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

NCT ID: NCT07190508

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-16
• Study Completion Date: 2025-10-16

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.

Detailed Description

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.

Conditions

Intraocular Pressure Changes; Upper Gastrointestinal Endoscopy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No Intervention (Observational)

Intervention Type: OTHER

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

Interventions

No Intervention (Observational)

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sevim Şenol Karataş

OTHER

Sponsor Role: lead

Responsible Party

Sevim Şenol Karataş

Specialist in Anesthesiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sevim Şenol Karataş, MD

Role: PRINCIPAL_INVESTIGATOR

Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation

Locations

Elazığ Fethi Sekin City Hospital

Elâzığ, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 18452762 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21072716 (View on PubMed)

Related Links

https://elazigsehir.saglik.gov.tr/

Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation

Other Identifiers

EFSH-ANES-2025-09-IOP

Identifier Type: -

Identifier Source: org_study_id