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OpenTrials
Completed

NCT Number: NCT04652193

The Effect of Obesity on Recovery Profile in Children

It is planned to investigate whether obesity affects the recovery profile after anesthesia in pediatric patients. To evaluate recovery profile, time to spontaneous ventilation (the time between anesthetic discontinuation and beginning of spontaneous ventilation), LMA removal time (the time between anesthetic discontinuation and LMA removal), open eyes (the time between anesthetic discontinuation and eye opening in response to verbal stimulus or painful pinching), and PACU discharge will be also noted.

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Key information

Conditions

Obesity, Childhood Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University Medical Faculty Hospital

Konya, 42090, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA physical status I and II
  • Routine surgery under general anesthesia

Exclusion criteria

  • Any known cerebrovascular disease
  • Long- or short-term (within the previous 24 hours) intake of any drug acting in the central nervous system
  • The patients bypassing the recovery room

Treatment and study plan

Recovery profile from general anesthesia

Procedure

It includes the phases during recovery from general anesthesia: Time to spontaneous ventilation, Laryngeal Mask Airway (LMA) removal time, open eyes, and Post-Anesthesia Care Unit (PACU) discharge.

Primary outcomes

  1. Time to spontaneous ventilation

    Time frame: up to 20 minutes

    The time between anesthetic discontinuation and beginning of spontaneous ventilation.

  2. LMA removal time

    Time frame: up to 25 minutes

    The time between anesthetic discontinuation and LMA removal.

  3. Time to open eyes

    Time frame: up to 30 minutes

    The time between anesthetic discontinuation and eye opening in response to verbal stimulus or painful pinching

  4. PACU discharge time

    Time frame: up to 45 minutes

    The time between entering and leaving the PACU.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

Does Obesity Effect the Recovery Profile in Children?

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 3, 2020
Registry last updated
Jul 5, 2022

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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