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Intraocular Pressure and Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomies

  • Clinicaltrials.gov identifier

    NCT03933254

  • Recruitment Status

    Not yet recruiting

  • First Posted

    May 1, 2019

  • Last update posted

    May 1, 2019

Study Description

Brief summary:

Pneumoperitoneum created during laparoscopic surgeries has some effects on human physiology. Increased intraabdominal pressure results in increased intrathoracic pressure, and eventually may result in increased intracranial and intraocular pressures. In this study we aimed to identify intraocular and intracranial pressure changes during the perioperative period due to the pneumoperitoneum created for laparoscopic cholecystectomy surgeries. Intraocular pressure will be measured directly from the eye. Intracranial pressure will be estimated by measuring optic nerve sheath diameter changes ultrasonographically.

  • Condition or Disease:Intraocular Pressure
    Intracranial Pressure
    Pneumoperitoneum
  • Intervention/Treatment: Diagnostic Test: Intraocular pressure measurement via ocular tonometry
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Observational
  • Estimated Enrollment: 30 participants
  • Observational Model: Other
  • Time Perspective: Prospective
  • Official Title: Intraocular Pressure and Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomies
  • Estimated Study Start Date: May 2019
  • Estimated Primary Completion Date: December 2019
  • Estimated Study Completion Date: January 2020

Outcome Measures

  • Primary Outcome Measures: 1. Intraocular pressure [ Time Frame: Throughout the operation (usually about 1 hour). ]
    The normal physiological value for intraocular pressure is 10-20 mm Hg. It is affected by pneumoperitoneum created for laparoscopy. The pressure will be measured via ocular tonometry through the eye during the surgery at predetermined time intervals.
  • Secondary Outcome Measures: 1. Intracranial pressure [ Time Frame: Throughout the operation (usually about 1 hour). ]
    The normal physiological value for intracranial pressure is below 10 mm Hg. It is affected by pneumoperitoneum created for laparoscopy. The pressure will be estimated through changes in the optic nerve sheath diameter which will be measured by ultrasonography through the eye during the surgery at predetermined time intervals.

Eligibility Criteria

  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: The study population will be ASA 1 or 2 physical status patients undergoing elective laparoscopic cholecystectomy.

Criteria

Inclusion Criteria:

- Patients undergoing laparoscopic cholecystectomy

- American Society of Anesthesiologists (ASA) 1 or 2 physical status patients

- Elective surgeries

Exclusion Criteria:

- Patients with glaucoma

- ASA 3 or above patients

- Emergency surgeries

Contacts and Locations

Contacts

Contact: Ruslan Abdullayev +905063010833 ruslan_jnr@hotmail.com

Locations

Sponsors and Collaborators

Marmara University

Investigators

Principal Investigator: Ruslan Abdullayev Marmara University School of Medicine, Dep of Anesthesiology and Reanimation

More Information

  • Responsible Party: Marmara University
  • ClinicalTrials.gov Identifier: NCT03933254 History of Changes
  • Other Study ID Numbers: Lap chol - IOP, ONSD
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: May 1, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Marmara University: Intraocular pressure
    Optic nerve sheath diameter
    Pneumoperitoneum
    Laparoscopy
    Laparoscopic surgery
  • Additional relevant MeSH terms: Pneumoperitoneum