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

Sponsor
Huashan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03890510
Collaborator
(none)
97
1
2
16.3
6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Ringer's Lactate solution
  • Procedure: Spine surgery under general Anesthesia in the prone position
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
97 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients will be randomly assigned to the limited fluid infusion group and the loose fluid infusion group.Patients will be randomly assigned to the limited fluid infusion group and the loose fluid infusion group.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Different Fluid Volume on Ocular Parameters in Patients Undergoing Spine Surgery in Prone Position
Actual Study Start Date :
May 1, 2019
Actual Primary Completion Date :
Aug 31, 2020
Actual Study Completion Date :
Sep 7, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Huashan Hospital Fudan University Shanghai Shanghai China 200040

Sponsors and Collaborators

  • Huashan Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Xiao-Yu Yang, MD, Principal Investigator, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT03890510
Other Study ID Numbers:
  • FOCUS
First Posted:
Mar 26, 2019
Last Update Posted:
Dec 17, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xiao-Yu Yang, MD, Principal Investigator, Huashan Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 17, 2020