- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04289090
Sevoflurane Versus Propofol on Optic Nerve Sheath Diameter During Anesthesia in Steep Trendelenburg Position
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
New York
-
Brooklyn, New York, United States, 11203-2098
- Recruiting
- SUNY Downstate Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Lee LA. Perioperative visual loss and anesthetic management. Curr Opin Anaesthesiol. 2013 Jun;26(3):375-81. doi: 10.1097/ACO.0b013e328360dcd9.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1281970-5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Percentage of Change in ONSD During Anesthesia With Sevoflurane Versus Propofol in Two Groups of Patients
-
Ming ZhongNot yet recruitingTo Study the Incidence of Patient-ventilator Asynchronization in Two Groups of Patients Under Two Conditions With PVA Unsynchronization Analysis Function
-
National Taiwan University HospitalUnknownTo Investigate the Change of Inter-joint Coordination and Muscle Activation in Patients With Cruciate Ligament Injury During Stair Negotiation.Taiwan
-
Baskent University Ankara HospitalUnknownTo Investigate the Incidence and Causes of Awareness During General Anesthesia | To Investigate the of Dreaming During Anesthesia | To Investigate the Intra-operative Experiences of Patients Who Report Awareness | To Investigate the Risk Factors That May be Associated With Awareness | To... and other conditionsTurkey
Clinical Trials on Propofol 10 MG/ML
-
Cuda Anesthetics, LLCCompleted
-
Novo Nordisk A/SCompleted
-
Shaheed Zulfiqar Ali Bhutto Medical UniversityCompletedCytokine Release Syndrome | Covid-19 PneumoniaPakistan
-
AmtixBio Co., Ltd.Novotech (Australia) Pty LimitedCompleted
-
Guolin WangUnknownEtomidate is Mixed With PropofolChina
-
Novo Nordisk A/SCompletedHealthy Volunteers - Haemophilia AGermany
-
Adynxx, Inc.CompletedPostsurgical PainUnited States
-
UCB Pharma SACompleted
-
Lundbeck FoundationCompletedPostoperative Pain | Analgesic EfficacyDenmark
-
Al-Balqa Applied UniversityLuzmila HospitalNot yet recruiting