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Clinical Trials/NCT06215833
NCT06215833
Not yet recruiting
Not Applicable

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

Assiut University0 sites120 target enrollmentJanuary 30, 2024

Overview

Phase
Not Applicable
Intervention
Propofol
Conditions
Best Technique for Pediatric Anesthesia
Sponsor
Assiut University
Enrollment
120
Primary Endpoint
physical activity score
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 30, 2024
End Date
December 30, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mahmoud Sayed

Principal Investigator

Assiut University

Eligibility Criteria

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

Arms & Interventions

Group ( p )

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

Intervention: Propofol

Group ( s )

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

Intervention: Sevoflurane

Outcomes

Primary Outcomes

physical activity score

Time Frame: About 20 minutes after stopping anesthesia and emergence from anesthesia begin

* 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 .

hemodynamic stability score

Time Frame: About 20 minutes after stopping anesthesia and emergence from anesthesia begin

* 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 .

respiratory stability score

Time Frame: About 20 minutes after stopping anesthesia and emergence from anesthesia begin

* 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 .

level of consciousness score

Time Frame: About 20 minutes after stopping anesthesia and emergence from anesthesia begin

* 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 .

post operative pain score

Time Frame: About 20 minutes after stopping anesthesia and emergence from anesthesia begin

* 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 .

Oxygen saturation score

Time Frame: About 20 minutes after stopping anesthesia and emergence from anesthesia begin

* 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 .

post operative emetic score

Time Frame: About 20 minutes after stopping anesthesia and emergence from anesthesia begin

* 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 .

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