ONSD in Laparoscopic SurgeryNCT06650475
"Optic Nerve Sheath Diameter; Low vs. Conventional Insufflation Pressures''
A study testing Using low or standart pressure in people with ONSD in Laparoscopic Surgery, run by Konya City Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Objective: This study investigates the impact of carbon dioxide (CO2) pneumoperitoneum on optic nerve sheath diameter (ONSD) and intracranial pressure (ICP) in patients undergoing total laparoscopic hysterectomy. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- ONSD in Laparoscopic Surgery
- What is being tested?
- Using low or standart pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 21 Oct 2024to 10 Jan 2025
- Phase
- Interventional
- 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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The study will be conducted in patients under 18 years of age with American Society of Anesthesiologists (ASA) I-II.
Who cannot join
- Patients with a history of neurological disease, glaucoma, surgery exceeding 2 hours, known chronic obstructive pulmonary disease (COPD), heart disease, and previous lung surgery will be excluded from the study. Patients with intraoperative hemodynamic problems; ETCO2 greater than 45 mmHg, plateau pressure over 30 cmH2, and peak inspiratory pressure over 35 cmH2 will be excluded from the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Konya City Hospital
Konya, Meram, 42140
Yasin Tire
Konya, Meram, 42140
About this study
Official title: Evaluation of the Optic Nerve Sheath Diameter in Children Undergoing Laparoscopic Abdominal Surgery at Low and Standard Gas Insufflation Pressures
Objective: This study investigates the impact of carbon dioxide (CO2) pneumoperitoneum on optic nerve sheath diameter (ONSD) and intracranial pressure (ICP) in patients undergoing total laparoscopic hysterectomy. Previous research suggests that pneumoperitoneum can lead to elevated ICP, with the standard intracranial monitoring technique being invasive intraventricular catheter placement. In contrast, bedside ultrasound assessment of ONSD offers a noninvasive alternative for detecting increased ICP.
Methods: The Hypothesize will be standard gas insufflation pressure significantly increases ONSD, while low-pressure insufflation will maintain ONSD levels. The primary aim is to compare ONSD variations pre- and post-CO2 insufflation in patients subjected to both low-pressure and standard-pressure laparoscopic surgery. Secondary aims include evaluating end-tidal CO2 measurements between the two groups.
Read the detailed description
It has been shown in many studies that pneumoperitoneum containing carbon dioxide (CO2) during laparoscopy increases intracranial pressure (ICP). (1) Evaluation of the Effect of Intraabdominal Pressure on Optic Nerve Sheath Diameter in Patients Undergoing Total Laparoscopic Hysterectomy. The standard technique for monitoring ICP is the placement of an intraventricular catheter connected to an external pressure transducer. (2) Bedside evaluation of optic nerve sheath diameter (ONSD) with ultrasound technique is a more practical and noninvasive method used to determine high ICP (>20 mmHg). The anatomical continuity of the dura with the optic nerve sheath (ONSD) allows the use of this technology, and thus an increase in ICP can be transmitted from the subarachnoid space to the ONSD. (3)
Low-pressure pneumoperitoneum reduces analgesic consumption after laparoscopic cholecystectomy in studies, but the effect of standard and low intraabdominal pressures on ICP has not yet been clarified. (4)
In our thesis, assuming that standard gas insufflation pressure will increase ONSD, but low gas insufflation pressure will not cause a change, the primary aim was to compare ONSD between two groups of low-pressure and standard-pressure laparoscopic surgery before and after CO2 insufflation preoperatively. Second, the end-tidal CO2 measurements between the two groups will be evaluated.
- Conditions
- ONSD in Laparoscopic Surgery
- Being tested
- Using low or standart pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using low or standart pressureProcedure or surgery
Written consent will be obtained before the randomized study. Randomization will be done on the computer using a software program. Participants will be divided into two groups. Patients in Group S will undergo laparoscopy under standard pressures (12-16 mmHg) in laparoscopic surgery, while patients in Group L will undergo laparoscopy under low pressure (8-10 mm Hg).
| Study group | Role | What they receive |
|---|---|---|
| Low pressure | Active comparator | Group L will undergo laparoscopy under low pressure (8-10mm Hg). Receives: Procedure: Using low or standart pressure |
| Standart Pressure | Sham comparator | Standard pressures (12-16 mmHg) are used in laparoscopic surgery for patients in Group S. Receives: Procedure: Using low or standart pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter
For the measurement of ONSD (Optic Nerve Sheath Diameter) a portable, software controlled, ultrasonographic system (Micromax Ultrasound System, SonoSitelnc. Bothell, Washington, USA) 13-6 MHz 38 mm wide band linear array transducer will be used. The probe positioning will be done in the axial plane over the closed eye and ONSD will be determined by the two hyperechoic lines on the back. The outer limits will be determined by electronic calipers as hyperechoic lines behind the 3 papillae. Measurements will be taken from each eye in all patients. In order to neutralize the intraoperative variability, the average of these measurements will be taken.
Measured: 5 min after intubation (T1). Intra-abdominal 10 min (T2) and 10 min after positioning (T3)
Secondary outcomes (1)
CO2 measurements
Secondary will be the evaluation of end tidal CO2 measurements between the two groups.
