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Balanced Analgosedation in Bronchoscopy: Propofol/Pethidine Versus Midazolam/Pethidine

NCT06736938 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 530

Last updated 2024-12-17

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the safety and efficacy of two pharmacological sedation regimens during bronchoscopy procedures in adult patients who require elective bronchoscopy.

The main questions it aims to answer are:

* Is propofol/pethidine analgesia administered by a pulmonologist as effective and safe as midazolam/pethidine in achieving adequate sedation during bronchoscopy, particularly in terms of desaturation rate?
* Does the choice of sedative (midazolam vs. propofol) influence the occurrence of adverse events or need for escalated care?

Conditions

  • Sedation During Bronchoscopy

Interventions

DRUG

Propofol 1%

Propofol 1% is infused intravenously, initially at a bolus dose of 0.5 mg/kg followed by a maintenance dose in a continuous infusion of 0.5-1.0 mg/kg/hour.

DRUG

Midazolam

Midazolam is administered intravenously at an initial dose of 2 mg, as a bolus, followed by aliquots of 0.5 mg or 1 mg.

DRUG

Pethidine

Pethidine (100 mg/2 ml) is administered intravenously at a dosage of 0.5 mg/kg.

Sponsors & Collaborators

  • Azienda USL Toscana Sud Est

    collaborator OTHER_GOV

  • Ospedale San Donato, Arezzo

    collaborator UNKNOWN

  • Fondazione Andrea Cesalpino Arezzo ONLUS

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2027-04-01
Completion
2027-04-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06736938 on ClinicalTrials.gov