MedDataX Logo

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

NCT ID: NCT04289090

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-14

Study Completion Date

2022-01-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Percentage of Change in ONSD During Anesthesia With Sevoflurane Versus Propofol in Two Groups of Patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

Group A will begin anesthesia maintenance with sevoflurane-only, then will be switched after 30 minutes to anesthesia with propofol-only.

Group Type EXPERIMENTAL

Propofol 10 MG/ML

Intervention Type DRUG

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.

Group B

Group B will begin anesthesia with propofol-only then will be switched to sevoflurane-only.

Group Type EXPERIMENTAL

Sevoflurane Inhalant Product

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

State University of New York - Downstate Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SUNY Downstate Medical Center

Brooklyn, New York, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gina Subtirelu, MD

Role: CONTACT

Phone: 516-241-5038

Email: [email protected]

Mauricia C Victor, MS,MPH

Role: CONTACT

Phone: 718-270-1937

Email: [email protected]

References

Explore related publications, articles, or registry entries linked to this study.

Lee LA. Perioperative visual loss and anesthetic management. Curr Opin Anaesthesiol. 2013 Jun;26(3):375-81. doi: 10.1097/ACO.0b013e328360dcd9.

Reference Type BACKGROUND
PMID: 23614957 (View on PubMed)

Moretti R, Pizzi B. Ultrasonography of the optic nerve in neurocritically ill patients. Acta Anaesthesiol Scand. 2011 Jul;55(6):644-52. doi: 10.1111/j.1399-6576.2011.02432.x. Epub 2011 Apr 4.

Reference Type BACKGROUND
PMID: 21463263 (View on PubMed)

Blecha S, Harth M, Schlachetzki F, Zeman F, Blecha C, Flora P, Burger M, Denzinger S, Graf BM, Helbig H, Pawlik MT. Changes in intraocular pressure and optic nerve sheath diameter in patients undergoing robotic-assisted laparoscopic prostatectomy in steep 45 degrees Trendelenburg position. BMC Anesthesiol. 2017 Mar 11;17(1):40. doi: 10.1186/s12871-017-0333-3.

Reference Type BACKGROUND
PMID: 28284189 (View on PubMed)

Tranquart F, Berges O, Koskas P, Arsene S, Rossazza C, Pisella PJ, Pourcelot L. Color Doppler imaging of orbital vessels: personal experience and literature review. J Clin Ultrasound. 2003 Jun;31(5):258-73. doi: 10.1002/jcu.10169.

Reference Type BACKGROUND
PMID: 12767021 (View on PubMed)

Riaz R, Khuba S, Shamim R, Patro A. Ultrasonographic optic nerve sheath diameter measurement in overweight parturient with intracranial tumour: Guiding choice of anaesthesia. Indian J Anaesth. 2016 Oct;60(10):775-777. doi: 10.4103/0019-5049.191701. No abstract available.

Reference Type BACKGROUND
PMID: 27761045 (View on PubMed)

Banerjee A, Bala R, Saini S. Ultrasonographic measurement of optic nerve sheath diameter: A point of care test helps in prognostication of Intensive Care Unit patients. Indian J Anaesth. 2017 Mar;61(3):262-265. doi: 10.4103/ija.IJA_473_16.

Reference Type BACKGROUND
PMID: 28405042 (View on PubMed)

Tayal VS, Neulander M, Norton HJ, Foster T, Saunders T, Blaivas M. Emergency department sonographic measurement of optic nerve sheath diameter to detect findings of increased intracranial pressure in adult head injury patients. Ann Emerg Med. 2007 Apr;49(4):508-14. doi: 10.1016/j.annemergmed.2006.06.040. Epub 2006 Sep 25.

Reference Type BACKGROUND
PMID: 16997419 (View on PubMed)

Kim JY, Min HG, Ha SI, Jeong HW, Seo H, Kim JU. Dynamic optic nerve sheath diameter responses to short-term hyperventilation measured with sonography in patients under general anesthesia. Korean J Anesthesiol. 2014 Oct;67(4):240-5. doi: 10.4097/kjae.2014.67.4.240. Epub 2014 Oct 27.

Reference Type BACKGROUND
PMID: 25368781 (View on PubMed)

Robba C, Cardim D, Donnelly J, Bertuccio A, Bacigaluppi S, Bragazzi N, Cabella B, Liu X, Matta B, Lattuada M, Czosnyka M. Effects of pneumoperitoneum and Trendelenburg position on intracranial pressure assessed using different non-invasive methods. Br J Anaesth. 2016 Dec;117(6):783-791. doi: 10.1093/bja/aew356.

Reference Type BACKGROUND
PMID: 27956677 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1281970-5

Identifier Type: -

Identifier Source: org_study_id