Can Caudal Dexmedetomidine Prevents Sevoflurane Induced Emergence Agitation in Children

NCT02757495 | Completed Phase 4

• 2 other identifiers: gkamhawyTarek F. Tammam
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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?

Conditions

Delayed Emergence From Anesthesia

Keywords

sevoflurane emergence agitation; caudal dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Incidence of emergence agitation at different time interval after surgery

  10 min ,20 min , 30 min and 60 min after surgery

• Emergence time

  immediately postoperative

• 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

Other Outcomes (4)

• Side-effect-bradycardia

  intraoperatively and 24 hour postoperatively

• Side-effect-hypotension

  intraoperatively and 24 hour postoperatively

• Side-effect-respiratory depression

  intraoperatively and 24 hour postoperatively

Study Arms (2)

Traditional

NO INTERVENTION

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

Caudal dexmedetomidine

EXPERIMENTAL

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%

Drug: Dexmedetomidine

Interventions

Dexmedetomidine 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%,

Also known as: Precedex

Caudal dexmedetomidine

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez canal University hospital

Ismailia, 41522, Egypt

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ghada A. Kamhawy, Lecturer

  Suez Canal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia,faculty of medicine, suez canal university

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: May 2, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

EG (1)