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

December 14, 2020 updated by: Xiao-Yu Yang, MD, Huashan Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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%).

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Investigators

  • Principal Investigator: Xiaoyu Yang, M.D., Huashan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

September 7, 2020

Study Registration Dates

First Submitted

February 21, 2019

First Submitted That Met QC Criteria

March 24, 2019

First Posted (Actual)

March 26, 2019

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 14, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOCUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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