Influence of Perioperative Fluid Management on Intraocular Pressure During Hynecologic Laparoscopic Pelvic Surgery

Not Applicable

• Conditions: Influence of Perioperative Fluid Regime on Intraocular Pressure During Laparoscopic Gynecologic Surgery
• Interventions: Drug: ringer lactate solution; Other: restrictive fluid regime

• Registration Number: NCT01676064
• Lead Sponsor: Ziv Hospital

Brief Summary

The aim of this study was to quantify the Intraocular Pressure (IOP) changes in patients undergoing laparoscopic hysterectomy at different time points and body positions throughout the procedure, and to explore the influence of perioperative fluid management on the fluctuations of IOP during perioperative period.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-08
• Study Start: 2012-08
• Study First Submitted: 2012-08-12
• Study First Submitted QC: 2012-08-27
• Last Update Submitted: 2012-08-27
• Study First Posted: 2012-08-30
• Last Update Posted: 2012-08-30
• Primary Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• 50-60 adult female patients,
• ASA physical status I or II,
• scheduled for elective hynecologic laparoscopic pelvic surgery will be included in the study.

Exclusion Criteria

• patients will be excluded if they are > 70 and < 18 yr of age,
• had have a body weight > 150% of their ideal body weight,
• have acute or chronic eye disease,
• receive any medication known to alter IOP, or
• have any mental illnesses.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
liberal fluid group	ringer lactate solution	during surgery 7 ml/kg/hr RL during first intraoperative hr, 5 ml/kg/hr for the subsequent hours.After surgery ( PACU) 1,5 ml/kg/hr;After operation ward on the day of surgery 1,5 ml/kg/hr; Postoperative day 1- 1,5 ml/kg/hr RL, oral fluids;Postoperative day 2-oral fluids and solid food according to surgical allowance.
restrictive fluid group	restrictive fluid regime	during surgery-RL according to "4-2-1" 4 ml/kg/hr for first 10 kg (=40ml/hr) then 2 ml/kg/hr for next 10 kg (=20ml/hr)then 1 ml/kg/hr for any kg over 20 kg of weight. This always gives 60ml/hr for first 20 kg then you add 1 ml/kg/hr for each kg over 20 kg. After surgery (PACU):"4-2-1" rule. After operation ward on the day of surgery 1,5 ml/kg/hr.Postoperative day 1:1,5 ml/kg/hr RL, oral fluids. Postoperative day 2:oral fluids and solid food according to surgical allowance.

Primary Outcome Measures

Name	Time	Method
measurements of intraocular pressure during laparoscopic gynecologic surgery a sa function of diffrent perioperative fluid regimes.	24 hr
IOP will be measured using a Tono-pen® XL by an ophthalmologist who will be unaware of the perioperative fluid administration regimen.	24 hr

Trial Locations

Locations (1)

Sieff Medical Center; 🇮🇱 Zafed, Israel