Clinical Trial: Can Caudal Dexmedetomidine Prevents Sevoflurane Induced Emergence Agitation in Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Can Caudal Dexmedetomidine Prevents Sevoflurane Induced Emergence Agitation in Children

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 Summary: 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.
Sponsor: Suez Canal University

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • Emergence time [ Time Frame: 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 [ 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



Original Secondary Outcome:

  • 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
  • Emergence time [ Time Frame: 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 [ 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



Information By: Suez Canal University

Dates:
Date Received: April 13, 2016
Date Started: April 2016
Date Completion: May 2017
Last Updated: May 3, 2016
Last Verified: May 2016