Influence of Perioperative Fluid Management on Intraocular Pressure During Hynecologic Laparoscopic Pelvic Surgery
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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 |
- 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 |
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 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 May 21, 2013