Can Caudal Dexmedetomidine Prevents Sevoflurane Induced Emergence Agitation in Children

Phase 4

Completed

• Conditions: Delayed Emergence From Anesthesia
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT02757495
• Lead Sponsor: Suez Canal University

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-13
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-05-02
• Primary Completion: 2017-04
• Study Completion: 2017-05
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caudal dexmedetomidine	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%

Primary Outcome Measures

Name	Time	Method
Degree of Emergence Agitation will be evaluated-initial	upon awakening	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

Name	Time	Method
Incidence of emergence agitation at different time interval after surgery	10 min ,20 min , 30 min and 60 min 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	immediately postoperative	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	immediately postoperative and every 4 hours in the first 24 hours	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

Trial Locations

Locations (1)

Suez canal University hospital; 🇪🇬 Ismailia, Egypt