Recovery of TIVA vs Inhalation in Pediatric Anesthesia

Comparison of Emergence and Recovery Profile After Total Intravenous Anesthesia ( TIVA ) Vs Inhalational Anesthesia in Opioid Free Pediatric Tonsillectomy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Best Technique for Pediatric Anesthesia
• Intervention / Treatment: Drug: Propofol; Drug: Sevoflurane

Detailed Description

Complications in pediatric anesthesia can happen even in our modern hospitals with the most advanced equipment and skilled anesthesiologists.

Typical complications in pediatric anesthesia are respiratory problems , medication errors , difficulties with intravenous puncture , and pulmonal aspiration. In postoperative setting , nausea and vomiting , pain , emergence delirium can be mentioned as typical complications.

The choice of anesthetic agent and techniques can influence the occurrence of these complications and thus delay in discharge.

• Study Type: Observational
• Enrollment (Estimated): 120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children planned for ambulatory tonsillectomy from primary care clinic

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group ( s ); This group undergo anesthesia via total inhalational anesthesia using sevoflurane in induction and maintenance	Drug: Sevoflurane; 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; Other Names: Cetal suppository
Group ( p ); This group will undergo anesthesia via total intravenous anesthesia using Propofol in induction and maintenance	Drug: Propofol; 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; Other Names: Cetal suppository

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: December 10, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 27, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: TIVA vs inhalation anesthesia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No