Can Caudal Dexmedetomidine Prevents Sevoflurane Induced Emergence Agitation in Children

S

Suez Canal University

Status and phase

Completed
Phase 4

Conditions

Delayed Emergence From Anesthesia

Treatments

Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT02757495
gkamhawy
Tarek F. Tammam (Other Identifier)

Details and patient eligibility

About

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?

Full 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.

Enrollment

48 patients

Sex

All

Ages

1 to 5 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

48 participants in 2 patient groups

Traditional
No Intervention group
Description:
This will utilize the traditional method of performance of single dose caudal epidural block
Caudal dexmedetomidine
Experimental group
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%
Treatment:
Drug: Dexmedetomidine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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