Back to resultsThe Effect of Obesity on Recovery Profile in Children
Primary Purpose
Obesity, Childhood
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Recovery profile from general anesthesia
Sponsored by
About this trial
This is an interventional prevention trial for Obesity, Childhood
Eligibility Criteria
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
Sites / Locations
- Selcuk University Medical Faculty Hospital
Outcomes
Primary Outcome Measures
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.
Time to open eyes
The time between anesthetic discontinuation and eye opening in response to verbal stimulus or painful pinching
PACU discharge time
The time between entering and leaving the PACU.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04652193
Brief Title
The Effect of Obesity on Recovery Profile in Children
Official Title
Does Obesity Effect the Recovery Profile in Children?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
August 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Recovery profile from general anesthesia
Intervention Description
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 Outcome Measure Information:
Title
Time to spontaneous ventilation
Description
The time between anesthetic discontinuation and beginning of spontaneous ventilation.
Time Frame
up to 20 minutes
Title
LMA removal time
Description
The time between anesthetic discontinuation and LMA removal.
Time Frame
up to 25 minutes
Title
Time to open eyes
Description
The time between anesthetic discontinuation and eye opening in response to verbal stimulus or painful pinching
Time Frame
up to 30 minutes
Title
PACU discharge time
Description
The time between entering and leaving the PACU.
Time Frame
up to 45 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Selcuk University Medical Faculty Hospital
City
Konya
ZIP/Postal Code
42090
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effect of Obesity on Recovery Profile in Children
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