Postoperative NauseaNCT03142464
Intravenous Fluids After Laparoscopic Cholecystectomy
A study testing Suspension of the IV fluids in people with Postoperative Nausea and Postoperative Vomiting, run by Federal University of Minas Gerais.
Trial summary
Perioperative intravenous fluid (IV) administration has been the standard procedure since 1832 and, is a widely used practice sometimes under inadequate criteria. The present work aims at verifying the clinical need that justifies the common IV fluid prescription on the postoperative (PO) period in patients undergoing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea, Postoperative Vomiting, Renal Function Abnormal
- What is being tested?
- Suspension of the IV fluids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 30 Jul 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Elective laparoscopy cholescitectomy; no intraoperative complication -
Exclusion Criteria: Co-existing severe renal failure, cardiac failure or pulmonary disease
-
About this study
Official title: Intravenous Fluids After Laparoscopic Cholecystectomy: Necessary or Dispensable. A Randomized Clinical Trial
Perioperative intravenous fluid (IV) administration has been the standard procedure since 1832 and, is a widely used practice sometimes under inadequate criteria. The present work aims at verifying the clinical need that justifies the common IV fluid prescription on the postoperative (PO) period in patients undergoing videolaparoscopic cholecystectomy (CVL) elective.
Read the detailed description
Patients undergoing elective laparoscopy cholecystectomies were randomized to either routine practice fluid prescription (control group) or no IV fluids in the postoperative period. Thirst, hunger, presence of nausea and vomiting, renal function and personal satisfaction were assessed.
Body composition was evaluated by bioimpedance
- Conditions
- Postoperative Nausea, Postoperative Vomiting, Renal Function Abnormal, Hunger, Thirst, Fluid Electrolyte Disorders
- Being tested
- Suspension of the IV fluids
- Keywords
- saline solution, laparoscopy, cholecystectomy, outcomes
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suspension of the IV fluidsOther
No IV fluids prescription, IV catheter filled with saline solution
| Study group | Role | What they receive |
|---|---|---|
| IV fluids | No intervention | Regular IV fluids (Glucose 5% and Sodium Chloride 10% or Ringer) at the surgeon description |
| No IV fluids | Experimental | No IV fluids after the termination of the operation. T Receives: Other: Suspension of the IV fluids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function
Serum creatinine
Measured: 24 hours
Secondary outcomes (3)
Presence of thirst
Visual analog scale
Measured: 24 hours
Presence of nausea
Visual analog scale
Measured: 24 hours
Total intravenous prescribed fluids per body weight
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start1 Jul 2015
- Primary completion30 Jul 2016
- Study completion30 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative NauseaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controls - convention postoperative IV fluids; intervention arm - no IV fluids postoperative
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142464
- Sponsor's protocol ID
- 102908/2015
- Status last verified
- May 2017
- First submitted
- 9 Apr 2017
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Fluids After Laparoscopic Cholecystectomy: Necessary or Dispensable. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03142464
- Acronym / sponsor ID
- 102908/2015
- Conditions
- Postoperative Nausea, Postoperative Vomiting, Renal Function Abnormal, Hunger, Thirst, Fluid Electrolyte Disorders
- Keywords
- saline solution, laparoscopy, cholecystectomy, outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 30 Jul 2016 (actual)
- Study completion
- 30 Jul 2016 (actual)
- First posted
- 5 May 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.
Perioperative intravenous fluid (IV) administration has been the standard procedure since 1832 and, is a widely used practice sometimes under inadequate criteria. The present work aims at verifying the clinical need that justifies the common IV fluid prescription on the postoperative (PO) period in patients undergoing videolaparoscopic cholecystectomy (CVL) elective.
Detailed description
Patients undergoing elective laparoscopy cholecystectomies were randomized to either routine practice fluid prescription (control group) or no IV fluids in the postoperative period. Thirst, hunger, presence of nausea and vomiting, renal function and personal satisfaction were assessed.
Body composition was evaluated by bioimpedance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Controls - convention postoperative IV fluids; intervention arm - no IV fluids postoperative
| Arm | Type | Receives |
|---|---|---|
| IV fluids | No intervention | –Regular IV fluids (Glucose 5% and Sodium Chloride 10% or Ringer) at the surgeon description |
| No IV fluids | Experimental | Other: Suspension of the IV fluidsNo IV fluids after the termination of the operation. T |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Suspension of the IV fluidsNo IV fluids prescription, IV catheter filled with saline solution | Other | No IV fluids |
Primary outcome
Renal function
Time frame: 24 hours
Serum creatinine
3 secondary outcomes
Presence of thirst
Time frame: 24 hours
Presence of nausea
Time frame: 24 hours
Total intravenous prescribed fluids per body weight
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Individual participant dataSharing planned: No
Related trials for Postoperative Nausea
Not yet recruiting
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Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
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Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Suspension of the IV fluids in people with Postoperative Nausea and Postoperative Vomiting, run by Federal University of Minas Gerais.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Renal function (time frame: 24 hours). 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 8 May 2017.