Health TrialsbyHealthPanel

Effects of Remimazolam and Ciprofol TIVA on PRAE in Pediatric Tonsillectomy and Adenoidectomy

ConditionTonsillectomy With or Without Adenoidectomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-12
SponsorTongji Hospital

About this trial

To observe the effects of remimazolam versus ciprofol TIVA on PRAE in pediatric tonsillectomy and adenoidectomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 2-12 years

ASA physical status I-II

Body mass index (BMI): 14-28 kg/m²

Scheduled for elective tonsillectomy with or without adenoidectomy

Disqualifiers

History of severe pulmonary diseases (e.g., asthma, bronchiectasis, severe OSA)

Previous episodes of significant PRAEs

Documented drug allergies (e.g., to remimazolam, propofol, or ciprofol)

Comorbidities including: Uncorrected congenital heart disease, neuromuscular disorders, Developmental delay, Abnormal hepatic/renal function

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remimazolam

    Drug

    remimazolam induction (0.3-0.5 mg/kg) + maintenance (1-3 mg/kg/h)

  • Propofol

    Drug

    Anesthesia induction (2-3 mg/kg) + Anesthesia maintenance (6-10 mg/kg/h)

  • Ciprofol

    Drug

    Anesthesia induction (0.4-0.5 mg/kg) + Anesthesia maintenance (0.8-1.2 mg/kg/h)

Treatment groups

114 Participants
are divided into 3 treatment groups
Group A: Propofol groupActive comparator 1 intervention
Group B: Remimazolam groupExperimental treatment 1 intervention
Group C: Ciprofol groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of perioperative respiratory adverse events

The perioperative respiratory adverse events including: laryngospasm, bronchospasm, severe cough, oxygen desaturation, airway obstruction.

Time frame
5days

Secondary outcomes

1

Anesthesia duration

From anesthesia induction to discontinuation of anesthetics

Time frame
1 day
2

Emergence time

From anesthetic discontinuation to eye opening on command

Time frame
1 day
3

Extubation time

From anesthetic discontinuation to endotracheal tube removal

Time frame
1 day
4

PACU stay duration

From PACU admission to meeting discharge criteria

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tongji Hospital

Lead sponsor

Source ClinicalTrials.gov
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