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Optic Nerve Sheath Diameter in Low-flow and Normal-flow Rate Anesthesia

Comparison of the Effects of Low-flow and Normal-flow on Intracranial Pressure, Cerebral Oxygenation, and Bispectral Index in Laparoscopic Cholecystectomy Operation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05946200
Enrollment
80
Registered
2023-07-14
Start date
2023-05-20
Completion date
2023-06-25
Last updated
2023-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Hypertension

Keywords

Low flow anesthesia, optic sheath diameter, intracranial pressure, laparoscopic cholecystectomy

Brief 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. 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.

Interventions

PROCEDURELow flow technique in general anesthesia

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.

Sponsors

Konya City Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Only the care provider will know what's going on in the management of the patient. Cause that they should manage the case properly.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Inclusion criteria of the patients will be determined as age between 18 and 65 years, ASA status 1-2.

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Optic nerve sheath diameter.Intraoperative periodThe 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.

Secondary

MeasureTime frameDescription
Regional cerebral oxygen saturation (rSO2)Intraoperative periodSeconder outcome 1 is regional cerebral oxygen saturation (rSO2) between low and normal flow technique.
Bispectral index (BIS)Intraoperative periodSeconder outcome 2 is bispectral index (BIS) between low and normal flow technique.
Cognitive function assessment by using Mini mental testPerioperative period.Seconder aim 3 is to get Mini mental test score in the postoperative 24th.hours.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026