Can Caudal Dexmedetomidine Prevents Sevoflurane Induced Emergence Agitation in Children

Delayed Emergence From Anesthesia Clinical Trial

Official title:

Can Caudal Dexmedetomidine Prevents Sevoflurane Induced Emergence Agitation in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02757495
• Other study ID #: gkamhawy
• Secondary ID: Tarek F. Tammam
• Status: Completed
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: May 2017

Study information

• Verified date: February 2019
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delayed Emergence From Anesthesia
• Emergence Delirium
• Psychomotor Agitation

Intervention

Drug:
• 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%,

Locations

Country	Name	City	State
Egypt	Suez canal University hospital	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side-effect-bradycardia	a heart rate less than 60 beats/min	intraoperatively and 24 hour postoperatively
Other	Side-effect-hypotension	Hypotension will be defined as a blood pressure below the 5th percentile for age and height	intraoperatively and 24 hour postoperatively
Other	Side-effect-respiratory depression	Respiratory depression will be defined as unable to maintain oxygen saturation of = 95%.	intraoperatively and 24 hour postoperatively
Other	Side-effect-urinary retention	A urine output of less than 1 ml/kg/hr with a full bladder	intraoperatively and 24 hour postoperatively
Primary	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	upon awakening
Secondary	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	10 min ,20 min , 30 min and 60 min after surgery
Secondary	Emergence time	the time from the cessation of sevoflurane to the eye-opening will be noted.	immediately postoperative
Secondary	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	immediately postoperative and every 4 hours in the first 24 hours