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Intraocular Pressure Changes During EGD

Sedation-related Intraocular Pressure Changes During Esophagogastroduodenoscopy: a Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07190508
Acronym
ENDO-IOP
Enrollment
53
Registered
2025-09-24
Start date
2025-07-01
Completion date
2025-11-01
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraocular Pressure Changes, Upper Gastrointestinal Endoscopy

Keywords

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

Brief summary

This prospective observational study evaluates short-term changes in intraocular pressure (IOP) during elective esophagogastroduodenoscopy (EGD) performed under routine sedation. IOP is measured bilaterally using a handheld rebound tonometer (Icare IC200) at four predefined procedural time points: baseline in the sitting position (T0), after routine administration of 500 mL isotonic intravenous fluid in the sitting position (T1), after sedation in the left lateral decubitus position before endoscopy (T2), and when the endoscope reaches the second portion of the duodenum (T3). The primary outcome is the within-subject change in IOP across these procedural stages. Secondary analyses include differences between the dependent and non-dependent eyes in the left lateral decubitus position and exploratory assessment of factors associated with the change in left-eye IOP from baseline to duodenal passage. No study-specific intervention or treatment allocation is performed; all clinical procedures follow routine institutional practice.

Detailed description

This single-center, prospective observational cohort study was conducted at Elazig Fethi Sekin City Hospital, Türkiye, in adults (≥18 years) undergoing elective esophagogastroduodenoscopy (EGD) under routine sedation. Consecutive patients were screened for eligibility. Exclusion criteria included glaucoma or ocular hypertension, corneal disease affecting intraocular pressure (IOP) or corneal thickness measurements, ocular infection, severe dry eye disease, hemodynamic instability, heart failure, renal failure, cirrhosis or other conditions contraindicating fluid loading, use of topical ocular medications, and previous ocular surgery or refractive laser procedures. After venous access was established, baseline central corneal thickness and bilateral IOP were measured. As part of routine institutional practice, patients received 500 mL of 0.9% NaCl intravenously over approximately 10-15 minutes before sedation. This fluid administration was not assigned as a study-specific experimental intervention. Sedation was administered as part of routine clinical care using midazolam 0.02 mg/kg IV and propofol 0.5 mg/kg IV, with additional 10-20 mg propofol boluses as clinically required. Spontaneous breathing was maintained, supplemental oxygen was administered by nasal cannula, and noninvasive blood pressure, cardiac rhythm, and peripheral oxygen saturation were continuously monitored. Intraocular pressure was measured bilaterally using a handheld rebound tonometer (Icare IC200) at four predefined procedural time points: T0, baseline before fluid administration and sedation in the sitting position; T1, after administration of 500 mL isotonic fluid in the sitting position; T2, after sedation in the left lateral decubitus position and before endoscopy; and T3, when the endoscope reached the second portion of the duodenum while the patient remained in the left lateral decubitus position. The primary outcome was the within-subject change in IOP across T0-T3. Secondary analyses included paired comparison of the dependent and non-dependent eyes at T2 and T3 and exploratory multivariable analysis of factors associated with the change in left-eye IOP from baseline to duodenal passage (T3-T0). Repeated-measures analyses were used to evaluate changes over time. No study-specific intervention or treatment allocation was performed; all clinical procedures were conducted according to routine institutional practice. Forty-seven participants with complete IOP measurements at all predefined time points were included in the final analysis.

Interventions

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

Sponsors

Sevim Şenol Karataş
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥18 years * Scheduled for elective esophagogastroduodenoscopy (EGD) * Acceptance of the procedure under sedation * Ability to cooperate with intraocular pressure (IOP) and central corneal thickness (CCT) measurements

Exclusion criteria

* Diagnosis of glaucoma or ocular hypertension * Corneal diseases that could affect intraocular pressure or central corneal thickness measurements * Ocular infection * Severe dry eye disease * Hemodynamic instability * Heart failure * Renal failure * Cirrhosis or other clinical conditions contraindicating fluid loading * Use of topical ocular medications, including antiglaucoma drugs or topical steroids * History of ocular surgery * History of refractive laser procedures

Design outcomes

Primary

MeasureTime frameDescription
Change in Intraocular Pressure (IOP)During the EGD procedure, from baseline before fluid administration to advancement of the endoscope into the second portion of the duodenum.Intraocular pressure (IOP) is measured bilaterally using a handheld rebound tonometer (Icare IC200) at four predefined procedural time points: T0, baseline before fluid administration and sedation in the sitting position; T1, after administration of 500 mL isotonic intravenous fluid in the sitting position; T2, after sedation in the left lateral decubitus position and before the start of endoscopy; and T3, when the endoscope reaches the second portion of the duodenum while the patient remains in the left lateral decubitus position. The primary outcome is the within-subject change in IOP across T0-T3.

Secondary

MeasureTime frameDescription
Change in Systolic Blood Pressure (SBP)During the EGD procedure, from baseline before fluid administration (T0) to advancement of the endoscope into the second portion of the duodenum (T3).Systolic blood pressure is monitored throughout the procedure and recorded at the four predefined study time points (T0-T3) to evaluate within-subject changes across procedural stages.
Change in Diastolic Blood Pressure (DBP)During the EGD procedure, from baseline before fluid administration (T0) to advancement of the endoscope into the second portion of the duodenum (T3).Diastolic blood pressure is monitored throughout the procedure and recorded at the four predefined study time points (T0-T3) to evaluate within-subject changes across procedural stages.
Change in Heart Rate (HR)During the EGD procedure, from baseline before fluid administration (T0) to advancement of the endoscope into the second portion of the duodenum (T3).Heart rate is monitored throughout the procedure and recorded at the four predefined study time points (T0-T3) to evaluate within-subject changes across procedural stages.
Difference in Intraocular Pressure Between the Dependent and Non-Dependent EyesDuring the EGD procedure at T2 and T3.Intraocular pressure is compared between the dependent left eye and the non-dependent right eye while patients are in the left lateral decubitus position. Paired inter-eye differences are evaluated at T2, after sedation and before the start of endoscopy, and at T3, when the endoscope reaches the second portion of the duodenum.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORSevim Şenol Karataş, MD

Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026