Comparison of Sedated and Unsedated PEG in Elderly ASA IV Patients

Sponsor
Mersin University
Study ID
NCT07758153
Status
Not Yet Recruiting

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Conditions

  • ASA Physical Status IV
  • Dysphagia
  • Elderly Patients (>65 Years)
  • Enteral Nutrition Feeding
  • Percutaneous Endoscopic Gastrostomy

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Study Details

This prospective observational cohort study aims to compare the safety and clinical outcomes of sedated and unsedated percutaneous endoscopic gastrostomy procedures in elderly patients classified as ASA IV. The primary outcome is the development of cardiopulmonary complications within the first 24 hours after the procedure. Secondary outcomes include technical success, procedure duration, early procedure-related complications, length of hospital stay, intensive care requirement, 30-day mortality, and 30-day readmission.

Key Dates

First listed
Aug 11, 2026
Start date
Jul 15, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
70 participants (estimated)

Arms

  • Arm: Unsedated PEG
    Elderly ASA IV patients undergoing percutaneous endoscopic gastrostomy with topical pharyngeal anesthesia and local anesthesia, without systemic sedative medication.
  • Arm: Sedated PEG
    Elderly ASA IV patients undergoing percutaneous endoscopic gastrostomy under sedation as part of routine clinical practice. Sedative agents may include propofol, midazolam, and/or opioid agents according to clinical and anesthesiology evaluation.

Primary Outcome Measure

Incidence of cardiopulmonary complications within 24 hours after PEG placement [ Time Frame: Within 24 hours after PEG placement ]

Central Contacts

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