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

Intraocular Pressure Clinical Trial

Official title:

Effect of Different Fluid Volume on Ocular Parameters in Patients Undergoing Spine Surgery in Prone Position

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03890510
• Other study ID #: FOCUS
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: September 7, 2020

Study information

• Verified date: December 2020
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In the prone position, the intraocular pressure and optic nerve sheath diameter increase progressively with time as compared with those in the supine position. Excessive fluid infusion may further increase intraocular pressure and optic nerve sheath diameter. Pulse pressure variation (PPV) is a dynamic index which can effectively assess fluid responsiveness during general anesthesia.Therefore,the investigators have designed a study to compare the effect of different fluid volume infusion guided by low and high PPV indices on intraocular pressure and optic nerve sheath of patients undergoing prone spine surgery with general anesthesia. One group of the patients will receive relatively loose fluid infusion (target value of PPV: 6%-9%),while the other group of the patients will receive limited fluid infusion (target value of PPV: 13%-16%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: September 7, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Blood Volume
• Intraocular Pressure
• Prone Position

Intervention

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

Procedure:
• 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.

Locations

Country	Name	City	State
China	Huashan Hospital Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

References & Publications (12)

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. — View 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° Trendelenburg position. BMC Anesthesiol. 2017 Mar 11;17(1):40. doi: 10.1186/s12871-017-0333-3. — View Citation

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. — View Citation

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 a-2 agonist brimonidine versus placebo on intraocular pressure during prone spine surgery: a factorial randomized trial. — View Citation

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. — View Citation

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. — View Citation

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

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. Review. — View Citation

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. — View Citation

Roth S. Perioperative visual loss: what do we know, what can we do? Br J Anaesth. 2009 Dec;103 Suppl 1:i31-40. doi: 10.1093/bja/aep295. Review. — View Citation

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. Review. — View Citation

Warner MA. Postoperative visual loss: experts, data, and practice. Anesthesiology. 2006 Oct;105(4):641-2. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The change of the optic sheath diameter	The optic sheath diameter will be measured with a Sonocite Portable Ultrasonic System EDGE.	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).