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Sevoflurane Versus Propofol on Optic Nerve Sheath Diameter During Anesthesia in Steep Trendelenburg Position

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ClinicalTrials.gov Identifier: NCT04289090
Recruitment Status : Recruiting
First Posted : February 28, 2020
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
State University of New York - Downstate Medical Center

Brief Summary:
We will prospectively compare change in ONSD during anesthesia with sevoflurane-only versus anesthesia with propofol-only in two groups of patients undergoing urologic and gynecologic surgery in the steep Trendelenburg position. We hypothesize that there will be a significant decrease in the size of ONSD during transition from sevoflurane-only anesthesia to propofol-only anesthesia.

Condition or disease Intervention/treatment Phase
Percentage of Change in ONSD During Anesthesia With Sevoflurane Versus Propofol in Two Groups of Patients Drug: Sevoflurane Inhalant Product Drug: Propofol 10 MG/ML Phase 4

Detailed Description:

Steep Trendelenburg positioning is required for optimal surgical exposure for certain procedures, including robotic assisted laparoscopic urologic and gynecologic procedures. The position is associated with increased intracranial pressure (ICP) and its complications such as post-operative vision loss (POVL) and post-op delirium [Lee 2013]. Therefore, it is essential to measure ICP intra-operatively in order to implement real time management. The gold standard for ICP measurement is an external ventricular drain (EVD). However, it is invasive and not practical for the majority of non-neurosurgical procedures. Trans-ocular ultrasound measurement of Optic nerve sheath diameter (ONSD) is a non-invasive alternative for ICP measurement [Tayal et al 2007; Nash et al 2016]. Compared to EVD it is non-invasive, less expensive and efficient. It has been validated as a screening tool for identification of patients with elevated ICP who required treatment in several larger studies [Nash et al 2016; Blecha et al 2017]. During these procedures prior pre-cautions to prevent increased ICP focused on fluid restriction/selection. Ultrasound measurement of ONSD has not been routinely employed. Furthermore, consideration has rarely been given to the benefits of total intravenous anesthesia (TIVA) rather than volatile anesthetics for anesthesia maintenance during these procedures. Considering the complications of increased ICP, sonographic measurement could prove to be a practical method to efficiently monitor the ICP surrogate [Riaz et al 2016; Nash et al 2016; Banerjee et al 2017]. This study will perform intra-operative sonographic ONSD measurements in order to compare the change in ONSD during transition from inhalational maintenance anesthesia (using sevoflurane) to total intravenous anesthesia (TIVA) using propofol.

While other studies have demonstrated that the use of pneumoperitoneum and steep Trendelenburg positioning can lead to an increase in ICP as determined by use of ONSD (Robba et al. 2016), this study describes the added role of ONSD measurement for guiding the choice of anesthesia maintenance (TIVA vs sevoflurane) during surgery in the steep-Trendelenburg position.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group A will begin anesthesia maintenance with sevoflurane-only, then will be switched after 30 minutes to anesthesia with propofol-only. Group B will begin anesthesia with propofol-only then will be switched to sevoflurane-only.
Masking: Single (Participant)
Masking Description: Group A will begin anesthesia maintenance with sevoflurane-only, then will be switched after 30 minutes to anesthesia with propofol-only. Group B will begin anesthesia with propofol-only then will be switched to sevoflurane-only.
Primary Purpose: Prevention
Official Title: Sevoflurane Versus Propofol on Optic Nerve Sheath Diameter During Anesthesia in Steep Trendelenburg Position
Actual Study Start Date : January 14, 2020
Estimated Primary Completion Date : January 17, 2022
Estimated Study Completion Date : January 17, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
Group A will begin anesthesia maintenance with sevoflurane-only, then will be switched after 30 minutes to anesthesia with propofol-only.
Drug: Propofol 10 MG/ML
This study will perform intra-operative sonographic ONSD measurements in order to compare the change in ONSD during transition from inhalational maintenance anesthesia (using sevoflurane) to total intravenous anesthesia (TIVA) using propofol.

Experimental: Group B
Group B will begin anesthesia with propofol-only then will be switched to sevoflurane-only.
Drug: Sevoflurane Inhalant Product
This study will perform intra-operative sonographic ONSD measurements in order to compare the change in ONSD during transition from inhalational maintenance anesthesia (using sevoflurane) to total intravenous anesthesia (TIVA) using propofol.




Primary Outcome Measures :
  1. Sevoflurane Versus Propofol on Optic Nerve Sheath Diameter During Anesthesia in Steep Trendelenburg Position [ Time Frame: 2 years ]
    1. Percentage of change in ONSD during anesthesia with sevoflurane-only versus propofol-only in two groups of patients undergoing urologic and gynecologic surgery in the steep Trendelenburg position.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All patients scheduled to undergo surgery in the steep Trendelenburg position at SUNY Downstate Medical Center.

Exclusion Criteria:

< 18 years old Pregnancy Pre-existing eye disease Prior ophthalmic surgery Inability to tolerate steep Trendelenburg position Patient refusal


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04289090


Contacts
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Contact: Gina Subtirelu, MD 516-241-5038 gina.subtirelu@downstate.edu
Contact: Mauricia C Victor, MS,MPH 718-270-1937 mauricia.victor@downstate.edu

Locations
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United States, New York
SUNY Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203-2098
Sponsors and Collaborators
State University of New York - Downstate Medical Center
Publications:

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Responsible Party: State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier: NCT04289090    
Other Study ID Numbers: 1281970-5
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Propofol
Sevoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation