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

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

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01676064
• Other study ID #: 0003-12-ZIV
• Status: Not yet recruiting
• Phase: N/A
• First received: August 12, 2012
• Last updated: August 27, 2012
• Start date: August 2012

Study information

• Verified date: August 2012
• Source: Ziv Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Drug:
• ringer lactate solution

Other:
• restrictive fluid regime

Locations

Country	Name	City	State
Israel	Sieff Medical Center	Zafed

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurements of intraocular pressure during laparoscopic gynecologic surgery a sa function of diffrent perioperative fluid regimes.		24 hr	Yes
Primary	IOP will be measured using a Tono-pen® XL by an ophthalmologist who will be unaware of the perioperative fluid administration regimen.		24 hr	Yes