Recovery of TIVA vs Inhalation in Pediatric Anesthesia

January 27, 2024 updated by: Ahmed Mahmoud Sayed, Assiut University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 .
About 20 minutes after stopping anesthesia and emergence from anesthesia begin
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 .
About 20 minutes after stopping anesthesia and emergence from anesthesia begin
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 .
About 20 minutes after stopping anesthesia and emergence from anesthesia begin
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 .
About 20 minutes after stopping anesthesia and emergence from anesthesia begin
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 .
About 20 minutes after stopping anesthesia and emergence from anesthesia begin
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 .
About 20 minutes after stopping anesthesia and emergence from anesthesia begin
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 .
About 20 minutes after stopping anesthesia and emergence from anesthesia begin

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Best Technique for Pediatric Anesthesia

Clinical Trials on Propofol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings