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Trial record 4 of 8 for:    "Hypospadias" | "Neurotransmitter Agents"

Caudal Dexmedetomidine Analgesia in Pediatrics .

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ClinicalTrials.gov Identifier: NCT03791879
Recruitment Status : Not yet recruiting
First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Abd Latif Ghanim, Mansoura University

Brief Summary:
Dexmedetomidine (DEXM) is a highly selective α2‐adrenoceptor agonist that has been used increasingly in pediatric anesthesia. This prospective double blinded randomized comparative study is designed to evaluate the analgesic effect of caudal increasing doses of DEXM 0.5 , 1 , 1.5 , 2µg/kg combined with Levobupivacaine (Levob) 0.125% (ED95% =125%=least effective concentration) in providing pain relief over a 24‐h period and lowest surgical stress peak. Study hypothesis: Levobupivacaine 0.125 %( ED95) combined with different increasing doses of dexamedatomedine >1 µg/kg could not add more analgesic & stress response obtundation outcome, but increase side effects (sedation and hemodynamic depression). The peak cortisol level during urology surgery was at the end of the 1st postoperative (PO) hour. Aim of the Study: To detect the optimal analgesic and safe caudal adjuvant DEXM dose associated with the least side effects& stress response modulation, guided by PO Cortisol peak difference in between the study groups during pediatric hypospadias surgery.

Condition or disease Intervention/treatment Phase
164 Boys for Hypospadias Surgery Under General Anesthesia With Caudal Block Drug: Caudal dexamedatomidine analgesia Not Applicable

Detailed Description:

Background: Dexmedetomidine (DEXM) is a highly selective α2‐adrenoceptor agonist that has been used increasingly in pediatric anesthesia. This prospective double blinded randomized comparative study is designed to evaluate the analgesic effect of caudal increasing doses of DEXM 0.5 , 1 , 1.5 , 2µg/kg combined with Levobupivacaine (Levob) 0.125% (ED95% =125%=least effective concentration) in providing pain relief over a 24‐h period and lowest surgical stress peak. Study hypothesis: Levobupivacaine 0.125 %( ED95) combined with different increasing doses of dexamedatomedine >1 µg/kg could not add more analgesic & stress response obtundation outcome, but increase side effects (sedation and hemodynamic depression).The peak cortisol level during urology surgery was at the end of the 1st postoperative (PO) hour. Aim of the Study: To detect the optimal analgesic and safe caudal adjuvant DEXM dose associated with the least side effects& stress response modulation, guided by PO Cortisol peak difference in between the study groups during pediatric hypospadias surgery.

Optimal effective dose defined as; the least caudal DEXM dose which produce the best analgesic outcome [least time to 1st analgesic request and lowest rescue analgesic dose (24Hs)] associated with the least stress response (cortisol PO. first One hour peak), least PO sedation, and hemodynamic stability IO. &PO. HR & MAP. The peak cortisol level during urology surgery was at the end of the 1st postoperative (PO) hour.

. Material & Methods A prospective randomized double blinded (drug injector and PO assessor) comparative study will be conducted in Mansoura university hospital after obtaining ethics committee approval and written informed parental consent 164 boys (age 1-6 years, ASA I) scheduled for hypospadias surgery. Exclusion criteria; (Operative time exceeding 3 hours, bodyweight >25kg, bleeding diathesis, infection at the site of block, pre‐existing neurological or spinal disease or abnormalities of the sacrum, inability to palpate the sacral hiatus by anatomic landmark palpation technique) or those with a history of allergic reactions to local anesthetics were excluded from the study. Patients will fast for solids 6h and water and 2 hours before surgery. After Patient Preoperative preparation, General anesthesia induction, caudal block and caudal drug injection (Levob plus DEXM) bolus will be injected according to each group as follow;

  • Group A will take Caudal Levob 0. 125%+ DEXM 0.5µg/kg.
  • Group B will take Caudal Levob 0.125%+ DEXM 1µg/kg.
  • Group C will take Caudal Levob 0. 125%+ DEXM 1.5 µg/kg.
  • Group D will take Caudal Levob 0. 125%+ DEXM 2µg/kg.

The study outcomes recording:

1ry outcome: Time to (1st analgesic request OPS >4). Secondary outcome: Total 24hours PO. Rescue analgesic dose IM pethidine 0.5mg/kg [2,3] based on local policy and protocol, Patients demographic data [age, weight, end tidal Sevoflurane (volume %) prior starting skin closure, intraoperative fentanyl total dose, recovery time (time from discontinuation of anesthesia to spontaneous eye opening)], Serum Cortisol level at basal before anesthesia and 1hour postoperative in between groups [1] , Apnea incidence (NO&%), and desaturation (NO&%), Objective pain score, Sedation score, Behavioral score for Agitation assessment, and Modified bromage score (residual Lower limb muscle weakness) recorded every 15 minutes for 1st hour then every 30 minutes for next 3 PO hours then at next 6th, 12th, 18th, 24th PO hours, hemodynamics, HR&SBP the incidence of bradycardia and hypotension per 50% percentile. Recorded every 10 minutes IO for maximum operative time 3 hours and every 30 min PO for next 2h in the recovery room until the child was discharged to the ward.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Analgesic Effectiveness and Safety of Upgraded Caudal Dexmedetomidine Doses in Pediatric Hypospadias Surgery.
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: • Group A will take Caudal Levob 0. 125%+ DEXM 0.5µg/k Drug: Caudal dexamedatomidine analgesia

Technique performance (Caudal block): classical technique; palpation, identification and puncture with the patients in the lateral position (permits easy access to the airway under general anesthesia) using a 22‐G short‐beveled needle under sterile conditions advancing needle pierces the sacrococcygeal ligament.

