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Comparison of Caudal Block Versus Dexmedetomidine Infusion in Pediatric Patients Undergoing Hypospadias Repair Surgery

Primary Purpose

Dexmedetomidine Infusion, Pediatric, Hypospadias Repair Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
caudal block
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dexmedetomidine Infusion

Eligibility Criteria

2 Years - 12 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. male children
  2. american society of aneasthesia physical status grade I &II
  3. patients aged from 2 years to 12 years
  4. patients will undergoing hypospadias repair surgery

Exclusion Criteria:

  1. history or evidence of infection at the back
  2. allergy to the study drugs
  3. bleeding/coagulation disorder
  4. developmental delay
  5. septic patients
  6. neurological or spinal diseases.

Sites / Locations

  • Ahmed AbdelrahmanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control group

caudal group

dexmetomidine group

Arm Description

On arrival to operating room, Noninvasive monitors, such as electrocardiography, noninvasive blood pressure (NIBP), oxygen saturation (SpO2), will be attached and baseline parameters such as heart rate, mean arterial pressure, and peripheral oxygen saturation will be recorded . General anesthesia will be induced with O2/sevo (FiO2 = 1 /sevoflurane 8% MAC), cis-atracurium 0.1 mg/kg iv, +/- fentanyl 1 mcg/kg iv. Trachea will be intubated with an appropriate sized, endotracheal tube and maintenance of anesthesia by O2/Air (FiO2 = 0.4), sevoflurane 2% MAC. Dexamethasone 0.15 mg/kg iv will be given as PONV prophylaxis. Increments of fentanyl 0.5 mcg/kg iv and cis-atracurium 0.03 mg/kg iv will be given according to hemodynamics and capnography.

After negative aspiration of blood or cerebrospinal fluid, 2 mg/ kg of bupivacaine at concentration of 0.5% (volume 0.5ml/kg) was given as per the group assigned, then the site of injection was dressed, and the patient was turned supine.

Children in this group will be received (1 mcg/kg IV over 10 minutes followed by 0.5 mcg/kg/hr) with a suggested maximum dose of 2 mcg/kg.of dexmedetomidine is available in a 100 mcg/mL concentration in a 2 mL preservative-free vial. It may be prepared as a 2 to 4 mcg/mL solution using normal saline

Outcomes

Primary Outcome Measures

quality of recovery of the studied patients
quality of recovery of the studied patients using modified objective pain score
quality of recovery of the studied patients
change in quality of recovery of the studied patients using modified objective pain score

Secondary Outcome Measures

concentration of required postoperative analgesic
concentration of postoperative analgesic
concentration of required postoperative analgesic
concentration of required postoperative analgesic
concentration of required postoperative sedation
concentration of required postoperative sedation
concentration of required postoperative sedation
concentration of required postoperative sedation
number of patients developed perioperative complications.
number of patients developed perioperative complications
number of patients developed perioperative complications.
number of patients developed perioperative complications

Full Information

First Posted
March 27, 2020
Last Updated
June 10, 2020
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04331418
Brief Title
Comparison of Caudal Block Versus Dexmedetomidine Infusion in Pediatric Patients Undergoing Hypospadias Repair Surgery
Official Title
Comparison of Caudal Block Versus Dexmedetomidine Infusion in Pediatric Patients Undergoing Hypospadias Repair Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2020 (Actual)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
October 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Pain is one of the most misunderstood, underdiagnosed, and untreated medical problems, particularly in children. New Joint Commission on Accreditation of Health Care Organization regards pain as fifth vital sign and requires caregivers to regularly assess pain. Inadequate pain relief during childhood may have long-term negative effects including harmful neuroendocrine responses disrupted eating and sleep cycles and increased pain perception during subsequent painful experiences. Also, postoperative pain can result in an uncooperative and restless child. Hence, it is preferable to prevent the onset of pain rather than to relieve its existence. Various multimodal techniques have been designed for pediatric pain relief. These include both systemic and regional analgesia. The most commonly used regional technique is caudal epidural block. Advantages of the caudal block are smoother recovery with less distress behavior, early ambulation, decreased the risk of chest infections, decreased postoperative analgesic requirements, and early discharge. In our culture; considerable number of parents still refuses caudal anesthesia fearing from the rare neurological sequelae may occur. This the motive for searching for parenteral surrogate gives clear headed recovery resembles regional analgesia. Dexmedetomidine is an alpha 2 agonist which has sedative, analgesic, and opioid-sparing effect. It prolongs the duration of analgesia by its local vasoconstrictive effect and by increasing the potassium conductance in A-delta and C-fibers. It also exerts its analgesic action centrally via systemic absorption or by diffusion into the cerebrospinal fluid and reaches alpha 2 receptors in the superficial laminae of the spinal cord and brainstem or indirectly activating spinal cholinergic neurons. The sedative effects of dexmedetomidine are mostly due to stimulation of the alpha 2 adrenoceptor in the locus coeruleus