Measured: after 5 minutes (T1) 10 minutes (T2), 10 minutes after position (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start21 Oct 2024
- Primary completion5 Jan 2025
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ONSD in Laparoscopic SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Tire, MD, Konya City Hospital
- Investigators
- Yasin Tire, Assoc. Prof., Study director, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650475
- Sponsor's protocol ID
- Study Pedlap
- Status last verified
- Jan 2025
- First submitted
- 18 Oct 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Optic Nerve Sheath Diameter in Children Undergoing Laparoscopic Abdominal Surgery at Low and Standard Gas Insufflation Pressures
- ClinicalTrials.gov ID
- NCT06650475
- Acronym / sponsor ID
- Study Pedlap
- Conditions
- ONSD in Laparoscopic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 5 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 21 Oct 2024 (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.
Objective: This study investigates the impact of carbon dioxide (CO2) pneumoperitoneum on optic nerve sheath diameter (ONSD) and intracranial pressure (ICP) in patients undergoing total laparoscopic hysterectomy. Previous research suggests that pneumoperitoneum can lead to elevated ICP, with the standard intracranial monitoring technique being invasive intraventricular catheter placement. In contrast, bedside ultrasound assessment of ONSD offers a noninvasive alternative for detecting increased ICP.
Methods: The Hypothesize will be standard gas insufflation pressure significantly increases ONSD, while low-pressure insufflation will maintain ONSD levels. The primary aim is to compare ONSD variations pre- and post-CO2 insufflation in patients subjected to both low-pressure and standard-pressure laparoscopic surgery. Secondary aims include evaluating end-tidal CO2 measurements between the two groups.
Detailed description
It has been shown in many studies that pneumoperitoneum containing carbon dioxide (CO2) during laparoscopy increases intracranial pressure (ICP). (1) Evaluation of the Effect of Intraabdominal Pressure on Optic Nerve Sheath Diameter in Patients Undergoing Total Laparoscopic Hysterectomy. The standard technique for monitoring ICP is the placement of an intraventricular catheter connected to an external pressure transducer. (2) Bedside evaluation of optic nerve sheath diameter (ONSD) with ultrasound technique is a more practical and noninvasive method used to determine high ICP (>20 mmHg). The anatomical continuity of the dura with the optic nerve sheath (ONSD) allows the use of this technology, and thus an increase in ICP can be transmitted from the subarachnoid space to the ONSD. (3)
Low-pressure pneumoperitoneum reduces analgesic consumption after laparoscopic cholecystectomy in studies, but the effect of standard and low intraabdominal pressures on ICP has not yet been clarified. (4)
In our thesis, assuming that standard gas insufflation pressure will increase ONSD, but low gas insufflation pressure will not cause a change, the primary aim was to compare ONSD between two groups of low-pressure and standard-pressure laparoscopic surgery before and after CO2 insufflation preoperatively. Second, the end-tidal CO2 measurements between the two groups will be evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low pressure | Active comparator | Procedure: Using low or standart pressureGroup L will undergo laparoscopy under low pressure (8-10mm Hg). |
| Standart Pressure | Sham comparator | Procedure: Using low or standart pressureStandard pressures (12-16 mmHg) are used in laparoscopic surgery for patients in Group S. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The study will be conducted in patients under 18 years of age with American Society of Anesthesiologists (ASA) I-II.
Key exclusion criteria (1 listed)
- Patients with a history of neurological disease, glaucoma, surgery exceeding 2 hours, known chronic obstructive pulmonary disease (COPD), heart disease, and previous lung surgery will be excluded from the study. Patients with intraoperative hemodynamic problems; ETCO2 greater than 45 mmHg, plateau pressure over 30 cmH2, and peak inspiratory pressure over 35 cmH2 will be excluded from the study.
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 |
|---|---|---|
| Using low or standart pressureWritten consent will be obtained before the randomized study. Randomization will be done on the computer using a software program. Participants will be divided into two groups. Patients in Group S will undergo laparoscopy under standard pressures (12-16 mmHg) in laparoscopic surgery, while patients in Group L will undergo laparoscopy under low pressure (8-10 mm Hg). | Procedure or surgery | Low pressure, Standart Pressure |
Primary outcome
Optic nerve sheath diameter
Time frame: 5 min after intubation (T1). Intra-abdominal 10 min (T2) and 10 min after positioning (T3)
For the measurement of ONSD (Optic Nerve Sheath Diameter) a portable, software controlled, ultrasonographic system (Micromax Ultrasound System, SonoSitelnc. Bothell, Washington, USA) 13-6 MHz 38 mm wide band linear array transducer will be used. The probe positioning will be done in the axial plane over the closed eye and ONSD will be determined by the two hyperechoic lines on the back. The outer limits will be determined by electronic calipers as hyperechoic lines behind the 3 papillae. Measurements will be taken from each eye in all patients. In order to neutralize the intraoperative variability, the average of these measurements will be taken.
1 secondary outcome
CO2 measurements
Time frame: after 5 minutes (T1) 10 minutes (T2), 10 minutes after position (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
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.
Yasin Tire, Assoc. Prof. study director
Konya City Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using low or standart pressure in people with ONSD in Laparoscopic Surgery, run by Konya City Hospital at 2 sites in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Optic nerve sheath diameter (time frame: 5 min after intubation (T1). Intra-abdominal 10 min (T2) and 10 min after positioning (T3)). 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 30 Jan 2025.