Clinical trial NCT04289090: Sevoflurane Versus Propofol on Optic Nerve Sheath Diameter During Anesthesia in Steep Trendelenburg Position
Official title: Sevoflurane Versus Propofol on Optic Nerve Sheath Diameter During Anesthesia in Steep Trendelenburg Position
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Percentage of Change in ONSD During Anesthesia With Sevoflurane Versus Propofol in Two Groups of Patients
Lead sponsor: State University of New York - Downstate Medical Center
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Sevoflurane Versus Propofol on Optic Nerve Sheath Diameter During Anesthesia in Steep Trendelenburg Position
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
Study officials:
References:
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citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.