Anesthesia, GeneralMIFASNCT03193320
Management of Intraoperative Fluids in Ambulatory Surgery
A study testing Fluid therapy protocol in people with Anesthesia, General and Fluid Therapy, run by Policlinica Metropolitana at 1 site in Venezuela.
Trial summary
This is a single-center prospective randomized control trial (RCT) to determine whether the continuous monitoring of the plethysmographic variability index (PVI) during low-risk surgeries, can be used to optimize the intraoperative fluid administration. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, General, Fluid Therapy, Ambulatory Surgical Procedures
- What is being tested?
- Fluid therapy protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 1 siteVenezuela
- Study dates
- 1 Dec 2020to 1 Dec 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participants attending the unit for a day surgery procedure
- participants whose surgeries will be performed under general anesthesia
- aged between 18-65 years
- no abnormal findings on chest x-ray or electrocardiogram on preoperative evaluation
- patients undergoing procedures which do not require opening of the abdominal or thoracic cavities
Who cannot join
- ASA score III or higher
- patients undergoing surgeries which require additional pain management procedures (e.g. selective nerve blockade, epidural anesthesia, etc.)
- known pregnant women
- known kidney disease (or serum creatinine >1.8 mg/dl)
- known liver disease (or AST/ALT >60 U/l)
- known chronic heart failure (determined by a LVEF <55%)
Show all 9Show fewer
- participants who develop hypotension intraoperatively and do not respond to 4 fluid challenges (1000 ml), requiring aggressive fluid resuscitation OR vasopressors
- estimated blood loss during surgery >250 ml
- development of an adverse reaction to any of the drugs administered during surgery (requiring additional medical management)
Trial locations and contacts
1 site in 1 country.
Venezuela1 site
Policlinica Metropolitana
Caracas, Miranda, 01061
Telephone central, +582129080100
Pascual M Carucci, MD
About this study
Official title: Intraoperative Fluid Therapy Management in Low-risk Patients Under General Anesthesia- a Randomized Controlled Trial Comparing Liberal, Restrictive and Pleth Variability Index (PVI)-Guided Fluid Administration in a Day Surgery Setting
This is a single-center prospective randomized control trial (RCT) to determine whether the continuous monitoring of the plethysmographic variability index (PVI) during low-risk surgeries, can be used to optimize the intraoperative fluid administration. Low-risk patients that attend our day surgery unit, and who will be operated under general anesthesia, will be randomized to either a liberal fluid group, a restrictive fluid group or a dynamic monitoring group (PVI-directed). The amount of fluid infused together with the time to discharge, will be assessed in each participant during the postoperative period along with additional secondary outcomes.
- Being tested
- Fluid therapy protocol
- Keywords
- plethysmographic variability index, PVI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid therapy protocolOther
Only ringer lactate (RL solution will be used). 1. Fluid loading at induction with 500 ml of ringer lactate solution will be given to some groups. 2. Base infusion rate varies according to group. 3. Fluid challenges - infusion of 250 ml over 5 min, a hemodynamic parameter specific to each group will be monitored for 10 min after the end of infusion to look for changes. Patients who do not respond to four (4) fluid challenges (volume infused 1000 ml) will be excluded.
| Study group | Role | What they receive |
|---|---|---|
| Liberal group protocol | Active comparator | Fluid loading with 500 ml at induction. Baseline fluid infusion - 8 ml/kg/h. Fluid challenge - if mean arterial pressure (MAP) falls to < 65 mmHg, a fluid challenge will be administered. Receives: Other: Fluid therapy protocol |
| Restrictive group protocol | Active comparator | No fluid loading at induction. Baseline fluid infusion - 4 ml/kg/h. Fluid challenges - if mean arterial pressure (MAP) falls to < 65 mmHg, a fluid challenge will be administered. Receives: Other: Fluid therapy protocol |
| PVI-guided group protocol | Experimental | No fluid loading at induction. Baseline fluid infusion - 2 ml/kg/h. PVI will be monitored continuously since anesthesia induction. Fluid challenges - if PVI rises >=13 (or MAP falls < 65 mmHg), a fluid challenge will be administered. Receives: Other: Fluid therapy protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volume of fluid infused intraoperatively
Total volume of ringer lactate solution infused intraoperatively to participants (ml).
Measured: 0 min after extubation
Time to discharge
Time in hours (h) from anesthesia reversal to fulfillment of patient discharge criteria. Patients will be assessed by an attending nurse every 30 min to assess the fulfillment of these criteria.
Measured: 240 min after extubation (discharge)
Secondary outcomes (4)
Significant postoperative nausea and vomiting (PONV)
Presence of significant PONV as determined by a score ≥5 on the scale proposed by Myles SA et al. (BJA 2012)
Measured: 240 min after extubation (discharge)
Postoperative dizziness
Presence of patient self-reported dizziness in the post-operative period.
Measured: 30 min after reversal
Postoperative fatigue
Presence of patient self-reported fatigue after surgery.
Measured: 30 min after reversal
Postoperative thirst
Presence of patient self-reported thirst after surgery
Measured: 30 min after reversal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, GeneralStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 243 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinica Metropolitana
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Renzo Di Natale, Policlinica Metropolitana
- Investigators
- Pascual M Carucci, MD, Study director, Policlinica Metropolitana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193320
- Sponsor's protocol ID
- 1701
- Acronym
- MIFAS
- Status last verified
- Mar 2020
- First submitted
- 15 Jun 2017
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Fluid Therapy Management in Low-risk Patients Under General Anesthesia- a Randomized Controlled Trial Comparing Liberal, Restrictive and Pleth Variability Index (PVI)-Guided Fluid Administration in a Day Surgery Setting
- ClinicalTrials.gov ID
- NCT03193320
- Acronym / sponsor ID
- MIFAS / 1701
- Keywords
- plethysmographic variability index, PVI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 243 participants (estimated)
- Lead sponsor
- Policlinica MetropolitanaIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 20 Jun 2017 (actual)
- 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.
This is a single-center prospective randomized control trial (RCT) to determine whether the continuous monitoring of the plethysmographic variability index (PVI) during low-risk surgeries, can be used to optimize the intraoperative fluid administration. Low-risk patients that attend our day surgery unit, and who will be operated under general anesthesia, will be randomized to either a liberal fluid group, a restrictive fluid group or a dynamic monitoring group (PVI-directed). The amount of fluid infused together with the time to discharge, will be assessed in each participant during the postoperative period along with additional secondary outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liberal group protocol | Active comparator | Other: Fluid therapy protocolFluid loading with 500 ml at induction. Baseline fluid infusion - 8 ml/kg/h. Fluid challenge - if mean arterial pressure (MAP) falls to < 65 mmHg, a fluid challenge will be administered. |
| Restrictive group protocol | Active comparator | Other: Fluid therapy protocolNo fluid loading at induction. Baseline fluid infusion - 4 ml/kg/h. Fluid challenges - if mean arterial pressure (MAP) falls to < 65 mmHg, a fluid challenge will be administered. |
| PVI-guided group protocol | Experimental | Other: Fluid therapy protocolNo fluid loading at induction. Baseline fluid infusion - 2 ml/kg/h. PVI will be monitored continuously since anesthesia induction. Fluid challenges - if PVI rises >=13 (or MAP falls < 65 mmHg), a fluid challenge will be administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- participants attending the unit for a day surgery procedure
- participants whose surgeries will be performed under general anesthesia
- aged between 18-65 years
- no abnormal findings on chest x-ray or electrocardiogram on preoperative evaluation
- patients undergoing procedures which do not require opening of the abdominal or thoracic cavities
Key exclusion criteria (9 listed)
- ASA score III or higher
- patients undergoing surgeries which require additional pain management procedures (e.g. selective nerve blockade, epidural anesthesia, etc.)
- known pregnant women
- known kidney disease (or serum creatinine >1.8 mg/dl)
- known liver disease (or AST/ALT >60 U/l)
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 |
|---|---|---|
| Fluid therapy protocolOnly ringer lactate (RL solution will be used). 1. Fluid loading at induction with 500 ml of ringer lactate solution will be given to some groups. 2. Base infusion rate varies according to group. 3. Fluid challenges - infusion of 250 ml over 5 min, a hemodynamic parameter specific to each group will be monitored for 10 min after the end of infusion to look for changes. Patients who do not respond to four (4) fluid challenges (volume infused 1000 ml) will be excluded. | Other | Liberal group protocol, PVI-guided group protocol, Restrictive group protocol |
Primary outcome
Total volume of fluid infused intraoperatively
Time frame: 0 min after extubation
Total volume of ringer lactate solution infused intraoperatively to participants (ml).
Time to discharge
Time frame: 240 min after extubation (discharge)
Time in hours (h) from anesthesia reversal to fulfillment of patient discharge criteria. Patients will be assessed by an attending nurse every 30 min to assess the fulfillment of these criteria.
4 secondary outcomes
Significant postoperative nausea and vomiting (PONV)
Time frame: 240 min after extubation (discharge)
Postoperative dizziness
Time frame: 30 min after reversal
Postoperative fatigue
Time frame: 30 min after reversal
Postoperative thirst
Time frame: 30 min after reversal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Anesthesia, General
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
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.
Pascual M Carucci, MD study director
Policlinica Metropolitana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid therapy protocol in people with Anesthesia, General and Fluid Therapy, run by Policlinica Metropolitana at 1 site in Venezuela.
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 5 inclusion and 9 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 3 Mar 2020. 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 Venezuela. 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?
Contact Renzo G Di Natale, MD (+584122715908, renzogdg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total volume of fluid infused intraoperatively (time frame: 0 min after extubation). 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 3 Mar 2020.