An interventional study of Ringer's Lactate solution and Spine surgery under general Anesthesia in the prone position in Prone Position, Blood Volume and Intraocular Pressure, sponsored by Huashan Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by Huashan Hospital · Not applicable, Interventional, and Prevention
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%).
Huashan Hospital is the lead sponsor of 239 studies on the registry; 102 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Procedure: 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.
Other: Ringer's Lactate solution · Procedure: Spine surgery under general Anesthesia in the prone position
Patients in both groups will receive Ringer's lactate solution continuously during operation with different infusion volume.
The surgery, general anesthesia, and the placement of the prone position will be performed according to the standard procedures.
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).
The change of the optic sheath diameter
The optic sheath diameter will be measured with a Sonocite Portable Ultrasonic System EDGE.
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).
Plan to share: No
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Huashan Hospital