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexmedetomidine Infusion, Pediatric, Hypospadias Repair Surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
On arrival to operating room, Noninvasive monitors, such as electrocardiography, noninvasive blood pressure (NIBP), oxygen saturation (SpO2), will be attached and baseline parameters such as heart rate, mean arterial pressure, and peripheral oxygen saturation will be recorded . General anesthesia will be induced with O2/sevo (FiO2 = 1 /sevoflurane 8% MAC), cis-atracurium 0.1 mg/kg iv, +/- fentanyl 1 mcg/kg iv. Trachea will be intubated with an appropriate sized, endotracheal tube and maintenance of anesthesia by O2/Air (FiO2 = 0.4), sevoflurane 2% MAC. Dexamethasone 0.15 mg/kg iv will be given as PONV prophylaxis. Increments of fentanyl 0.5 mcg/kg iv and cis-atracurium 0.03 mg/kg iv will be given according to hemodynamics and capnography.
Arm Title
caudal group
Arm Type
Experimental
Arm Description
After negative aspiration of blood or cerebrospinal fluid, 2 mg/ kg of bupivacaine at concentration of 0.5% (volume 0.5ml/kg) was given as per the group assigned, then the site of injection was dressed, and the patient was turned supine.
Arm Title
dexmetomidine group
Arm Type
Experimental
Arm Description
Children in this group will be received (1 mcg/kg IV over 10 minutes followed by 0.5 mcg/kg/hr) with a suggested maximum dose of 2 mcg/kg.of dexmedetomidine is available in a 100 mcg/mL concentration in a 2 mL preservative-free vial. It may be prepared as a 2 to 4 mcg/mL solution using normal saline
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
1 mcg/kg IV over 10 minutes followed by 0.5 mcg/kg/hr
Intervention Type
Procedure
Intervention Name(s)
caudal block
Intervention Description
After negative aspiration of blood or cerebrospinal fluid, 2 mg/ kg of bupivacaine at concentration of 0.5% (volume 0.5ml/kg) was given as per the group assigned, then the site of injection was dressed, and the patient was turned supine.
Primary Outcome Measure Information:
Title
quality of recovery of the studied patients
Description
quality of recovery of the studied patients using modified objective pain score
Time Frame
in immediate recovery from aneasthesia at postaneathetic care unit up to 2 hours
Title
quality of recovery of the studied patients
Description
change in quality of recovery of the studied patients using modified objective pain score
Time Frame
from discharge from PACU up to 6 hours in the surgical ward
Secondary Outcome Measure Information:
Title
concentration of required postoperative analgesic
Description
concentration of postoperative analgesic
Time Frame
in immediate recovery from aneasthesia up to 2 hours at postaneathetic care unit
Title
concentration of required postoperative analgesic
Description
concentration of required postoperative analgesic
Time Frame
from discharge from PACU up to 6 hours in the surgical ward
Title
concentration of required postoperative sedation
Description
concentration of required postoperative sedation
Time Frame
in immediate recovery from aneasthesia up to 2 hours at postaneathetic care unit
Title
concentration of required postoperative sedation
Description
concentration of required postoperative sedation
Time Frame
from discharge from PACU up to 6 hours in the surgical ward
Title
number of patients developed perioperative complications.
Description
number of patients developed perioperative complications
Time Frame
in immediate recovery from aneasthesia up to 2 hours at postaneathetic care unit
Title
number of patients developed perioperative complications.
Description
number of patients developed perioperative complications
Time Frame
from discharge from PACU up to 6 hours in the surgical ward

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: male children american society of aneasthesia physical status grade I &II patients aged from 2 years to 12 years patients will undergoing hypospadias repair surgery Exclusion Criteria: history or evidence of infection at the back allergy to the study drugs bleeding/coagulation disorder developmental delay septic patients neurological or spinal diseases.
Facility Information:
Facility Name
Ahmed Abdelrahman
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmed abdelrahman, MD
Phone
01224778144
Email
ahmed.abdelrahman@med.tanta.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Caudal Block Versus Dexmedetomidine Infusion in Pediatric Patients Undergoing Hypospadias Repair Surgery

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