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Transbucal Dexmedetomidine for Prevention of Sevoflurane Emergence Agitation in Pre-school Children

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT02720705
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
30
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the efficacy of transbucal dexmedetomidine given in preschool children undergoing tonsillectomy operations in the prevention sevoflurane agitation.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

Agitation during the emergence from general anesthesia is a great post-operative problem that often injures the patients themselves and requires the medical staff to restrain and calm them. The predisposing factors for emergence agitation include anesthesia, operation, and patient. Sevoflurane anesthesia results in higher incidence of emergence agitation than halothane, because of the rapid emergence, and its effects on central nervous system inducing convulsion and post-operative behavioral changes. The otorhinolaryngologic and ophthalmologic surgeries, post-operative pain, young age, pre-operative anxiety, no past surgical history, and adjustment disorder of patients are risk factors.

Dexmedetomidine (DEX), a selective α (2)-adrenoreceptor agonist. Intravenous DEX used after induction of anesthesia reduced sevoflurane-associated EA and postoperative pain in pediatric ambulatory surgery.

The investigators designed this study to prove the efficacy of oral dexmedetomidine a selective α (2)-adrenoreceptor agonist, on emergence agitation (EA), recovery profiles, and parents' satisfaction after sevoflurane anesthesia in tonsillectomy.

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Transbucal Dexmedetomidine for the Prevention of Emergence Agitation After Sevoflurane Anaesthesia in Pre-school Children
Actual Study Start Date :
May 1, 2016
Actual Primary Completion Date :
Oct 1, 2018
Actual Study Completion Date :
Nov 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: DEX I

active comparator receive 0.5µg/kg dexmedetomidine orally half an hour before operation

Drug: Dexmedetomidine
oral dexmedetomidine
Other Names:
  • precedex

    		•
    Placebo Comparator: Saline Control

    2ml oral 0.9%saline half an hour before operation

    Drug: saline
    2ml 0.9% saline administered orally half an hour before induction of anesthesia
    Other Names:
  • 0.9% saline

    		•
    Active Comparator: DEX II

    active comparator receive,1µg/kg dexmedetomidine orally half an hour before operation

    Drug: Dexmedetomidine
    oral dexmedetomidine
    Other Names:
  • precedex

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The agitation score up to 1hour postoperative. [first postoperative hour]

      Agitation intensity will be assessed postoperatively by using agitation score 0= child is asleep. awake/calm =1. irritable/ consolable cry =2. inconsolable cry =3.the child is agitating and thrashing and restlessness Emergence delirium ≥ 3 agitation score will be performed in the following time points; at 5 min postoperative,10 min, 15, 30, 45, 60 min.

    Secondary Outcome Measures

    1. Pain score assessed using the objective pain scale. [up to 1hour postoperative hour]

      Pain intensity will be assessed postoperatively by using the objective pain scale. objective pain scale assessments will be performed in the following time points; at 5 min postoperative, 10 min, 15, 30, 45, 60 min.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ASA physical status I-II patients

    • aged 2-6 years

    • patient scheduled for elective tonsillectomy due to recurrent

    • chronic tonsillitis

    Exclusion Criteria:

    • patients with known hypersensitivity to medication drugs

    • coagulation disorders

    • thrombocytopenia

    • significant cardiac

    • renal

    • pulmonary

    • hepatic disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university hospitals Assiut Egypt Assiut,Egypt,71571

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Halla s Abdel-Ghaffar Abdel-Ghaffar, MD, assisstant professor in anesthesia and intensive care departement,faculty of medicine,Assiut university,Egypt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hala Saad Abdel-Ghaffar, MD, Assiut University
    ClinicalTrials.gov Identifier:
    NCT02720705
    Other Study ID Numbers:
    • AssuitU
    First Posted:
    Mar 28, 2016
    Last Update Posted:
    Jul 14, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Hala Saad Abdel-Ghaffar, MD, Assiut University
    sevoflurane emergence agitation
    Additional relevant MeSH terms:
    Psychomotor Agitation
    Emergence Delirium
    Dexmedetomidine

    Study Results

    No Results Posted as of Jul 14, 2020