Profopol and Remifentanil Sedation in Endoscopic Ultrasonography

April 28, 2024 updated by: Samsun University

Feasibility and Safety of Profopol and Remifentanil Sedation in Endoscopic Ultrasonography: A Prospective Observational Study

Endoscopic ultrasonography (EUS) is an endoscopic procedure performed to investigate conditions affecting the stomach, liver, and bile ducts, as well as for therapeutic interventions. The complexity of EUS can vary significantly, with increased complexity affecting procedure duration, technical success, and the occurrence of adverse events. For the comfort of patients and the success of the procedure, these interventions are typically performed under anesthesia with procedural sedation. To enhance the success rate of the procedure, reduce the risk of side effects, and maximize patient comfort, EUS is generally performed under sedation according to the recommendations of the American Society of Anesthesiologists (ASA). During sedation, the aim is for the patient to be more relaxed and comfortable while maintaining spontaneous respiratory function. Preserving spontaneous respiratory parameters is crucial for procedural safety.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this observational study is to investigate the safety and feasibility of sedation in patients undergoing endoscopic ultrasonography (EUS) in the endoscopy unit, where procedural sedation is administered for this purpose. Vital parameters will be recorded during the procedure and in the recovery unit. Data for the study will be obtained from nurse observation forms and anesthesia records found in patient files. It is an observational study of file scanning nature, which includes information contained in the files.

Within the scope of this study, patients undergoing endoscopic ultrasonography (EUS) under anesthesia in the endoscopy unit will be examined. Parameters such as hypotension, desaturation, and vital signs will be recorded during or after the routinely administered sedation procedure. The primary objective of the study is to evaluate the prevalence of major anesthesia-related complications such as arrhythmias, hypotension, and vomiting (safety endpoint). The secondary objectives are as follows: (a) to assess the prevalence of inadequate sedation symptoms such as movement, coughing, and hiccupping (feasibility endpoint); (b) to determine the time taken to achieve the target level of sedation.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Samsun, Turkey
        • Recruiting
        • Samsun University Faculty of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who will undergo endoscopic ultrasonography (EUS) under procedural sedation

Description

Inclusion Criteria:

  • Endoscopic ultrasonography (EUS) patients for procedural sedation

Exclusion Criteria:

  • Patients who do not sign the consent form.
  • Under the age of 18.
  • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anesthesia related major complications
Time Frame: 1 hour
arrhythmias, hypotension, desaturation and vomiting
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of symptoms of inadequate sedation
Time Frame: 1 hour
movement, cough and hiccups
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsun University

Investigators

  • Principal Investigator: Caner Genc, M.D., Samsun University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2024

Primary Completion (Estimated)

June 24, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2024

Last Update Submitted That Met QC Criteria

April 28, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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