Can Caudal Dexmedetomidine Prevents Sevoflurane Induced Emergence Agitation in Children

NCT ID: NCT02757495

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-05-31

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.

Conditions

Delayed Emergence From Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Traditional

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Caudal dexmedetomidine

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%

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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%,

Interventions

Dexmedetomidine

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%,

Intervention Type: DRUG

Other Intervention Names

Precedex

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Ghada A.Kamhawy

lecturer of anesthesia,faculty of medicine, suez canal university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ghada A. Kamhawy, Lecturer

Role: STUDY_DIRECTOR

Suez Canal University

Locations

Suez canal University hospital

Ismailia, , Egypt

Countries

Egypt

Other Identifiers

Tarek F. Tammam

Identifier Type: OTHER

Identifier Source: secondary_id

gkamhawy

Identifier Type: -

Identifier Source: org_study_id