NCT04652193

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2021

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

7 months

First QC Date

November 20, 2020

Last Update Submit

June 29, 2022

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (4)

  • Time to spontaneous ventilation

    The time between anesthetic discontinuation and beginning of spontaneous ventilation.

    up to 20 minutes

  • LMA removal time

    The time between anesthetic discontinuation and LMA removal.

    up to 25 minutes

  • Time to open eyes

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

    up to 30 minutes

  • PACU discharge time

    The time between entering and leaving the PACU.

    up to 45 minutes

Interventions

Recovery profile from general anesthesiaPROCEDURE

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.

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University Medical Faculty Hospital

Konya, 42090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 20, 2020

First Posted

December 3, 2020

Study Start

January 1, 2021

Primary Completion

August 1, 2021

Study Completion

August 15, 2021

Last Updated

July 5, 2022

Record last verified: 2022-06

Locations

TU(1)