Influence of Perioperative Fluid Regime on Intraocular Pressure During Laparoscopic Gynecologic SurgeryNCT01676064
Influence of Perioperative Fluid Management on Intraocular Pressure During Hynecologic Laparoscopic Pelvic Surgery
A study testing ringer lactate solution and restrictive fluid regime in people with Influence of Perioperative Fluid Regime on Intraocular Pressure During Laparoscopic Gynecologic Surgery, run by Ziv Hospital at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Influence of Perioperative Fluid Regime on Intraocular Pressure During Laparoscopic Gynecologic Surgery
- What is being tested?
- ringer lactate solution and restrictive fluid regime
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50-60 adult female patients,
- ASA physical status I or II,
- scheduled for elective hynecologic laparoscopic pelvic surgery will be included in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- ringer lactate solution, restrictive fluid regime
- Keywords
- intraocular pressure, perioperative fluid, trendelenburg position, laparoscopic gynecologic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ringer lactate solutionDrug
restrictive fluid regimeOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: restrictive fluid regime |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurements of intraocular pressure during laparoscopic gynecologic surgery a sa function of diffrent perioperative fluid regimes.
Measured: 24 hr
IOP will be measured using a Tono-pen® XL by an ophthalmologist who will be unaware of the perioperative fluid administration regimen.
Measured: 24 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influence of Perioperative Fluid Regime on Intraocular Pressure During Laparoscopic Gynecologic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676064
- Sponsor's protocol ID
- 0003-12-ZIV
- Status last verified
- Aug 2012
- First submitted
- 12 Aug 2012
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Perioperative Fluid Management on Intraocular Pressure During Hynecologic Laparoscopic Pelvic Surgery
- ClinicalTrials.gov ID
- NCT01676064
- Acronym / sponsor ID
- 0003-12-ZIV
- Keywords
- intraocular pressure, perioperative fluid, trendelenburg position, laparoscopic gynecologic surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (estimated)
- First posted
- 30 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liberal fluid group | Active comparator | Drug: ringer lactate solutionduring 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. |
| restrictive fluid group | Active comparator | Other: restrictive fluid regimeduring 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 50-60 adult female patients,
- ASA physical status I or II,
- scheduled for elective hynecologic laparoscopic pelvic surgery will be included in the study.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ringer lactate solution | Drug | liberal fluid group |
| restrictive fluid regime | Other | restrictive fluid group |
Primary outcome
measurements of intraocular pressure during laparoscopic gynecologic surgery a sa function of diffrent perioperative fluid regimes.
Time frame: 24 hr
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ringer lactate solution and restrictive fluid regime in people with Influence of Perioperative Fluid Regime on Intraocular Pressure During Laparoscopic Gynecologic Surgery, run by Ziv Hospital at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurements of intraocular pressure during laparoscopic gynecologic surgery a sa function of diffrent perioperative fluid regimes. (time frame: 24 hr). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2012.