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Completed

NCT Number: NCT03807011

Emergence Agitation in Pediatric Strabismus Surgery

This study was performed to assess the effects of continuous remifentanil infusion and single bolus administration of fentanyl on the incidence of emergence agitation in pediatrics undergoing strabismus surgery.

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Key information

Conditions

Emergence Agitation Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eun kyung Choi, Daegu, Korea (the Republic Of), South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients undergoing elective subumbilical surgery,
  • physical status was American Society of Anesthesiologists (ASA) class 1 or 2

Exclusion criteria

  • history of airway problem,
  • upper respiratory tract infection within 2 weeks,
  • developmental delay,
  • neurological or psychological disease,
  • history of allergy to the drugs in our protocol were excluded in this study.

Treatment and study plan

Fentanyl group

Drug

fentanyl 2 μg/kg

Remifentanil group

Drug

remifentanil 0.2 μg/kg/min

Primary outcomes

  1. incidence of postoperative agitation

    Time frame: 5 minutes in the recovery room

    0=none; 1=occur

  2. incidence of postoperative agitation

    Time frame: 30 minutes in the recovery room

    0=none; 1=occur

  3. severity of postoperative agitation

    Time frame: 5 minutes in the recovery room

    Four-point agitation scale (0=calm; 1=not calm but could easily become calmed; 3=not easily calmed, moderately agitated and restless; 4=combative, excited, or disoriented)

  4. severity of postoperative agitation

    Time frame: 30 minutes in the recovery room

    Four-point agitation scale (0=calm; 1=not calm but could easily become calmed; 3=not easily calmed, moderately agitated and restless; 4=combative, excited, or disoriented)

Sponsors and collaborators

Lead sponsor

Yeungnam University College of Medicine

Other

Registry information

Official study title

The Effects of Remifentanil and Fentanyl on Emergence Agitation in Pediatric Strabismus Surgery

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 16, 2019
Registry last updated
Jan 23, 2019

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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