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Completed

NCT Number: NCT03890510

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

About this study

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%).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ringer's Lactate solution

Other

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 position

Procedure

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

Primary outcomes

  1. 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

  1. The change of the optic sheath diameter

    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).

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

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 26, 2019
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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