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

NCT05946200 | Completed

• 1 other identifier: 2023/4146 (12662)
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Regional cerebral oxygen saturation (rSO2)

  Intraoperative period

• Bispectral index (BIS)

  Intraoperative period

• Cognitive function assessment by using Mini mental test

  Perioperative period.

Study Arms (2)

Low flow

ACTIVE COMPARATOR

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

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.

Procedure: Low flow technique in general anesthesia

Interventions

Low flow technique in general anesthesia PROCEDURE

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.

Low flow; Normal flow

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, Karatay, 42020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intracranial Hypertension

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Aydın Mermer, MD

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the care provider will know what's going on in the management of the patient. Cause that they should manage the case properly.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director, Head of Anesthesiology, Principal Investigator, Clinical Specialistsor

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: July 14, 2023
• Study Start: May 20, 2023
• Primary Completion: June 20, 2023
• Study Completion: June 25, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)