NCT06896604

Brief Summary

In this study, the investigators to observe the effects of different fresh gas flow rates, which are frequently used in general anesthesia practice, on optic nerve sheath diameter during laparoscopic cholecystectomy surgeries under general anesthesia with desflurane.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

March 18, 2025

Last Update Submit

April 15, 2025

Conditions

Keywords

Low Fresh Gas Flow, DesfluraneDesfluraneCholecystectomy, LaparoscopicSpectroscopy, Near-InfraredOptic Nerve Sheath Diameter Sonography

Outcome Measures

Primary Outcomes (1)

  • Ultrasonographic Measurement of Optic Nerve Sheath Diameter for Observing Intracranial Pressure Increase

    Investigation of the Effects of Desflurane Administration with Different Fresh Gas Flow Rates on Optic Nerve Sheath Diameter

    through study completion, an average of 2 months

Secondary Outcomes (1)

  • Monitoring Cerebral Perfusion Using Near-Infrared Spectroscopy

    through study completion, an average of 2 months

Study Arms (2)

low flow anesthesia with desflurane

After standard induction procedures, the fresh gas flow was reduced to 1 L/min during the maintenance phase of inhalation anesthesia with desflurane.

Device: Ocular Ultrasonography for measuring Optic Nerve Sheath Diameter

high flow anesthesia with desflurane

After standard induction procedures, the fresh gas flow was set to 3 L/min during the maintenance phase of inhalation anesthesia with desflurane.

Device: Ocular Ultrasonography for measuring Optic Nerve Sheath Diameter

Interventions

In the study, the investigators measured the optic nerve sheath diameter to observe its effects on intracranial pressure and used ocular ultrasonography for this measurement.

high flow anesthesia with desfluranelow flow anesthesia with desflurane

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 18-65 years with an American Society of Anesthesiologists (ASA) physical status classification of I-III and a body mass index (BMI) \< 35 kg/m², undergoing elective laparoscopic cholecystectomy under general anesthesia.

You may qualify if:

  • Patients Undergoing Elective Laparoscopic Cholecystectomy Under General Anesthesia
  • Patients aged 18-65 years with an American Society of Anesthesiologists (ASA) physical status classification of I-III and a body mass index (BMI) \< 35 kg/m²
  • Patients who have provided informed consent

You may not qualify if:

  • Patients under 18 or over 65 years old, those classified as ASA IV-V, or with a BMI ≥ 35 kg/m²
  • Patients with conditions that may lead to increased intracranial pressure (e.g., intracranial mass, aneurysm, head trauma), a history of intracranial surgery, previous ischemic or hemorrhagic stroke, or neurological diseases
  • Patients with a history of glaucoma or cataract surgery
  • Patients undergoing emergency surgical procedures
  • Patients with severe cardiac, renal, pulmonary, or hepatic failure
  • Patients who do not provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Atasehir, 34752, Turkey (Türkiye)

Location

Related Publications (8)

  • Geeraerts T, Merceron S, Benhamou D, Vigue B, Duranteau J. Non-invasive assessment of intracranial pressure using ocular sonography in neurocritical care patients. Intensive Care Med. 2008 Nov;34(11):2062-7. doi: 10.1007/s00134-008-1149-x. Epub 2008 May 29.

  • Akbas S, Ozkan AS. Comparison of effects of low-flow and normal-flow anesthesia on cerebral oxygenation and bispectral index in morbidly obese patients undergoing laparoscopic sleeve gastrectomy: a prospective, randomized clinical trial. Wideochir Inne Tech Maloinwazyjne. 2019 Jan;14(1):19-26. doi: 10.5114/wiitm.2018.77265. Epub 2018 Jul 24.

  • Choi ES, Jeon YT, Sohn HM, Kim DW, Choi SJ, In CB. Comparison of the effects of desflurane and total intravenous anesthesia on the optic nerve sheath diameter in robot assisted laparoscopic radical prostatectomy: A randomized controlled trial. Medicine (Baltimore). 2018 Oct;97(41):e12772. doi: 10.1097/MD.0000000000012772.

  • Oterkus M, Donmez I, Nadir AH, Rencuzogullari I, Karabag Y, Binnetoglu K. The effect of low flow anesthesia on hemodynamic and peripheral oxygenation parameters in obesity surgery. Saudi Med J. 2021 Mar;42(3):264-269. doi: 10.15537/smj.2021.42.3.20200575.

  • Tekin EA, Gultop F, Baskurt NA. Minimal and normal-flow general anesthesia in patients undergoing surgery in prone position: impact on hemodynamics and regional cerebral oxygenation. Acta Cir Bras. 2023 Mar 24;38:e380523. doi: 10.1590/acb380523. eCollection 2023.

  • Bingol Tanriverdi T, Tercan M, Gusun Halitoglu A, Kaya A, Patmano G. Comparison of the Effects of Low-flow and Normal-flow Desflurane Anaesthesia on Inflammatory Parameters in Patients Undergoing Laparoscopic Cholecystectomy. Turk J Anaesthesiol Reanim. 2021 Feb;49(1):18-24. doi: 10.5152/TJAR.2020.30. Epub 2020 Nov 30.

  • Bedforth NM, Hardman JG, Nathanson MH. Cerebral hemodynamic response to the introduction of desflurane: A comparison with sevoflurane. Anesth Analg. 2000 Jul;91(1):152-5. doi: 10.1097/00000539-200007000-00028.

  • Jiang Z, Wu Y, Liang F, Jian M, Liu H, Mei H, Han R. Brain relaxation using desflurane anesthesia and total intravenous anesthesia in patients undergoing craniotomy for supratentorial tumors: a randomized controlled study. BMC Anesthesiol. 2023 Jan 10;23(1):15. doi: 10.1186/s12871-023-01970-z.

Study Officials

  • Oznur Demiroluk, As Prof

    Fatih Sultan Mehmet Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

March 18, 2025

First Posted

March 26, 2025

Study Start

February 1, 2025

Primary Completion

April 1, 2025

Study Completion

April 15, 2025

Last Updated

April 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations