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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890510
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Xiao-Yu Yang, MD, Huashan Hospital

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.

Condition or disease Intervention/treatment Phase
Prone Position Blood Volume Intraocular Pressure Other: Ringer's Lactate solution Procedure: Spine surgery under general Anesthesia in the prone position Not Applicable

Detailed 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%).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomly assigned to the limited fluid infusion group and the loose fluid infusion group.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Different Fluid Volume on Ocular Parameters in Patients Undergoing Spine Surgery in Prone Position
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : September 7, 2020

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Arm Intervention/treatment
Active Comparator: 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.
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.

Active Comparator: 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.
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.




Primary Outcome Measures :
  1. The change of intraocular pressure [ Time Frame: 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). ]
    Intraocular pressure will be measured with a TONO-PEN AVIA handheld tonometer.


Secondary Outcome Measures :
  1. The change of the optic sheath diameter [ Time Frame: 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). ]
    The optic sheath diameter will be measured with a Sonocite Portable Ultrasonic System EDGE.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890510


Locations
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China, Shanghai
Huashan Hospital Fudan University
Shanghai, Shanghai, China, 200040
Sponsors and Collaborators
Huashan Hospital
Investigators
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Principal Investigator: Xiaoyu Yang, M.D. Huashan Hospital
Publications of Results:
Other Publications:

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Responsible Party: Xiao-Yu Yang, MD, Principal Investigator, Huashan Hospital
ClinicalTrials.gov Identifier: NCT03890510    
Other Study ID Numbers: FOCUS
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiao-Yu Yang, MD, Huashan Hospital:
pulse pressure variation
intraocular pressure
optic sheath diameter
spine surgery
prone position
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs