedetomidine and Fentanyl

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Fentanyl

This group received Fentanyl at a dose of 2 ug/kg initially, followed by boluses to keep the patient hemodynamically stable.

Intervention Type DRUG

Other Intervention Names

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Precedex

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Jordan

OTHER

Sponsor Role lead

Responsible Party

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University of Jordan

Principal Investigators

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Khaled R Al-Zaben, MD

Role: STUDY_CHAIR

University of Jordan

Locations

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Jordan University Hospital

Amman, , Jordan

Site Status

Countries

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Jordan

References

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Virtanen R, Savola JM, Saano V, Nyman L. Characterization of the selectivity, specificity and potency of medetomidine as an alpha 2-adrenoceptor agonist. Eur J Pharmacol. 1988 May 20;150(1-2):9-14. doi: 10.1016/0014-2999(88)90744-3.

Reference Type RESULT
PMID: 2900154 (View on PubMed)

Gurbet A, Basagan-Mogol E, Turker G, Ugun F, Kaya FN, Ozcan B. Intraoperative infusion of dexmedetomidine reduces perioperative analgesic requirements. Can J Anaesth. 2006 Jul;53(7):646-52. doi: 10.1007/BF03021622.

Reference Type RESULT
PMID: 16803911 (View on PubMed)

Arain SR, Ruehlow RM, Uhrich TD, Ebert TJ. The efficacy of dexmedetomidine versus morphine for postoperative analgesia after major inpatient surgery. Anesth Analg. 2004 Jan;98(1):153-158. doi: 10.1213/01.ANE.0000093225.39866.75.

Reference Type RESULT
PMID: 14693611 (View on PubMed)

Tobias JD, Berkenbosch JW. Sedation during mechanical ventilation in infants and children: dexmedetomidine versus midazolam. South Med J. 2004 May;97(5):451-5. doi: 10.1097/00007611-200405000-00007.

Reference Type RESULT
PMID: 15180019 (View on PubMed)

Ibacache ME, Munoz HR, Brandes V, Morales AL. Single-dose dexmedetomidine reduces agitation after sevoflurane anesthesia in children. Anesth Analg. 2004 Jan;98(1):60-63. doi: 10.1213/01.ANE.0000094947.20838.8E.

Reference Type RESULT
PMID: 14693585 (View on PubMed)

Other Identifiers

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alghanem2

Identifier Type: -

Identifier Source: org_study_id

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