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

Not Applicable

Completed

• Conditions: Prone Position; Blood Volume; Intraocular Pressure
• Interventions: Other: Ringer's Lactate solution; Procedure: Spine surgery under general Anesthesia in the prone position

• Registration Number: NCT03890510
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-03-24
• Study First Posted: 2019-03-26
• Study Start: 2019-05-01
• Primary Completion: 2020-08-31
• Study Completion: 2020-09-07
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High PPV Group	Ringer's Lactate solution	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.
Low PPV Group	Ringer's Lactate solution	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.
Low PPV Group	Spine surgery under general Anesthesia in the prone position	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.
High PPV Group	Spine surgery under general Anesthesia in the prone position	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.

Primary Outcome Measures

Name	Time	Method
The change of intraocular pressure	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

Name	Time	Method
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).	The optic sheath diameter will be measured with a Sonocite Portable Ultrasonic System EDGE.

Trial Locations

Locations (1)

Huashan Hospital Fudan University; 🇨🇳 Shanghai, Shanghai, China