Skip to main content
Clinical Trials/NCT03890510
NCT03890510
Completed
Not Applicable

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

Huashan Hospital1 site in 1 country97 target enrollmentMay 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prone Position
Sponsor
Huashan Hospital
Enrollment
97
Locations
1
Primary Endpoint
The change of intraocular pressure
Status
Completed
Last Updated
5 years ago

Overview

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.

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%).

Registry
clinicaltrials.gov
Start Date
May 1, 2019
End Date
September 7, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xiao-Yu Yang, MD

Principal Investigator

Huashan Hospital

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • 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 Sites (1)

Loading locations...

Similar Trials