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

Sponsor

Konya City Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05946200

Collaborator

(none)

Enrollment

Location

Arms

1.2

Actual Duration (Months)

67.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Hypertension	Procedure: Low flow technique in general anesthesia	N/A

Detailed Description

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

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, 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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 20, 2023

Actual Primary Completion Date :

Jun 20, 2023

Actual Study Completion Date :

Jun 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Low flow It will be used low-flow (0.75 l/min) to manage the general anesthesia.	Procedure: Low 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.
Sham Comparator: Normal flow It will be used normal-flow (1.5 l/min) to manage the general anesthesia.	Procedure: Low 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.

Arm

Intervention/Treatment

Active Comparator: Low flow

It will be used low-flow (0.75 l/min) to manage the general anesthesia.

Procedure: Low 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.

Sham Comparator: Normal flow

It will be used normal-flow (1.5 l/min) to manage the general anesthesia.

Procedure: Low 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.

Outcome Measures

Primary Outcome Measures

Optic nerve sheath diameter. [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.