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

Primary Purpose

Intracranial Hypertension

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Low flow technique in general anesthesia
Sponsored by
Konya City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intracranial Hypertension focused on measuring Low flow anesthesia, optic sheath diameter, intracranial pressure, laparoscopic cholecystectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Konya City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Low flow

Normal flow

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 2, 2023
Last Updated
July 20, 2023
Sponsor
Konya City Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05946200
Brief Title
Optic Nerve Sheath Diameter in Low-flow and Normal-flow Rate Anesthesia
Official Title
Comparison of the Effects of Low-flow and Normal-flow on Intracranial Pressure, Cerebral Oxygenation, and Bispectral Index in Laparoscopic Cholecystectomy Operation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 20, 2023 (Actual)
Primary Completion Date
June 20, 2023 (Actual)
Study Completion Date
June 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya City Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Hypertension
Keywords
Low flow anesthesia, optic sheath diameter, intracranial pressure, laparoscopic cholecystectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low flow
Arm Type
Active Comparator
Arm Description
It will be used low-flow (0.75 l/min) to manage the general anesthesia.
Arm Title
Normal flow
Arm Type
Sham Comparator
Arm Description
It will be used normal-flow (1.5 l/min) to manage the general anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Low flow technique in general anesthesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Optic nerve sheath diameter.
Description
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.
Time Frame
Intraoperative period
Secondary Outcome Measure Information:
Title
Regional cerebral oxygen saturation (rSO2)
Description
Seconder outcome 1 is regional cerebral oxygen saturation (rSO2) between low and normal flow technique.
Time Frame
Intraoperative period
Title
Bispectral index (BIS)
Description
Seconder outcome 2 is bispectral index (BIS) between low and normal flow technique.
Time Frame
Intraoperative period
Title
Cognitive function assessment by using Mini mental test
Description
Seconder aim 3 is to get Mini mental test score in the postoperative 24th.hours.
Time Frame
Perioperative period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aydın Mermer, MD
Organizational Affiliation
Konya City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Konya City Hospital
City
Konya
State/Province
Karatay
ZIP/Postal Code
42020
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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