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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Influence of Perioperative Fluid Management on Intraocular Pressure During Hynecologic Laparoscopic Pelvic Surgery

Resource links provided by NLM:


Further study details as provided by Ziv Hospital:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01676064

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

No publications provided

Responsible Party: Ziv Hospital
ClinicalTrials.gov Identifier: NCT01676064     History of Changes
Other Study ID Numbers: 0003-12-ZIV
Study First Received: August 12, 2012
Last Updated: August 27, 2012
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on September 18, 2014