The Effect of Obesity on Recovery Profile in Children

Obesity, Childhood Clinical Trial

Official title:

Does Obesity Effect the Recovery Profile in Children?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04652193
• Other study ID #: 42001
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: August 15, 2021

Study information

• Verified date: June 2022
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 15, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Pediatric Obesity

Intervention

Procedure:
• Recovery profile from general anesthesia
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.

Locations

Country	Name	City	State
Turkey	Selcuk University Medical Faculty Hospital	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to spontaneous ventilation	The time between anesthetic discontinuation and beginning of spontaneous ventilation.	up to 20 minutes
Primary	LMA removal time	The time between anesthetic discontinuation and LMA removal.	up to 25 minutes
Primary	Time to open eyes	The time between anesthetic discontinuation and eye opening in response to verbal stimulus or painful pinching	up to 30 minutes
Primary	PACU discharge time	The time between entering and leaving the PACU.	up to 45 minutes