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Can Caudal Dexmedetomidine Prevents Sevoflurane Induced Emergence Agitation in Children

Primary Purpose

Delayed Emergence From Anesthesia

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Sponsored by
Suez Canal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delayed Emergence From Anesthesia focused on measuring sevoflurane emergence agitation, caudal dexmedetomidine

Eligibility Criteria

1 Year - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children aged 1-5 years old,
  • The American society of Anesthesiologists (ASA) physical status classification system between I-II of both sex who will be enrolled from March 2015 to March 2016 undergoing for lower abdominal surgeries, e.g., hernia and perineal surgeries, e.g., undescended testis and hypospadius will be included in the study.

Exclusion Criteria:

  • mental retardation, developmental delay, known allergy to any of the study drugs, congenital anomalies of spine, neurological or psychiatric illness that may be associated with improper communication, any signs of local infection in the sacrum region, any kind of cardiac conduction disorder, bleeding disorders, any previous cardiovascular disease and parental refusal.

Sites / Locations

  • Suez canal University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Traditional

Caudal dexmedetomidine

Arm Description

This will utilize the traditional method of performance of single dose caudal epidural block

In this arm, single dose caudal epidural injection will be done patients in this arm will be given dexmedetomidine (precedex 100 µg/mL parenteral preparation (Hospira ® ) 2 µg/kg in 1 ml/kg bupivacaine 0.25%

Outcomes

Primary Outcome Measures

Degree of Emergence Agitation will be evaluated-initial
using the pediatric anesthesia emergence delirium scale (PAED), Patients will be considered agitated if they had a score of 16/20 or higher

Secondary Outcome Measures

Incidence of emergence agitation at different time interval after surgery
using the pediatric anesthesia emergence delirium scale (PAED), Patients will be considered agitated if they had a score of 16/20 or higher
Emergence time
the time from the cessation of sevoflurane to the eye-opening will be noted.
Postoperative pain will be assessed, pain score will be observed and recorded at different time interval after surgery
Pain will be assessed by the pediatric observational 10-point scale "Face, Leg, Activity, Cry, Consolability (FLACC) pain score. Each category is scored on the 0-2 scale which results in a total score of 0-10. Assessment of Behavioural Score: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain Patients with pain score ≥4 will be given rescue analgesia

Full Information

First Posted
April 13, 2016
Last Updated
February 26, 2019
Sponsor
Suez Canal University
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1. Study Identification