After needle insertion, pre-calculated volume of Levob plus DEXM bolus was injected as follow; Group A Caudal Levob 0.125%+ DEXM 0.5µg/kg. Group B Caudal Levob 0.125%+ DEXM 1µg/kg. Group C Caudal Levob 0.125%+ DEXM 1. 5 µg/kg. Group D Caudal Levob 0.125%+ DEXM 2µg/kg.


Active Comparator: • Group B will take Caudal Levob 0.125%+ DEXM 1µg/kg. Drug: Caudal dexamedatomidine analgesia

Technique performance (Caudal block): classical technique; palpation, identification and puncture with the patients in the lateral position (permits easy access to the airway under general anesthesia) using a 22‐G short‐beveled needle under sterile conditions advancing needle pierces the sacrococcygeal ligament.

After needle insertion, pre-calculated volume of Levob plus DEXM bolus was injected as follow; Group A Caudal Levob 0.125%+ DEXM 0.5µg/kg. Group B Caudal Levob 0.125%+ DEXM 1µg/kg. Group C Caudal Levob 0.125%+ DEXM 1. 5 µg/kg. Group D Caudal Levob 0.125%+ DEXM 2µg/kg.


Active Comparator: • Group C will take Caudal Levob 0. 125%+ DEXM 1.5 µg/ Drug: Caudal dexamedatomidine analgesia

Technique performance (Caudal block): classical technique; palpation, identification and puncture with the patients in the lateral position (permits easy access to the airway under general anesthesia) using a 22‐G short‐beveled needle under sterile conditions advancing needle pierces the sacrococcygeal ligament.

After needle insertion, pre-calculated volume of Levob plus DEXM bolus was injected as follow; Group A Caudal Levob 0.125%+ DEXM 0.5µg/kg. Group B Caudal Levob 0.125%+ DEXM 1µg/kg. Group C Caudal Levob 0.125%+ DEXM 1. 5 µg/kg. Group D Caudal Levob 0.125%+ DEXM 2µg/kg.


Active Comparator: • Group D will take Caudal Levob 0. 125%+ DEXM 2µg/kg. Drug: Caudal dexamedatomidine analgesia

Technique performance (Caudal block): classical technique; palpation, identification and puncture with the patients in the lateral position (permits easy access to the airway under general anesthesia) using a 22‐G short‐beveled needle under sterile conditions advancing needle pierces the sacrococcygeal ligament.

After needle insertion, pre-calculated volume of Levob plus DEXM bolus was injected as follow; Group A Caudal Levob 0.125%+ DEXM 0.5µg/kg. Group B Caudal Levob 0.125%+ DEXM 1µg/kg. Group C Caudal Levob 0.125%+ DEXM 1. 5 µg/kg. Group D Caudal Levob 0.125%+ DEXM 2µg/kg.





Primary Outcome Measures :
  1. Time to (1st analgesic request objective pain score (OPS) ≥4) [ Time Frame: Basal (0) till 24 hours. ]
    time from full recovery till child express moderate pain OPS 4 and ask for the first analgesic dose



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 8 Years   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 164 boys (age 1-8 years, ASA I) scheduled for hypospadias surgery

Exclusion Criteria:

  • Operative time exceeding 3 hours, bodyweight >25kg, bleeding diathesis, infection at the site of block, pre‐existing neurological or spinal disease or abnormalities of the sacrum, inability to palpate the sacral hiatus by anatomic landmark palpation technique) or those with a history of allergic reactions to local anesthetics were excluded from the study

Information from the National Library of Medicine

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): NCT03791879


Contacts
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Contact: mohamed A Ghanem, A. Professor 00201067883998 mohamed.abdel_latif@yahoo.com

Sponsors and Collaborators
Mansoura University
Investigators
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Study Chair: mohamed A Ghanem, A professor Mansoura Univeristy

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Responsible Party: Mohamed Abd Latif Ghanim, Associate Professor os anesthesia ICU & Pain medicine., Mansoura University
ClinicalTrials.gov Identifier: NCT03791879     History of Changes
Other Study ID Numbers: MFM IR.18.11.322 - 2018/11/11
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Abd Latif Ghanim, Mansoura University:
Caudal
Dexmedetomidine
Levobupivacaine
hypospadias
Additional relevant MeSH terms:
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Hypospadias
Neurotransmitter Agents
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action