Intraocular Pressure Changes During EGD

NCT07190508 | Completed

• 1 other identifier: EFSH-ANES-2025-09-IOP
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

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)

  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.

  During the EGD procedure, from baseline before fluid administration to advancement of the endoscope into the second portion of the duodenum.

Secondary Outcomes (4)

• 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).

• 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).

• 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).

• Difference in Intraocular Pressure Between the Dependent and Non-Dependent Eyes

  During the EGD procedure at T2 and T3.

Study Arms (1)

Upper GI Endoscopy Patients

Adult patients (≥18 years) undergoing elective esophagogastroduodenoscopy (EGD) under routine sedation. As part of routine institutional practice, patients receive 500 mL of 0.9% NaCl intravenously before sedation. Intraocular pressure is measured bilaterally at four predefined procedural time points: baseline in the sitting position (T0), after fluid administration 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).

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

Study Population

Consecutive adult patients scheduled for elective esophagogastroduodenoscopy (EGD) under routine sedation at the endoscopy unit of Elazig Fethi Sekin City Hospital were screened for eligibility. Patients meeting the predefined inclusion criteria and without any exclusion criteria were enrolled in this prospective observational cohort.

You may qualify if:

• 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

You may not qualify if:

• 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

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: July 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)