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Completed

NCT Number: NCT07190508

Intraocular Pressure Changes During EGD

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.

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Key information

Age range

18 year and older

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 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.

Who can participate

Healthy volunteers accepted: No

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

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

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 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 outcomes

  1. Change in Systolic Blood Pressure (SBP)

    Time frame: 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.

  2. Change in Diastolic Blood Pressure (DBP)

    Time frame: 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.

  3. Change in Heart Rate (HR)

    Time frame: 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.

  4. Difference in Intraocular Pressure Between the Dependent and Non-Dependent Eyes

    Time frame: During 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.

Sponsors and collaborators

Lead sponsor

Sevim Şenol Karataş

Other

Registry information

Official study title

Sedation-related Intraocular Pressure Changes During Esophagogastroduodenoscopy: 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
Sep 9, 2026

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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