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

NCT ID: NCT01676064

Last Updated: 2012-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

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.

Detailed Description

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Conditions

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

Keywords

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intraocular pressure perioperative fluid trendelenburg position laparoscopic gynecologic surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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liberal fluid group

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.

Group Type ACTIVE_COMPARATOR

ringer lactate solution

Intervention Type DRUG

restrictive fluid group

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.

Group Type ACTIVE_COMPARATOR

restrictive fluid regime

Intervention Type OTHER

Interventions

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ringer lactate solution

Intervention Type DRUG

restrictive fluid regime

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ziv Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sieff Medical Center

Zafed, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0003-12-ZIV

Identifier Type: -

Identifier Source: org_study_id