Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Ziv Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01676064
First received: August 12, 2012
Last updated: August 27, 2012
Last verified: August 2012

August 12, 2012
August 27, 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01676064 on ClinicalTrials.gov Archive Site
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.
 
Not yet recruiting
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.
Female
18 Years to 70 Years
No
Israel
 
NCT01676064
0003-12-ZIV
Yes
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