Use of Intraoperative Clonidine for Prevention of Postoperative Agitation in Pedriatic Anesthesia With Sevoflurane.

October 3, 2017 updated by: Alex Sandro Rolland de Souza, Professor Fernando Figueira Integral Medicine Institute
The purpose of this study is to determine efficacy of intraoperative clonidine to prevent postoperative agitation in pediatric anesthesia with sevoflurane.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • 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

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50.070-550
        • Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

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 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 2 - 12 Years.
  • Need for tonsillectomy / adenotonsillectomy.
  • Physical status of the American Society of Anesthesiologists (ASA) 1, 2 or 3.
  • Anestesia geral com sevoflurano.
  • Use of Intraoperative dipyrone, 30-50mg/Kg, IV.

Exclusion Criteria:

  • Changes in consciousness.
  • Neurological Deficit.
  • Use of another drug as medication before anesthesia.

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clonidine
Clonidine 1μg/Kg, IV, single dose, anesthesia intraoperative.
Drug: Clonidine
1μg/Kg, IV (in the vein) intraoperative. Number of Cycles: single dose.
No Intervention: No Clonidine
Usual care of Instituto de Medicina Integral Prof. Fernando Figueira.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative agitation
Time Frame: 6 hours
Postoperative agitation will be assessed by the Pediatric Anesthesia Emergence Delirium Scale (PAED).
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of postoperative agitation
Time Frame: 6 hours
Time in minutes.
6 hours
Need for post-anesthetic drugs for treatment of agitation
Time Frame: 6 hours
Use of any drugs, such as sedatives, opioids, anti-inflammatory or anti-emetic for improvement agitation.
6 hours
Any occurrence of post-anesthesia accidents: falls, bruises or disconnection of catheters
Time Frame: 6 hours
If any accident occurs in the recovery room, and postoperative (falls, bruises) disconnection of intravenous catheter or injuries.
6 hours
Drowsiness
Time Frame: 6 hours
Clinical evaluation: patient awake, awake, alert or patient under hypnosis.
6 hours
Parental satisfaction.
Time Frame: 24 hours
As parents answer the question if you are satisfied with the procedure performed, excluding other problems occurred in the hospital.
24 hours

Collaborators and Investigators

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

Sponsor

Professor Fernando Figueira Integral Medicine Institute

Investigators

  • Principal Investigator: Alex SR Souza, PhD, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
  • Study Chair: Fernando A Souza Júnior, MD, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
  • Study Chair: Tania CM Couceiro, MD, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
  • Study Chair: Ítalo GM Santos, Student, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)
  • Study Director: Luciana C Lima, PhD, Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

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

Helpful Links

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)

August 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

July 2, 2014

First Submitted That Met QC Criteria

July 2, 2014

First Posted (Estimate)

July 4, 2014

Study Record Updates

Last Update Posted (Actual)

October 4, 2017

Last Update Submitted That Met QC Criteria

October 3, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1157-8852

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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