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

Study Overview
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Brief Summary
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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.

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

Conditions
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Influence of Perioperative Fluid Regime on Intraocular Pressure During Laparoscopic Gynecologic Surgery

Intervention / Treatment
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* Drug: ringer lactate solution
* Other: restrictive fluid regime


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: liberal fluid group<br>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. | Drug: ringer lactate solution<br> <br> |
| Active Comparator: restrictive fluid group<br>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. | Other: restrictive fluid regime<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraocular pressure, perioperative fluid, trendelenburg position, laparoscopic gynecologic surgery