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Completed

NCT Number: NCT06389045

Propofol Infusion-Based Sedation on Anesthesia-Related Adverse Events in Endoscopic Ultrasonography

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.

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Key information

Conditions

Sedation Complication Endoscopic Ultrasonography Procedural Sedation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsun University Faculty of Medicine

Samsun, Turkey (Türkiye)

About this study

Within the scope of this study, patients undergoing endoscopic ultrasonography (EUS) under anesthesia in the endoscopy unit will be examined. We administered propofol infusion for procedural sedation for patients undergoing therapeutic EUS in our hospital's endoscopy unit. We aimed to evaluate the impact of this sedation method on anesthesia-related adverse events. The primary outcome of this study was to evaluate the anesthesia-related adverse events, which were defined as arrhythmia, hypotension, desaturation, vomiting, undesirable patient movement, coughing, and hiccups during EUS probe insertion. The secondary outcome was defined as the patient's recovery time from anesthesia. In addition, bolus/infusion drug doses used for anesthesia induction and maintenance, demographic data, EUS indications in patients, and comorbidities of patients were recorded.

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Procedural Sedation

Other

Profopol Sedation in Endoscopic Ultrasonography

Primary outcomes

  1. Anesthesia related advers events

    Time frame: during the procedure

    arrhythmia, hypotension, desaturation, vomiting, patient movement, cough during EUS probe insertion, hiccups

Secondary outcomes

  1. recovery time

    Time frame: 1 hour

    Each patient was evaluated using the Post-Anesthetic Discharge Score (PADS)

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

Effect of Propofol Infusion-Based Sedation on Anesthesia-Related Adverse Events in Endoscopic Ultrasonography: A Prospective Observational Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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