Unique Protocol Identification Number
NCT02757495
Brief Title
Can Caudal Dexmedetomidine Prevents Sevoflurane Induced Emergence Agitation in Children
Official Title
Can Caudal Dexmedetomidine Prevents Sevoflurane Induced Emergence Agitation in Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Emergence agitation (EA) is common phenomenon in pediatric patients undergoing general anesthesia by inhalation agents. The incidence of EA was reported to range from 18% to 80%. Sevoflurane now is the inhalational anesthetic agent of choice for pediatrics, Different strategies have been suggested to decrease the incidence and severity of EA. No gold standard technique for treating EA after sevoflurane anesthesia is currently available. The main question is can caudal dexmedetomidine be used for this purpose?
Detailed Description
The purpose of this prospective comparative randomized clinical study will be to compare the effects of caudal dexmedetomidine on EA in children undergoing lower abdominal operations under general sevoflurane anesthesia. In addition, characteristics of anesthesia recovery and incidence of adverse effects will be compare. A total of (48) children aged 1-5 years old, The American society of Anesthesiologists (ASA) physical status classification system between I-II of both sex who will be enrolled from April 2016 to April 2017 undergoing for lower abdominal surgeries will be included in the study. Patients will be randomized by computer-generated random numbers in a double blinded fashion to get enrolled into 2 equal groups: Group BD patients (n = 24) will be received single dose caudal epidural analgesia using dexmedetomidine with bupivacaine, whereas Group B patients (n = 24) will be received single dose caudal epidural analgesia with bupivacaine only. The dexmedetomidine used for this study will be prepared in a 1 ml syringe wrapped in aluminum foil by an investigator who will not be involved in the anesthesia process and another 1 ml syringe filled with saline will be prepared too.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Emergence From Anesthesia
Keywords
sevoflurane emergence agitation, caudal dexmedetomidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional
Arm Type
No Intervention
Arm Description
This will utilize the traditional method of performance of single dose caudal epidural block
Arm Title
Caudal dexmedetomidine
Arm Type
Experimental
Arm Description
In this arm, single dose caudal epidural injection will be done patients in this arm will be given dexmedetomidine (precedex 100 µg/mL parenteral preparation (Hospira ® ) 2 µg/kg in 1 ml/kg bupivacaine 0.25%
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
Single dose caudal epidural injection will be done using 25 G needle. patients of Group BD will be given dexmedetomidine (precedex 100 µg/mL parenteral preparation (Hospira ® ) 2 µg/kg in 1 ml/kg bupivacaine 0.25%,
Primary Outcome Measure Information:
Title
Degree of Emergence Agitation will be evaluated-initial
Description
using the pediatric anesthesia emergence delirium scale (PAED), Patients will be considered agitated if they had a score of 16/20 or higher
Time Frame
upon awakening
Secondary Outcome Measure Information:
Title
Incidence of emergence agitation at different time interval after surgery
Description
using the pediatric anesthesia emergence delirium scale (PAED), Patients will be considered agitated if they had a score of 16/20 or higher
Time Frame
10 min ,20 min , 30 min and 60 min after surgery
Title
Emergence time
Description
the time from the cessation of sevoflurane to the eye-opening will be noted.
Time Frame
immediately postoperative
Title
Postoperative pain will be assessed, pain score will be observed and recorded at different time interval after surgery
Description
Pain will be assessed by the pediatric observational 10-point scale "Face, Leg, Activity, Cry, Consolability (FLACC) pain score. Each category is scored on the 0-2 scale which results in a total score of 0-10. Assessment of Behavioural Score: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain Patients with pain score ≥4 will be given rescue analgesia
Time Frame
immediately postoperative and every 4 hours in the first 24 hours
Other Pre-specified Outcome Measures:
Title
Side-effect-bradycardia
Description
a heart rate less than 60 beats/min
Time Frame
intraoperatively and 24 hour postoperatively
Title
Side-effect-hypotension
Description
Hypotension will be defined as a blood pressure below the 5th percentile for age and height
Time Frame
intraoperatively and 24 hour postoperatively
Title
Side-effect-respiratory depression
Description
Respiratory depression will be defined as unable to maintain oxygen saturation of ≥ 95%.
Time Frame
intraoperatively and 24 hour postoperatively
Title
Side-effect-urinary retention
Description
A urine output of less than 1 ml/kg/hr with a full bladder
Time Frame
intraoperatively and 24 hour postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children aged 1-5 years old, The American society of Anesthesiologists (ASA) physical status classification system between I-II of both sex who will be enrolled from March 2015 to March 2016 undergoing for lower abdominal surgeries, e.g., hernia and perineal surgeries, e.g., undescended testis and hypospadius will be included in the study. Exclusion Criteria: mental retardation, developmental delay, known allergy to any of the study drugs, congenital anomalies of spine, neurological or psychiatric illness that may be associated with improper communication, any signs of local infection in the sacrum region, any kind of cardiac conduction disorder, bleeding disorders, any previous cardiovascular disease and parental refusal.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghada A. Kamhawy, Lecturer
Organizational Affiliation
Suez Canal University
Official's Role
Study Director
Facility Information:
Facility Name
Suez canal University hospital
City
Ismailia
ZIP/Postal Code
41522
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Can Caudal Dexmedetomidine Prevents Sevoflurane Induced Emergence Agitation in Children

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