We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Ziv Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01676064
First Posted: August 30, 2012
Last Update Posted: August 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ziv Hospital
August 12, 2012
August 30, 2012
August 30, 2012
August 2012
August 2013   (Final data collection date for primary outcome measure)
  • measurements of intraocular pressure during laparoscopic gynecologic surgery a sa function of diffrent perioperative fluid regimes. [ Time Frame: 24 hr ]
  • 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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Influence of Perioperative Fluid Management on Intraocular Pressure During Hynecologic Laparoscopic Pelvic Surgery
Influence of Perioperative Fluid Management on Intraocular Pressure During Hynecologic Laparoscopic Pelvic Surgery
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Influence of Perioperative Fluid Regime on Intraocular Pressure During Laparoscopic Gynecologic Surgery
  • Drug: ringer lactate solution
  • Other: restrictive fluid regime
  • 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.
    Intervention: 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.

    Intervention: Other: restrictive fluid regime
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
Not Provided
August 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01676064
0003-12-ZIV
Yes
Not Provided
Not Provided
Ziv Hospital
Ziv Hospital
Not Provided
Not Provided
Ziv Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP