CClinicalTrials.gg
Not yet recruitingNCT06215833Updated Jan 30, 2024

Recovery of TIVA vs Inhalation in Pediatric Anesthesia

An observational study in Best Technique for Pediatric Anesthesia, sponsored by Assiut University. Not yet recruiting. Open to participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2024-01-30.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
120
Ages
4 Years to 10 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Best Technique for Pediatric Anesthesia
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In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children planned for ambulatory tonsillectomy from primary care clinic

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Other
Time perspective
Prospective
Enrollment
120 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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

  • DrugPropofol

    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

  • DrugSevoflurane

    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

06

What researchers measure

Primary outcomes

  1. 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 .

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

  2. 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 .

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

  3. 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 .

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

  4. 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 .

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

  5. 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 .

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

  6. 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 .

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

  7. 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 .

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06215833
Lead sponsor
Assiut University
Responsible party
Ahmed Mahmoud Sayed (Principal Investigator, Assiut University) — Principal investigator
First posted
Jan 22, 2024
Start date
Jan 30, 2024 (estimated)
Primary completion
Dec 30, 2024 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Jan 30, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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