Pre-Sedation Fluid Replacement and Duodenal Passage Effects on Intraocular Pressure

NCT07190508 | Completed

• 1 other identifier: EFSH-ANES-2025-09-IOP
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational study investigates whether routine pre-sedation isotonic fluid replacement and the passage of the endoscope into the duodenum acutely affect intraocular pressure (IOP) in adult patients undergoing diagnostic upper gastrointestinal endoscopy. A non-contact tonometer is used to measure IOP at four predefined time points: baseline, after pre-sedation fluid replacement, after sedoanalgesia, and immediately following duodenal intubation. Hemodynamic parameters, oxygen saturation, and sedative doses are also recorded. The primary aim is to determine changes in IOP during the procedure, while secondary outcomes include the relationship between hemodynamic fluctuations, sedative requirements, and IOP changes. The findings are expected to provide insights into the safety of endoscopy with respect to ocular physiology, particularly in patients at risk of increased intraocular pressure.

Conditions

Intraocular Pressure Changes; Upper Gastrointestinal Endoscopy

Keywords

Intraocular Pressure; Endoscopy, Gastrointestinal; Sedation; Propofol; Midazolam; Fentanyl; Duodenum; Tonometer

Outcome Measures

Primary Outcomes (1)

• Change in Intraocular Pressure (IOP)

  IOP is measured using a calibrated non-contact tonometer at four predefined time points: baseline, after isotonic fluid replacement, after sedoanalgesia, and after endoscopic duodenal passage. Measurements are obtained from the same eye in the same patient position to ensure consistency.

  During the procedure (baseline, after fluid replacement, after sedoanalgesia, and immediately after duodenal intubation; total duration ≈ 30 minutes)

Secondary Outcomes (4)

• Change in Systolic Blood Pressure (SBP)

  During the procedure (baseline, after fluid replacement, after sedoanalgesia, and after duodenal intubation; ~30 minutes)

• Change in Diastolic Blood Pressure (DBP)

  During the procedure (baseline, after fluid replacement, after sedoanalgesia, and after duodenal intubation; ~30 minutes)

• Change in Mean Arterial Pressure (MAP)

  During the procedure (baseline, after fluid replacement, after sedoanalgesia, and after duodenal intubation; ~30 minutes)

• Change in Heart Rate (HR)

  During the procedure (baseline, after fluid replacement, after sedoanalgesia, and after duodenal intubation; ~30 minutes)

Study Arms (1)

Upper GI Endoscopy Patients

Adult patients (≥18 years) undergoing diagnostic upper gastrointestinal endoscopy with standard pre-sedation isotonic fluid replacement and sedoanalgesia. Intraocular pressure is measured at four predefined time points: baseline, after fluid replacement, after sedoanalgesia, and after duodenal intubation.

Other: No Intervention (Observational)

Interventions

No Intervention (Observational) OTHER

Participants undergo routine diagnostic upper gastrointestinal endoscopy with standard institutional care. No additional intervention is applied beyond usual clinical practice.

Upper GI Endoscopy Patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) scheduled for diagnostic upper gastrointestinal endoscopy under sedoanalgesia at Elazig Fethi Sekin City Hospital. Consecutive eligible patients will be approached and enrolled after providing informed consent.

You may qualify if:

• Adults ≥18 years
• Scheduled for diagnostic upper gastrointestinal endoscopy under sedoanalgesia
• ASA physical status I-III
• Voluntarily provides informed consent

You may not qualify if:

• History of glaucoma or ocular hypertension
• Previous ocular surgery or ongoing ophthalmological treatment
• Known contraindications to sedoanalgesia (propofol, midazolam, fentanyl)
• ASA physical status IV or higher

Sponsors & Collaborators

• Sevim Şenol Karataş: lead

Study Sites (1)

Elazığ Fethi Sekin City Hospital

Elâzığ, Merkez, 23200, Turkey (Türkiye)

Location

Related Publications (2)

• Berdahl JP, Allingham RR, Johnson DH. Cerebrospinal fluid pressure is decreased in primary open-angle glaucoma. Ophthalmology. 2008 May;115(5):763-8. doi: 10.1016/j.ophtha.2008.01.013.

  PMID: 18452762 BACKGROUND

• Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anesthesiologist administration of propofol for GI endoscopy. Endoscopy. 2010 Nov;42(11):960-74. doi: 10.1055/s-0030-1255728. Epub 2010 Nov 11.

  PMID: 21072716 BACKGROUND

Related Links

• Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation

Study Officials

• Sevim Şenol Karataş, MD

  Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist in Anesthesiology

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 24, 2025
• Study Start: September 16, 2025
• Primary Completion: October 16, 2025
• Study Completion: October 16, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)