The Effect of High vs. Low Fluid Volume on Ocular Parameters in Prone Spine Surgery

NCT03890510 | Completed DMC

• 1 other identifier: FOCUS
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to compare the effect of different fluid volume infusion on ocular parameters in patients undergoing spine surgery in prone position.

Conditions

Prone Position; Blood Volume; Intraocular Pressure

Keywords

pulse pressure variation; intraocular pressure; optic sheath diameter; spine surgery; prone position

Outcome Measures

Primary Outcomes (1)

• The change of intraocular pressure

  Intraocular pressure will be measured with a TONO-PEN AVIA handheld tonometer.

  10min after anesthesia induction（supine1）, 10min after prone position(prone1), 1 hour after the prone position(prone2), 2 hour after the prone position(prone3),at the end of the surgery(prone4), and 10min after return to the supine position(supine2).

Secondary Outcomes (1)

• The change of the optic sheath diameter

  10min after anesthesia induction（supine1）, 10min after prone position(prone1), 1 hour after the prone position(prone2), 2 hour after the prone position(prone3),at the end of the surgery(prone4), and 10min after return to the supine position(supine2).

Study Arms (2)

Low PPV Group

ACTIVE COMPARATOR

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.

Other: Ringer's Lactate solution; Procedure: Spine surgery under general Anesthesia in the prone position

High PPV Group

ACTIVE COMPARATOR

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.

Other: Ringer's Lactate solution; Procedure: Spine surgery under general Anesthesia in the prone position

Interventions

Ringer's Lactate solution OTHER

Patients in both groups will receive Ringer's lactate solution continuously during operation with different infusion volume.

High PPV Group; Low PPV Group

Spine surgery under general Anesthesia in the prone position PROCEDURE

The surgery, general anesthesia, and the placement of the prone position will be performed according to the standard procedures.

High PPV Group; Low PPV Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Scheduled for elective spine surgery in prone position under general anesthesia
• American Society of Anesthesiologists (ASA) physical status I or II
• Have signed consent form

You may not qualify if:

• History of eye disease or eye surgery
• 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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (13)

• 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.

  PMID: 11748391 BACKGROUND

• 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.

  PMID: 22853832 BACKGROUND

• 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.

  PMID: 22227790 BACKGROUND

• 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.

  PMID: 28284189 BACKGROUND

• 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.

  PMID: 17006056 BACKGROUND

• 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.

  PMID: 19996956 BACKGROUND

• 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.

  PMID: 17006060 BACKGROUND

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

  PMID: 23614957 BACKGROUND

• 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.

  PMID: 26341434 BACKGROUND

• 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.

  PMID: 24216394 BACKGROUND

• 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.

  PMID: 20007988 BACKGROUND

• 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.

  PMID: 22322966 RESULT

• 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.

  PMID: 37308905 DERIVED

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Xiaoyu Yang, M.D.

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomly assigned to the limited fluid infusion group and the loose fluid infusion group.

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: March 26, 2019
• Study Start: May 1, 2019
• Primary Completion: August 31, 2020
• Study Completion: September 7, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)