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Completed

NCT Number: NCT02181543

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

The purpose of this study is to determine efficacy of intraoperative clonidine to prevent postoperative agitation in pediatric anesthesia with sevoflurane.

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Key information

Conditions

Is an Only Child Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Dyskinesias Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

Recife, Pernambuco, 50.070-550, Brazil

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Clonidine

Drug

1μg/Kg, IV (in the vein) intraoperative. Number of Cycles: single dose.

Primary outcomes

  1. Postoperative agitation

    Time frame: 6 hours

    Postoperative agitation will be assessed by the Pediatric Anesthesia Emergence Delirium Scale (PAED).

Secondary outcomes

  1. Duration of postoperative agitation

    Time frame: 6 hours

    Time in minutes.

  2. 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.

  3. 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.

  4. Drowsiness

    Time frame: 6 hours

    Clinical evaluation: patient awake, awake, alert or patient under hypnosis.

  5. 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.

Sponsors and collaborators

Lead sponsor

Professor Fernando Figueira Integral Medicine Institute

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 4, 2014
Registry last updated
Oct 4, 2017

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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