Recovery of TIVA vs Inhalation in Pediatric Anesthesia

NCT06215833 | Unknown

• 1 other identifier: TIVA vs inhalation anesthesia
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

Compare recovery profile from TIVA and that of total inhalational anesthesia in ambulatory pediatric tonsillectomy and which strategy is more safe and less cost and more smooth in pediatric anesthesia.

Conditions

Best Technique for Pediatric Anesthesia

Outcome Measures

Primary Outcomes (7)

• level of consciousness score

  * Awake =2 * Arousal with minimal stimulation =1 * Responsive only to tactile stimulation =0 * No score 0 is required \& High score mean more safe and better method of anesthesia .

  About 20 minutes after stopping anesthesia and emergence from anesthesia begin

• physical activity score

  * Able to move on command =2 * Some weakness in movement = 1 * Unable to voluntarily move = 0 * No score 0 is required \& High score mean more safe and better method of anesthesia .

  About 20 minutes after stopping anesthesia and emergence from anesthesia begin

• hemodynamic stability score

  * Blood pressure \< 15% of baseline MAP value =2 * Blood pressure 15%-30% of baseline MAP value =1 * Blood pressure \< 30% below baseline MAP value =0 * No score 0 is required \& High score mean more safe and better method of anesthesia .

  About 20 minutes after stopping anesthesia and emergence from anesthesia begin

• respiratory stability score

  * Able to breathe deeply = 2 * Tachypnea with good coughs =1 * Dyspneic with weak cough = 0 * No score 0 is required \& High score mean more safe and better method of anesthesia .

  About 20 minutes after stopping anesthesia and emergence from anesthesia begin

• Oxygen saturation score

  * Maintain value \> 90% on room air = 2 * Requires supplemental O2 to maintain value \> 90% = 1 * So2 \< 90% with supplemental O2 = 0 * No score 0 is required \& High score mean more safe and better method of anesthesia .

  About 20 minutes after stopping anesthesia and emergence from anesthesia begin

• post operative pain score

  * None or mild = 2 * Moderate to severe pain controlled =1 * Persistent severe pain = 0 * No score 0 is required \& High score mean more safe and better method of anesthesia .

  About 20 minutes after stopping anesthesia and emergence from anesthesia begin

• post operative emetic score

  * None or mild nausea with no active vomiting = 2 * Transient vomiting =1 * Persistent moderate to severe nausea and vomiting=0 * No score 0 is required \& High score mean more safe and better method of anesthesia .

  About 20 minutes after stopping anesthesia and emergence from anesthesia begin

Study Arms (2)

Group ( p )

This group will undergo anesthesia via total intravenous anesthesia using Propofol in induction and maintenance

Drug: Propofol

Group ( s )

This group undergo anesthesia via total inhalational anesthesia using sevoflurane in induction and maintenance

Drug: Sevoflurane

Interventions

Propofol DRUG

All children will undergo anesthesia via Propofol bolus injection in induction then Propofol infusion in maintenance of anesthesia and will be given after total recovery, Cetal suppositories as postoperative analgesia

Also known as: Cetal suppository

Group ( p )

Sevoflurane DRUG

All children will undergo anesthesia via Sevoflurane will be given during induction then through maintenance of anesthesia and will be given after total recovery, Cetal suppositories as post operative analgesia

Also known as: Cetal suppository

Group ( s )

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children planned for ambulatory tonsillectomy from primary care clinic

You may qualify if:

• child between 4 to 10 years
• without co morbidity
• ASA score 1
• mallampati score 1 and 2

You may not qualify if:

• child below 4 years and above 10 years
• child with co morbidity
• ASA score above 1
• mallampati score 3 and 4

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: January 22, 2024
• Study Start: January 30, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL