Best Technique for Pediatric AnesthesiaNCT06215833
Recovery of TIVA vs Inhalation in Pediatric Anesthesia
An observational study of Best Technique for Pediatric Anesthesia, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Best Technique for Pediatric Anesthesia
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2024to 30 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children planned for ambulatory tonsillectomy from primary care clinic
Who may be able to join
- child between 4 to 10 years
- without co morbidity
- ASA score 1
- mallampati score 1 and 2
Who cannot join
- child below 4 years and above 10 years
- child with co morbidity
- ASA score above 1
- mallampati score 3 and 4
About this study
Official title: 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.
Read the 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.
- Conditions
- Best Technique for Pediatric Anesthesia
- Being tested
- Propofol, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Cetal suppository
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
SevofluraneDrug
Also called Cetal suppository
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
| Study group | Role | What they receive |
|---|---|---|
| Group ( p ) | This group will undergo anesthesia via total intravenous anesthesia using Propofol in induction and maintenance Receives: Drug: Propofol | |
| Group ( s ) | This group undergo anesthesia via total inhalational anesthesia using sevoflurane in induction and maintenance Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: About 20 minutes after stopping anesthesia and emergence from anesthesia begin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start30 Jan 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Best Technique for Pediatric AnesthesiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215833
- Sponsor's protocol ID
- TIVA vs inhalation anesthesia
- Status last verified
- Jan 2024
- First submitted
- 10 Dec 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Emergence and Recovery Profile After Total Intravenous Anesthesia ( TIVA ) Vs Inhalational Anesthesia in Opioid Free Pediatric Tonsillectomy
- ClinicalTrials.gov ID
- NCT06215833
- Acronym / sponsor ID
- TIVA vs inhalation anesthesia
- Conditions
- Best Technique for Pediatric Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group ( p ) | – | Drug: PropofolThis group will undergo anesthesia via total intravenous anesthesia using Propofol in induction and maintenance |
| Group ( s ) | – | Drug: SevofluraneThis group undergo anesthesia via total inhalational anesthesia using sevoflurane in induction and maintenance |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children planned for ambulatory tonsillectomy from primary care clinic
Key inclusion criteria (4 listed)
- child between 4 to 10 years
- without co morbidity
- ASA score 1
- mallampati score 1 and 2
Key exclusion criteria (4 listed)
- child below 4 years and above 10 years
- child with co morbidity
- ASA score above 1
- mallampati score 3 and 4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: Cetal suppositoryAll 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 | Drug | Group ( p ) |
| SevofluraneAlso: Cetal suppositoryAll 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 | Drug | Group ( s ) |
Primary outcome
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 .
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 .
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 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 .
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 .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Best Technique for Pediatric Anesthesia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of consciousness score (time frame: About 20 minutes after stopping anesthesia and emergence from anesthesia begin). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.