Clinical trial NCT03890510: The Effect of High vs. Low Fluid Volume on Ocular Parameters in Prone Spine Surgery
Official title: Effect of Different Fluid Volume on Ocular Parameters in Patients Undergoing Spine Surgery in Prone Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prone Position
Blood Volume
Intraocular Pressure
Keywords: pulse pressure variation
intraocular pressure
optic sheath diameter
spine surgery
prone position
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly assigned to the limited fluid infusion group and the loose fluid infusion group.
Primary purpose: PREVENTION

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%).

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

Primary outcomes:
measure: The change of intraocular pressure
timeFrame: 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:
measure: The change of the optic sheath diameter
timeFrame: 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).
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Xiaoyu Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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