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Not yet recruitingNCT07934342Updated Nov 12, 2026

Postoperative Behavioral Disorder in Children After Tensillectomy

An interventional study of TIVA versus Inhalation in Behavioral Disorder, sponsored by University Tunis El Manar. Not yet recruiting at 1 site in Tunisia. Open to participants aged 2 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by University Tunis El Manar · Not applicable, Interventional, and Basic science

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
2 Years to 12 Years
Sex
All
01

Study summary

Patients were randomly allocated into two groups according to the anesthetic technique : Total intravenous anesthesia (TIVA) or inhalational anesthesia

02

Conditions studied

  • Behavioral Disorder

Browse trials for

03

In context

Mental Disorders

1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.

This study's planned enrollment of 90 is close to the median of 100 across 1,301 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

University Tunis El Manar is the lead sponsor of 75 studies on the registry; 13 are open to participants now.

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

04

Who can participate

Ages eligible
2 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 2 and 12 years
  • Patients with an physical status I to II
  • Signed parental
  • Patients scheduled for tensillectomy with or withoud adenoidectomy

Exclusion criteria

Exclusion Criteria:

  • Histoy of previous general anesthesia, to avoid potential recall bias or pre-existing anxiety
  • Neurological or psychological disorders
  • to either the proposed anesthetic agents
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    TIVA

    Propofol-based intravenous anesthesia

    Procedure: TIVA versus Inhalation

  • Active comparator
    Inhalational anesthesia

    Sevoflurane-based inhalational anesthesia

    Procedure: TIVA versus Inhalation

Interventions

  • ProcedureTIVA versus Inhalation

    Compare the effects of sevoflurane based inhalational anesthesia versus propofol based intravenous anesthesia on the occurence of postoperative behavioral changes in children undergoing tensillectomy, using the PHBQ-AS score

06

What researchers measure

Primary outcomes

  1. Behavioral changes scores at 7 days postoperatively

    Time frame: 1 day, 7 days and 30 days postoperatively

Secondary outcomes

  1. Postoperative sleep quality

    Assessment of postoperative sleep quality using the Athens Insomnia Scale (AIS)

    Time frame: 24 hours after surgery

  2. Postoperative emergence agitation

    Assessment of postoperative emergence agitation using the Pediatric Anesthesia Emergence Delirium (PAED) scale

    Time frame: 1 hour after surgery

  3. Postoperative pain

    Comparaison of the analgesic efficacy of the two anesthetic techniques using the Face, Legs, Activity, Cry and Consolability (FLACC) scale

    Time frame: 1 hour after surgery

07

Study locations

1 site
  • Nabeul hospital, Mohamed Taher Maamouri, Nabeul, Mrezga 8000
    Nabeul, Tunisia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Nov 2027, 11 months later.

Of 666 non-industry interventional studies with no phase under Mental Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 45. This study's planned 11 months is below that.

Counting every sponsor, half of 680 studies reached it within 29 months; a quarter within 13 and three quarters within 45.

Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2026
First posted
Nov 12, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Nov 30, 2027
CompletionEst.
Dec 31, 2027
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07934342
Lead sponsor
University Tunis El Manar
Responsible party
Chaima Debabi (Principal Investigator, University Tunis El Manar) — Principal investigator
First posted
Nov 12, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Nov 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 12, 2026

Study contacts

Chaima Debabi
Contact
chaima.debabi@fmt.utm.tn
+21653824578

Oversight

Data monitoring committee
No
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 Nov 2026. You cannot join it, but the record below documents what was studied.

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