Intraocular PressureNCT03933254
Intraocular Pressure and Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomies
An observational study of Intraocular Pressure and Intracranial Pressure, run by Marmara University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intraocular Pressure, Intracranial Pressure, Pneumoperitoneum
- What is being tested?
- Intraocular pressure measurement via ocular tonometry
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2019to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be ASA 1 or 2 physical status patients undergoing elective laparoscopic cholecystectomy.
Who may be able to join
- Patients undergoing laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) 1 or 2 physical status patients
- Elective surgeries
Who cannot join
- Patients with glaucoma
- ASA 3 or above patients
- Emergency surgeries
About this study
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.
- Being tested
- Intraocular pressure measurement via ocular tonometry
- Keywords
- Intraocular pressure, Optic nerve sheath diameter, Pneumoperitoneum, Laparoscopy, Laparoscopic surgery
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular pressure measurement via ocular tonometryDiagnostic test
Also called Optic nerve sheath diameter measurement via ultrasound
Intraocular pressure and optic nerve sheath diameter changes of the patients undergoing laparoscopic cholecystectomy will be measured throughout the surgery at different times using ocular tonometry and ultrasound, respectively.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
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.
Measured: Throughout the operation (usually about 1 hour).
Secondary outcomes (1)
Intracranial pressure
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.
Measured: Throughout the operation (usually about 1 hour).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study startMay 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: As a result of COVID-19 pandemics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruslan Abdullayev, Marmara University
- Investigators
- Ruslan Abdullayev, Principal investigator, Marmara University School of Medicine, Dep of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933254
- Sponsor's protocol ID
- 09.2019.264
- Status last verified
- Nov 2021
- First submitted
- 27 Apr 2019
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraocular Pressure and Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomies
- ClinicalTrials.gov ID
- NCT03933254
- Acronym / sponsor ID
- 09.2019.264
- Keywords
- Intraocular pressure, Optic nerve sheath diameter, Pneumoperitoneum, Laparoscopy, Laparoscopic surgery
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: As a result of COVID-19 pandemics
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be ASA 1 or 2 physical status patients undergoing elective laparoscopic cholecystectomy.
Key inclusion criteria (3 listed)
- Patients undergoing laparoscopic cholecystectomy
- American Society of Anesthesiologists (ASA) 1 or 2 physical status patients
- Elective surgeries
Key exclusion criteria (3 listed)
- Patients with glaucoma
- ASA 3 or above patients
- Emergency surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraocular pressure measurement via ocular tonometryAlso: Optic nerve sheath diameter measurement via ultrasoundIntraocular pressure and optic nerve sheath diameter changes of the patients undergoing laparoscopic cholecystectomy will be measured throughout the surgery at different times using ocular tonometry and ultrasound, respectively. | Diagnostic test | – |
Primary outcome
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.
1 secondary outcome
Intracranial pressure
Time frame: Throughout the operation (usually about 1 hour).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruslan Abdullayev principal investigator
Marmara University School of Medicine, Dep of Anesthesiology and Reanimation
Questions about this trial
What is this clinical trial studying?
An observational study of Intraocular Pressure and Intracranial Pressure, run by Marmara University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (time frame: Throughout the operation (usually about 1 hour).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.