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

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Hypertension
• Intervention / Treatment: Procedure: Low flow technique in general anesthesia

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Karatay
    • Konya, Karatay, Turkey, 42020
      • Konya City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intraoperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional cerebral oxygen saturation (rSO2)	Seconder outcome 1 is regional cerebral oxygen saturation (rSO2) between low and normal flow technique.	Intraoperative period
Bispectral index (BIS)	Seconder outcome 2 is bispectral index (BIS) between low and normal flow technique.	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.	Perioperative period.

Collaborators and Investigators

• Sponsor: Konya City Hospital
• Investigators: Principal Investigator: Aydın Mermer, MD, Konya City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2023
• Primary Completion (Actual): June 20, 2023
• Study Completion (Actual): June 25, 2023

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: intracranial pressure; laparoscopic cholecystectomy; Low flow anesthesia; optic sheath diameter
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2023/4146 (12662)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No