Clinical trial NCT02757495: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Delayed Emergence From Anesthesia
Keywords: sevoflurane emergence agitation
caudal dexmedetomidine
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 48
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Degree of Emergence Agitation will be evaluated-initial
timeFrame: upon awakening
Secondary outcomes:
measure: Incidence of emergence agitation at different time interval after surgery
timeFrame: 10 min ,20 min , 30 min and 60 min after surgery
measure: Emergence time
timeFrame: immediately postoperative
measure: Postoperative pain will be assessed, pain score will be observed and recorded at different time interval after surgery
timeFrame: immediately postoperative and every 4 hours in the first 24 hours
Other outcomes:
measure: Side-effect-bradycardia
timeFrame: intraoperatively and 24 hour postoperatively
measure: Side-effect-hypotension
timeFrame: intraoperatively and 24 hour postoperatively
measure: Side-effect-respiratory depression
timeFrame: intraoperatively and 24 hour postoperatively
measure: Side-effect-urinary retention
timeFrame: intraoperatively and 24 hour postoperatively
Locations:
city: Ismailia
country: Egypt
facility: Suez canal University hospital
Study officials:
affiliation: Suez Canal University
name: Ghada A. Kamhawy, Lecturer
role: STUDY_DIRECTOR
References: