Intracranial HypertensionNCT05946200
Optic Nerve Sheath Diameter in Low-flow and Normal-flow Rate Anesthesia
A study testing Low flow technique in general anesthesia in people with Intracranial Hypertension, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy is one of the regularly performed laparoscopic surgical procedures. It resulted in shorter hospital stays, improved cosmetic outcomes, and reduced bleeding and pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intracranial Hypertension
- What is being tested?
- Low flow technique in general anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2023to 25 Jun 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria of the patients will be determined as age between 18 and 65 years, ASA status 1-2.
Who cannot join
- Exclusion criteria of the patients are defined as patients younger than 18, pregnant women, patients with any ophthalmological disease affecting optic nerve diameters, patients with acute or chronic eye disease, patients using drugs known to affect intracranial pressure, and patients abusing alcohol or psychoactive substances.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Low-flow and Normal-flow on Intracranial Pressure, Cerebral Oxygenation, and Bispectral Index in Laparoscopic Cholecystectomy Operation
Laparoscopic cholecystectomy is one of the regularly performed laparoscopic surgical procedures. It resulted in shorter hospital stays, improved cosmetic outcomes, and reduced bleeding and pain. However, during laparoscopic surgeries, the pneumoperitoneum is known to raise intracranial pressure (ICP), reduction in cerebral blood flow (CBF), and as a consequence, cerebral hypoxia. There are various possible advantages of low-flow anesthesia. During laparoscopic procedures, low-flow anesthesia may be used as a means of preventing a rise in intracranial pressure and cerebral hypoxia. But low flow anesthesia effects on İCP are not known in Laparoscopic cholecystectomy. The primary aim of this study is to compare the effects of low-flow (0.75 l/min) and normal-flow (1.5 l/min) anesthesia on ONSD in patients undergoing laparoscopic cholecystectomy. Seconder aims are regional cerebral oxygen saturation (rSO2), bispectral index (BIS), and evaluate the status of cognitive function in the postoperative 24th hours.
Read the detailed description
Laparoscopic cholecystectomy is one of the regularly performed laparoscopic surgical procedures. It resulted in shorter hospital stays, improved cosmetic outcomes, and reduced bleeding and pain. However, during laparoscopic surgeries, the pneumoperitoneum is known to raise intracranial pressure (ICP), reduction in cerebral blood flow (CBF), and as a consequence, cerebral hypoxia.
Near-infrared spectroscopy (NIRS), a noninvasive and continuous measuring method used to evaluate the appropriateness of cerebral perfusion, is therefore utilized in conjunction with cerebral oximetry to quantify regional tissue oxygenation. On the other, BIS is the most reliable technique for determining the level of sedation and anesthesia. Patients experience fewer intraoperative wake-ups thanks to BIS monitoring. Increased intra-abdominal pressure, decreased cerebrospinal fluid (CSF) absorption and obstruction of lumbar venous plexus drainage, increased pressure in the sacral spaces' vascular compartment, and cerebral vasodilation brought on by hypercarbia are some of the suggested mechanisms for why ICP increases during laparoscopy. Intraventricular and intraparenchymal catheterization remains the gold standard for determining and monitoring ICP. However, due to worries about severe complications like bleeding, infection, and equipment failure, invasive ICP monitoring during laparoscopic surgery is almost impossible. Recently, ultrasound-guided optic nerve sheath diameter (ONSD) measurement is a simple and reliable method of predicting elevated ICP.
There are various possible advantages of low-flow anesthesia. It boosts mucociliary clearance, preserves body temperature, lessens fluid loss, generates savings of up to 75%, and lowers greenhouse gas emissions as well as the cost of treatment. It also improves the flow dynamics of the breathed air. During laparoscopic procedures, low-flow anesthesia may be used as a means of preventing a rise in intracranial pressure and cerebral hypoxia. But low flow anesthesia effects on İCP are not known in Laparoscopic cholecystectomy.
The primary aim of this study is to compare the effects of low-flow (0.75 l/min) and normal-flow (1.5 l/min) anesthesia on ONSD in patients undergoing laparoscopic cholecystectomy. Seconder aims are regional cerebral oxygen saturation (rSO2), bispectral index (BIS), and evaluate the status of cognitive function in the postoperative 24th hours.
- Conditions
- Intracranial Hypertension
- Being tested
- Low flow technique in general anesthesia
- Keywords
- Low flow anesthesia, optic sheath diameter, intracranial pressure, laparoscopic cholecystectomy
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low flow technique in general anesthesiaProcedure or surgery
It will be used a low flow technique by giving airflow as 0.75 l/min after the intubation and will keep going on until the end of the laparoscopic cholecystectomy.
| Study group | Role | What they receive |
|---|---|---|
| Low flow | Active comparator | It will be used low-flow (0.75 l/min) to manage the general anesthesia. Receives: Procedure: Low flow technique in general anesthesia |
| Normal flow | Sham comparator | It will be used normal-flow (1.5 l/min) to manage the general anesthesia. Receives: Procedure: Low flow technique in general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve sheath diameter.
The primer outcome of this study is to measure optic nerve sheath diameter during by using low-flow (0.75 l/min) and normal-flow (1.5 l/min) anesthesia on ONSD in patients undergoing laparoscopic cholecystectomy.
Measured: Intraoperative period
Secondary outcomes (3)
Regional cerebral oxygen saturation (rSO2)
Seconder outcome 1 is regional cerebral oxygen saturation (rSO2) between low and normal flow technique.
Measured: Intraoperative period
Bispectral index (BIS)
Seconder outcome 2 is bispectral index (BIS) between low and normal flow technique.
Measured: Intraoperative period
Cognitive function assessment by using Mini mental test
Seconder aim 3 is to get Mini mental test score in the postoperative 24th.hours.
Measured: Perioperative period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start20 May 2023
- Primary completion20 Jun 2023
- Study completion25 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HypertensionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aydın Mermer, Konya City Hospital
- Investigators
- Aydın Mermer, MD, Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946200
- Sponsor's protocol ID
- 2023/4146 (12662)
- Status last verified
- Jul 2023
- First submitted
- 2 Jun 2023
- Last updated
- 21 Jul 2023
- 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 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Low-flow and Normal-flow on Intracranial Pressure, Cerebral Oxygenation, and Bispectral Index in Laparoscopic Cholecystectomy Operation
- ClinicalTrials.gov ID
- NCT05946200
- Acronym / sponsor ID
- 2023/4146 (12662)
- Conditions
- Intracranial Hypertension
- Keywords
- Low flow anesthesia, optic sheath diameter, intracranial pressure, laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 20 May 2023 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 25 Jun 2023 (actual)
- First posted
- 14 Jul 2023 (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.
Laparoscopic cholecystectomy is one of the regularly performed laparoscopic surgical procedures. It resulted in shorter hospital stays, improved cosmetic outcomes, and reduced bleeding and pain. However, during laparoscopic surgeries, the pneumoperitoneum is known to raise intracranial pressure (ICP), reduction in cerebral blood flow (CBF), and as a consequence, cerebral hypoxia. There are various possible advantages of low-flow anesthesia. During laparoscopic procedures, low-flow anesthesia may be used as a means of preventing a rise in intracranial pressure and cerebral hypoxia. But low flow anesthesia effects on İCP are not known in Laparoscopic cholecystectomy. The primary aim of this study is to compare the effects of low-flow (0.75 l/min) and normal-flow (1.5 l/min) anesthesia on ONSD in patients undergoing laparoscopic cholecystectomy. Seconder aims are regional cerebral oxygen saturation (rSO2), bispectral index (BIS), and evaluate the status of cognitive function in the postoperative 24th hours.
Detailed description
Laparoscopic cholecystectomy is one of the regularly performed laparoscopic surgical procedures. It resulted in shorter hospital stays, improved cosmetic outcomes, and reduced bleeding and pain. However, during laparoscopic surgeries, the pneumoperitoneum is known to raise intracranial pressure (ICP), reduction in cerebral blood flow (CBF), and as a consequence, cerebral hypoxia.
