The Effect of High vs. Low Fluid Volume on Ocular Parameters in Prone Spine Surgery
NCT ID: NCT03890510
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
97 participants
INTERVENTIONAL
2019-05-01
2020-09-07
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Low PPV Group
After anesthesia induction, patients will receive spine surgery under general anesthesia in the prone position. Ringer's lactate solution will be infused at 1ml/（kg·h ） as a basal speed. Ringer's lactate solution at a volume of 250ml will be used as a bolus dose. Repeat bolus doses will be given to maintain PPV at 6\~9% when necessary. Intraoptic pressure and optic sheath diameter will be measured at multiple time points.
Ringer's Lactate solution
Patients in both groups will receive Ringer's lactate solution continuously during operation with different infusion volume.
Spine surgery under general Anesthesia in the prone position
The surgery, general anesthesia, and the placement of the prone position will be performed according to the standard procedures.
High PPV Group
After anesthesia induction, patients will receive spine surgery under general anesthesia in the prone position. Ringer's lactate solution will be infused at 1ml/（kg·h ） as a basal speed. Ringer's lactate solution at a volume of 250ml will be used as a bolus dose. Repeat bolus doses will be given to maintain PPV at 13\~16% when necessary. Intraoptic pressure and optic sheath diameter will be measured at multiple time points.
Ringer's Lactate solution
Patients in both groups will receive Ringer's lactate solution continuously during operation with different infusion volume.
Spine surgery under general Anesthesia in the prone position
The surgery, general anesthesia, and the placement of the prone position will be performed according to the standard procedures.
Interventions
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Ringer's Lactate solution
Patients in both groups will receive Ringer's lactate solution continuously during operation with different infusion volume.
Spine surgery under general Anesthesia in the prone position
The surgery, general anesthesia, and the placement of the prone position will be performed according to the standard procedures.
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) physical status I or II
* Have signed consent form
Exclusion Criteria
* Pregnancy or breast feeding
* Known Allergy to latex or Ringer's lactate solution
* Hyperlactacidemia，uncontrolled hypertension, diabetes mellitus, arrhythmia, cardiovascular disease，chronic pulmonary disease, swelling of any body part, abnormal of liver or renal function, anemia, etc.
* Body mass index（BMI）\>30
* Expected operation time \>6 hours
* Estimated Intraoperative hemorrhage \>1000ml
* Taking part in other clinical trials in the last 3 months or at present
18 Years
60 Years
ALL
No
Sponsors
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Huashan Hospital
OTHER
Responsible Party
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Xiao-Yu Yang, MD
Principal Investigator
Principal Investigators
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Xiaoyu Yang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Locations
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Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Countries
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References
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Cheng MA, Todorov A, Tempelhoff R, McHugh T, Crowder CM, Lauryssen C. The effect of prone positioning on intraocular pressure in anesthetized patients. Anesthesiology. 2001 Dec;95(6):1351-5. doi: 10.1097/00000542-200112000-00012.
Uribe AA, Baig MN, Puente EG, Viloria A, Mendel E, Bergese SD. Current intraoperative devices to reduce visual loss after spine surgery. Neurosurg Focus. 2012 Aug;33(2):E14. doi: 10.3171/2009.8.FOCUS09151.
American Society of Anesthesiologists Task Force on Perioperative Visual Loss. Practice advisory for perioperative visual loss associated with spine surgery: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Visual Loss. Anesthesiology. 2012 Feb;116(2):274-85. doi: 10.1097/ALN.0b013e31823c104d. No abstract available.
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.
Warner MA. Postoperative visual loss: experts, data, and practice. Anesthesiology. 2006 Oct;105(4):641-2. doi: 10.1097/00000542-200610000-00002. No abstract available.
Grant GP, Szirth BC, Bennett HL, Huang SS, Thaker RS, Heary RF, Turbin RE. Effects of prone and reverse trendelenburg positioning on ocular parameters. Anesthesiology. 2010 Jan;112(1):57-65. doi: 10.1097/ALN.0b013e3181c294e1.
Lee LA, Roth S, Posner KL, Cheney FW, Caplan RA, Newman NJ, Domino KB. The American Society of Anesthesiologists Postoperative Visual Loss Registry: analysis of 93 spine surgery cases with postoperative visual loss. Anesthesiology. 2006 Oct;105(4):652-9; quiz 867-8. doi: 10.1097/00000542-200610000-00007.
Lee LA. Perioperative visual loss and anesthetic management. Curr Opin Anaesthesiol. 2013 Jun;26(3):375-81. doi: 10.1097/ACO.0b013e328360dcd9.
Li A, Swinney C, Veeravagu A, Bhatti I, Ratliff J. Postoperative Visual Loss Following Lumbar Spine Surgery: A Review of Risk Factors by Diagnosis. World Neurosurg. 2015 Dec;84(6):2010-21. doi: 10.1016/j.wneu.2015.08.030. Epub 2015 Sep 1.
Nandyala SV, Marquez-Lara A, Fineberg SJ, Singh R, Singh K. Incidence and risk factors for perioperative visual loss after spinal fusion. Spine J. 2014 Sep 1;14(9):1866-72. doi: 10.1016/j.spinee.2013.10.026. Epub 2013 Nov 8.
Roth S. Perioperative visual loss: what do we know, what can we do? Br J Anaesth. 2009 Dec;103 Suppl 1(Suppl 1):i31-40. doi: 10.1093/bja/aep295.
Farag E, Sessler DI, Kovaci B, Wang L, Mascha EJ, Bell G, Kalfas I, Rockwood E, Kurz A. Effects of crystalloid versus colloid and the alpha-2 agonist brimonidine versus placebo on intraocular pressure during prone spine surgery: a factorial randomized trial. Anesthesiology. 2012 Apr;116(4):807-15. doi: 10.1097/ALN.0b013e3182475c10.
Yang XY, Wei MM, Tan H, Wang HL, Luo MQ, Xu M, Wang YW. The effect of restrictive vs. liberal fluid protocols on ocular parameters in patients undergoing prone spine surgery: a randomized controlled trial. Perioper Med (Lond). 2023 Jun 12;12(1):23. doi: 10.1186/s13741-023-00310-6.
Other Identifiers
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FOCUS
Identifier Type: -
Identifier Source: org_study_id