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

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ClinicalTrials.gov Identifier: NCT01676064
Recruitment Status : Unknown
Verified August 2012 by Ziv Hospital.
Recruitment status was:  Not yet recruiting
First Posted : August 30, 2012
Last Update Posted : August 30, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Influence of Perioperative Fluid Regime on Intraocular Pressure During Laparoscopic Gynecologic Surgery Drug: ringer lactate solution Other: restrictive fluid regime

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Influence of Perioperative Fluid Management on Intraocular Pressure During Hynecologic Laparoscopic Pelvic Surgery
Study Start Date : August 2012
Estimated Primary Completion Date : August 2013
Arms and Interventions

Arm Intervention/treatment
Active Comparator: 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.
Drug: ringer lactate solution
Active Comparator: 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.

Other: restrictive fluid regime


Outcome Measures

Primary Outcome Measures :
  1. measurements of intraocular pressure during laparoscopic gynecologic surgery a sa function of diffrent perioperative fluid regimes. [ Time Frame: 24 hr ]
  2. IOP will be measured using a Tono-pen® XL by an ophthalmologist who will be unaware of the perioperative fluid administration regimen. [ Time Frame: 24 hr ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676064


Locations
Israel
Sieff Medical Center
Zafed, Israel, 13300
Sponsors and Collaborators
Ziv Hospital
More Information

Responsible Party: Ziv Hospital
ClinicalTrials.gov Identifier: NCT01676064     History of Changes
Other Study ID Numbers: 0003-12-ZIV
First Posted: August 30, 2012    Key Record Dates
Last Update Posted: August 30, 2012
Last Verified: August 2012

Keywords provided by Ziv Hospital:
intraocular pressure
perioperative fluid
trendelenburg position
laparoscopic gynecologic surgery