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NCT Number: NCT07190508

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Elazığ Fethi Sekin City Hospital

Elâzığ, Merkez, 23200, Turkey (Türkiye)

About this study

This single-center, prospective, observational cohort study is conducted at Elazig Fethi Sekin City Hospital, Türkiye. The study population consists of adults (≥18 years) scheduled for diagnostic upper gastrointestinal endoscopy under routine sedoanalgesia. Consecutive eligible patients are enrolled until the target sample size of 40 is reached. Exclusion criteria include any history of glaucoma, ocular surgery, or ongoing ophthalmological treatment.

All participants receive standard pre-sedation isotonic fluid replacement (500 mL) as per institutional protocol. Sedoanalgesia is administered with propofol, midazolam, and fentanyl at the discretion of the attending anesthesiologist, following routine practice. Intraocular pressure (IOP) is measured using a calibrated non-contact tonometer at four time points: (1) baseline before fluid loading, (2) after fluid replacement and before sedation, (3) after sedoanalgesia, and (4) immediately following duodenal intubation. Measurements are consistently taken from the same eye and patient position to ensure reliability.

In addition to IOP, systolic/diastolic blood pressure, mean arterial pressure, heart rate, and peripheral oxygen saturation are continuously monitored and recorded. Sedative drug doses and procedure times (total duration and time to duodenal passage) are documented. The primary outcome is the change in IOP between baseline and post-duodenal intubation. Secondary outcomes include correlations between hemodynamic variables, sedative consumption, and intraocular pressure changes, as well as subgroup analyses according to age, sex, and comorbidities.

Statistical analysis will include repeated-measures ANOVA or non-parametric equivalents to compare IOP at different time points, along with regression models to identify predictors of IOP changes. With a sample size of at least 34 patients (allowing for 40 to compensate for dropouts), the study has adequate power to detect clinically significant differences.

The results are expected to contribute to a better understanding of the physiological ocular effects of upper GI endoscopy and to inform clinical practice, especially in patients at risk of elevated intraocular pressure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

No Intervention (Observational)

Other

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

Primary outcomes

  1. Change in Intraocular Pressure (IOP)

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

    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.

Secondary outcomes

  1. Change in Systolic Blood Pressure (SBP)

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

    Systolic blood pressure will be recorded continuously at each predefined time point.

  2. Change in Diastolic Blood Pressure (DBP)

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

    Diastolic blood pressure will be recorded continuously at each predefined time point.

  3. Change in Mean Arterial Pressure (MAP)

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

    Mean arterial pressure will be recorded continuously at each predefined time point.

  4. Change in Heart Rate (HR)

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

    Heart rate will be recorded continuously at each predefined time point.

Sponsors and collaborators

Lead sponsor

Sevim Şenol Karataş

Other

Registry information

Official study title

The Effects of Pre-Sedation Fluid Replacement and Endoscopic Duodenal Passage on Intraocular Pressure: A Prospective Observational Study

Acronym: ENDO-IOP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 24, 2025
Registry last updated
Dec 3, 2025

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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