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Study on Sedation Safety and Effectiveness in Bronchoscopy: Comparing Propofol/Pethidine and Midazolam/Pethidine for Patients with Respiratory Conditions

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients undergoing a procedure called bronchoscopy, which is used to diagnose and manage various lung diseases. During this procedure, a flexible tube is inserted into the airways to allow doctors to see inside the lungs. To make the procedure more comfortable, a combination of medications is used to help patients relax and reduce pain, a process known as analgosedation.

The study aims to compare the safety and effectiveness of two different medication combinations used during bronchoscopy. The first combination includes Propofol and Pethidine, while the second combination includes Midazolam and Pethidine. Propofol and Midazolam are medications that help with sedation, making patients feel sleepy and relaxed, while Pethidine is a pain reliever. The study will be conducted by medical staff at San Donato Hospital in Arezzo.

Participants in the study will receive one of the two medication combinations during their bronchoscopy. The main goal is to assess how well each combination works in terms of safety and effectiveness, particularly looking at how often patients experience low oxygen levels during the procedure. Other factors, such as any side effects, how well patients tolerate the procedure, and the time it takes to complete, will also be evaluated. The study will help determine which combination of medications provides the best balance of comfort and safety for patients undergoing bronchoscopy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. Participants must be over 18 years old and able to provide informed consent. The study is for those scheduled for a bronchoscopy, which is a procedure to look inside the lungs.

  2. Step 2

    Preparation for bronchoscopy

    Before the procedure, participants are informed about the two sedation regimens being compared: propofol with pethidine and midazolam with pethidine. These medications help in sedation and pain relief during the procedure.

  3. Step 3

    Administration of medication

    Participants receive one of the two medication combinations through an infusion. The medical team administers the drugs to ensure comfort and safety during the bronchoscopy.

  4. Step 4

    Bronchoscopy procedure

    During the bronchoscopy, the medical team monitors the participant's oxygen levels and overall condition. The primary goal is to assess the safety and effectiveness of the sedation regimen.

  5. Step 5

    Post-procedure monitoring

    After the procedure, participants are observed for any adverse events or complications. The medical team evaluates recovery using scores like the Aldrete score, which measures how well participants recover from sedation.

  6. Step 6

    Follow-up and evaluation

    Participants may be asked to attend follow-up appointments to assess any delayed effects of the medications and to ensure overall well-being. The study aims to compare the desaturation index, which measures oxygen levels, and other outcomes between the two drug regimens.

Who can join the trial?

6 criteria

  • Patients must be **18 years or older**.
  • Patients can be of **any gender**.
  • Patients must be able to **understand** and **provide consent** to participate in the study.
  • Patients must be scheduled for a **bronchoscopy**. This is a procedure where a doctor looks inside the lungs using a thin tube with a camera.
  • The bronchoscopy can be for **diagnostic** purposes (to find out what is wrong) or **therapeutic** purposes (to treat a condition).
  • The procedure may include **echoendoscopy**, which is a special type of imaging used during the bronchoscopy.

Who cannot join the trial?

10 criteria

  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care.
  • Patients who have any medical condition that could make the procedure unsafe for them.
  • Patients who are unable to give informed consent, which means they cannot fully understand the study and agree to participate.
  • Patients who are pregnant or breastfeeding, as the study might affect them or their baby.
  • Patients who have allergies or adverse reactions to the medications used in the study.
  • Patients who are currently participating in another clinical trial, as this could interfere with the study results.
  • Patients with a history of substance abuse, which could affect their response to the medications.
  • Patients with severe heart, liver, or kidney problems, as these conditions could increase the risk of complications.
  • Patients with a history of severe respiratory issues that could worsen with the procedure.
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Investigated drugs

  • Propofol

    is a medication used to help relax patients and make them sleepy during medical procedures. It is often used for sedation because it works quickly and allows for a smooth recovery.

  • Pethidine

    , also known as meperidine, is a pain-relieving medication. It is used to help manage pain and discomfort during medical procedures, making the experience more comfortable for the patient.

  • Midazolam

    is a medication that helps to relax patients and reduce anxiety. It is commonly used for sedation during medical procedures, helping patients feel calm and at ease.

What is already known about the treatment

  • Propofol

    Propofol is administered intravenously and is used to induce and maintain sedation during medical procedures. It is widely recognized in medical literature as a safe and effective sedative agent. The main therapeutic indication for Propofol in this trial is to facilitate sedation during bronchoscopic procedures. At the molecular level, Propofol works by enhancing the activity of the neurotransmitter GABA, leading to a calming effect on the brain. It is classified as a general anesthetic.

  • Pethidine

    Pethidine, also known as Meperidine, is administered intravenously and is used for pain relief during medical procedures. It is well-documented in medical literature as an effective analgesic. In this trial, Pethidine is used to manage pain during bronchoscopic procedures. It works by binding to opioid receptors in the brain, altering the perception of pain. Pethidine is classified as an opioid analgesic.

  • Midazolam

    Midazolam is administered intravenously and is used to induce sedation and reduce anxiety during medical procedures. It is a well-established sedative in medical literature. The main therapeutic indication for Midazolam in this trial is to provide sedation during bronchoscopic procedures. It acts by enhancing the effect of the neurotransmitter GABA, resulting in a calming effect on the central nervous system. Midazolam is classified as a benzodiazepine.

Investigated diseases

Respiratory Diseases – These are conditions that affect the lungs and other parts of the respiratory system. They can range from mild, like the common cold, to severe, such as chronic obstructive pulmonary disease (COPD) or lung cancer. Symptoms often include coughing, wheezing, shortness of breath, and chest discomfort. The progression of these diseases can vary widely; some may resolve on their own, while others may lead to long-term health issues. Environmental factors, infections, and genetics can all play a role in their development. Regular monitoring and lifestyle changes can help manage symptoms and improve quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518820-65-00Protocol codeABroProMidaEstimated enrolment530 patientsSponsorAzienda Unita' Sanitaria Locale Toscana Sud Est

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