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NCT Number: NCT02757495

Can Caudal Dexmedetomidine Prevents Sevoflurane Induced Emergence Agitation in Children

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?

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Key information

Conditions

Delayed Emergence From Anesthesia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Suez canal University hospital

Ismailia, 41522, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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%,

Other names: Precedex

Primary outcomes

  1. Degree of Emergence Agitation will be evaluated-initial

    Time frame: 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 outcomes

  1. Incidence of emergence agitation at different time interval after surgery

    Time frame: 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

  2. Emergence time

    Time frame: immediately postoperative

    the time from the cessation of sevoflurane to the eye-opening will be noted.

  3. Postoperative pain will be assessed, pain score will be observed and recorded at different time interval after surgery

    Time frame: 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

Other outcomes

  1. Side-effect-bradycardia

    Time frame: intraoperatively and 24 hour postoperatively

    a heart rate less than 60 beats/min

  2. Side-effect-hypotension

    Time frame: intraoperatively and 24 hour postoperatively

    Hypotension will be defined as a blood pressure below the 5th percentile for age and height

  3. Side-effect-respiratory depression

    Time frame: intraoperatively and 24 hour postoperatively

    Respiratory depression will be defined as unable to maintain oxygen saturation of ≥ 95%.

  4. Side-effect-urinary retention

    Time frame: intraoperatively and 24 hour postoperatively

    A urine output of less than 1 ml/kg/hr with a full bladder

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 2, 2016
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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