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

July 13, 2020 updated by: Hala Saad Abdel-Ghaffar, Assiut University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, Assiut,Egypt,71571
        • Assiut University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The agitation score up to 1hour postoperative.
Time Frame: 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.
first postoperative hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score assessed using the objective pain scale.
Time Frame: 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.
up to 1hour postoperative hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

March 25, 2016

First Posted (Estimate)

March 28, 2016

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssuitU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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