Dexmedetomidine, Ketamine and Magnesium Sulphate in Caudal Block for Hypospadias Repair

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

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-15

Study Completion Date

2024-10-25

Brief Summary

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Caudal epidural block is a rapid, reliable, and safe technique that can be used with general anesthesia for intraoperative and postoperative analgesia in pediatric patients Ketamine is a selective antagonist of N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor.

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Detailed Description

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Conditions

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Preemptive Analgesia Dexmedetomidine Ketamine Magnesium Sulphate Hypospadias Pediatrics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dexmedetomidine

0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Patient will receive 0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally

Ketamine

0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Patient will receive 0.5ml/kg bupivacaine 0.25% + 0.5mg/kg ketamine caudally

Magnesium sulphate

0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally.

Group Type EXPERIMENTAL

Magnesium sulphate

Intervention Type DRUG

Patient will receive 0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally.

Interventions

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Dexmedetomidine

Patient will receive 0.5 ml/kg bupivacaine 0.25% + 1μg/kg dexmedetomidine caudally

Intervention Type DRUG

Ketamine

Patient will receive 0.5ml/kg bupivacaine 0.25% + 0.5mg/kg ketamine caudally

Intervention Type DRUG

Magnesium sulphate

Patient will receive 0.5ml/kg bupivacaine 0.25% + 1ml volume containing 50mg of magnesium caudally.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged 1-7 years
* American Society of Anesthesiologists (ASA) classification I and II, undergoing hypospadias repair.

Exclusion Criteria

* Developmental delay
* Psychological or neurological disorders
* Difficult airway
* Hyperactive airway disease or children in whom caudal block was contraindicated (e.g., infection at the site of block, bleeding disorder, or abnormalities of the sacrum).

Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No