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

NCT01676064 | Unknown DMC

• 1 other identifier: 0003-12-ZIV
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

intraocular pressure; perioperative fluid; trendelenburg position; laparoscopic gynecologic surgery

Outcome Measures

Primary Outcomes (2)

• measurements of intraocular pressure during laparoscopic gynecologic surgery a sa function of diffrent perioperative fluid regimes.

  24 hr

• IOP will be measured using a Tono-pen® XL by an ophthalmologist who will be unaware of the perioperative fluid administration regimen.

  24 hr

Study Arms (2)

liberal fluid group

ACTIVE COMPARATOR

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

restrictive fluid group

ACTIVE COMPARATOR

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

Interventions

ringer lactate solution DRUG

liberal fluid group

restrictive fluid regime OTHER

restrictive fluid group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult female patients,
• ASA physical status I or II,
• scheduled for elective hynecologic laparoscopic pelvic surgery will be included in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ziv Hospital: lead

Study Sites (1)

Sieff Medical Center

Zafed, 13300, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2012
• First Posted: August 30, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2013
• Last Updated: August 30, 2012

Record last verified: 2012-08

Locations

IL (1)