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

Huashan Hospital97 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Prone Position Blood Volume Intraocular Pressure

Interventions

Ringer's Lactate solutionOTHER

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

Spine surgery under general Anesthesia in the prone positionPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

The change of intraocular pressure

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

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).

Secondary Outcomes

The change of the optic sheath diameter

The optic sheath diameter will be measured with a Sonocite Portable Ultrasonic System EDGE.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.