Near-infrared spectroscopy (NIRS), a noninvasive and continuous measuring method used to evaluate the appropriateness of cerebral perfusion, is therefore utilized in conjunction with cerebral oximetry to quantify regional tissue oxygenation. On the other, BIS is the most reliable technique for determining the level of sedation and anesthesia. Patients experience fewer intraoperative wake-ups thanks to BIS monitoring. Increased intra-abdominal pressure, decreased cerebrospinal fluid (CSF) absorption and obstruction of lumbar venous plexus drainage, increased pressure in the sacral spaces' vascular compartment, and cerebral vasodilation brought on by hypercarbia are some of the suggested mechanisms for why ICP increases during laparoscopy. Intraventricular and intraparenchymal catheterization remains the gold standard for determining and monitoring ICP. However, due to worries about severe complications like bleeding, infection, and equipment failure, invasive ICP monitoring during laparoscopic surgery is almost impossible. Recently, ultrasound-guided optic nerve sheath diameter (ONSD) measurement is a simple and reliable method of predicting elevated ICP.
There are various possible advantages of low-flow anesthesia. It boosts mucociliary clearance, preserves body temperature, lessens fluid loss, generates savings of up to 75%, and lowers greenhouse gas emissions as well as the cost of treatment. It also improves the flow dynamics of the breathed air. During laparoscopic procedures, low-flow anesthesia may be used as a means of preventing a rise in intracranial pressure and cerebral hypoxia. But low flow anesthesia effects on İCP are not known in Laparoscopic cholecystectomy.
The primary aim of this study is to compare the effects of low-flow (0.75 l/min) and normal-flow (1.5 l/min) anesthesia on ONSD in patients undergoing laparoscopic cholecystectomy. Seconder aims are regional cerebral oxygen saturation (rSO2), bispectral index (BIS), and evaluate the status of cognitive function in the postoperative 24th hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low flow | Active comparator | Procedure: Low flow technique in general anesthesiaIt will be used low-flow (0.75 l/min) to manage the general anesthesia. |
| Normal flow | Sham comparator | Procedure: Low flow technique in general anesthesiaIt will be used normal-flow (1.5 l/min) to manage the general anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria of the patients will be determined as age between 18 and 65 years, ASA status 1-2.
Key exclusion criteria (1 listed)
- Exclusion criteria of the patients are defined as patients younger than 18, pregnant women, patients with any ophthalmological disease affecting optic nerve diameters, patients with acute or chronic eye disease, patients using drugs known to affect intracranial pressure, and patients abusing alcohol or psychoactive substances.
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 |
|---|---|---|
| Low flow technique in general anesthesiaIt will be used a low flow technique by giving airflow as 0.75 l/min after the intubation and will keep going on until the end of the laparoscopic cholecystectomy. | Procedure or surgery | Low flow, Normal flow |
Primary outcome
Optic nerve sheath diameter.
Time frame: Intraoperative period
The primer outcome of this study is to measure optic nerve sheath diameter during by using low-flow (0.75 l/min) and normal-flow (1.5 l/min) anesthesia on ONSD in patients undergoing laparoscopic cholecystectomy.
3 secondary outcomes
Regional cerebral oxygen saturation (rSO2)
Time frame: Intraoperative period
Bispectral index (BIS)
Time frame: Intraoperative period
Cognitive function assessment by using Mini mental test
Time frame: Perioperative period.
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 21 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Intracranial Hypertension
Not yet recruitingObservational study
Decompressive Craniectomy After Aneurysmal Subarachnoid Hemorrhage (DECIDE-SAH)
Aneurysmal Subarachnoid Hemorrhage
Active, not recruiting
aSAH Treatment Based on Intraventricular ICP Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial
Aneurysmal Subarachnoid Hemorrhage, Intacranial Hypertension
Not yet recruitingObservational study
TCD and ONSD for Early Risk Stratification of Traumatic Brain Injury
Traumatic Brain Injury
RecruitingPhase 4
Tirzepatide in Idiopathic Intracranial Hypertension Trial
Idiopathic Intracranial Hypertension (IIH)
Active, not recruitingObservational study
TCD and ONSD for Noninvasive Assessment of Increased ICP in TBI
Intracranial Pressure Increase, Traumatic Brain Injuries
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.
Aydın Mermer, MD principal investigator
Konya City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low flow technique in general anesthesia in people with Intracranial Hypertension, run by Konya City Hospital at 1 site 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 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: Intraoperative period). 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 21 Jul 2023.