Postoperative Nausea and VomitingNCT01123837
A Closer Look at the Effect of Dextrose on Postoperative Nausea and Vomiting
A study testing Intravenous fluid and D5LR or lactated ringers in people with Postoperative Nausea and Vomiting, run by Loma Linda University at 1 site in United States.
Trial summary
"The purpose of this investigator-initiated study is to see if giving dextrose fluid in the veins (IV) decreases the risk of postoperative nausea and vomiting (PONV) in female urologic, gynecologic and breast outpatient surgery patients and at what blood surgery level. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Intravenous fluid and D5LR or lactated ringers
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Sep 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I or II
- female urologic, gynecologic and breast surgery patients undergoing scheduled same day procedures at LLUMC Heart and Surgical Hospital
Who cannot join
- age <18 or >65;
- severe hypertension,diabetes mellitus, significant hepatic or renal disease
- excessive blood loss
- sustained (>10 min)>20% from baseline drop in BP after treatment
- inability to follow protocol
- refusal to sign consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center Heart and Surgical Hospital
Loma Linda, California, 92354
About this study
"The purpose of this investigator-initiated study is to see if giving dextrose fluid in the veins (IV) decreases the risk of postoperative nausea and vomiting (PONV) in female urologic, gynecologic and breast outpatient surgery patients and at what blood surgery level. The reason for this study is that IV dextrose has been shown to decrease the incidence of PONV and the use of medications to treat PONV, while leading to sooner discharge after surgery. This can decrease overall healthcare cost and improving patient satisfaction."
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Intravenous fluid, D5LR or lactated ringers
- 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.
Intravenous fluidOther
The treatment group will receive a 250cc bolus over 2 hrs of D5LR prior to the end of surgery and continued in the PACU. Blood glucose will be checked 3 different times using an Accu-chek monitor along with the type and number of rescue medications given at 30, 60, and 120 minutes after anesthesia and the post-op morning.
The control group will receive a 250cc bolus over 2 hours of LR. Blood glucose will be monitored 3 times along with the type and how much of rescue medications are given at 30, 60 and 120 minutes post-op and the morning after surgery.
D5LR or lactated ringersOther
The purpose of the study is to see if giving dextrose fluid in the veins (IV) decreases the risk of postoperative nausea and vomiting (PONV) in female urologic, gynecologic and breast outpatient surgery patients and at what blood sugar level.
The reason for this study is that IV dextrose may decrease the incidence of PONV and the use of medications to treat PONV, while leading to sooner discharge after surgery. This can decrease overall healthcare cost and improving patient satisfaction.
| Study group | Role | What they receive |
|---|---|---|
| D5LR | Active comparator | In the treatment group, a 250cc bolus over 2 hrs of D5LR will be initiated prior to the end of surgery and continued in PACU.Blood glucose will be measured at 3 different timepoints using a point of care testing device (Accu-Chek). We will be measuring changes in blood glucose levels associated with PONV and the type and number of rescue medicines given at 30, 60, and 120 minutes after anesthesia and the first postoperative morning Receives: Other: Intravenous fluid; Other: D5LR or lactated ringers |
| lactated ringers | Active comparator | In the control group, a 250cc bolus over 2 hrs of LR will be initiated prior to the end of surgery and continued in PACU. Blood glucose will be measured at 3 different timepoints using a point of care testing device (Accu-Chek). We will be measuring changes in blood glucose levels associated with PONV and the type and number of rescue medicines given at 30, 60, and 120 minutes after anesthesia and the first postoperative morning. Receives: Other: Intravenous fluid; Other: D5LR or lactated ringers |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Closer Look at the Effect of Glucose on Postoperative Nausea and Vomiting
The primary outcome measures will be the severity and incidence of PONV along with the type and number of rescue medications given at 0,30,60, and 120 minutes PACU time and the next morning.
Measured: approximately 24 hours
Secondary outcomes (1)
A Closer Look at the Effect of Dextrose on Post-operative nausea and vomiting
Secondary endpoints recorded will be length of surgery, history of PONV, amount of pain medicine administered, blood loss, drop in BP > 20%, unplanned hospital admission for PONV, and time till ready for discharge from PACU.
Measured: approximately 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Applegate, Loma Linda University
- Investigators
- Richard L Applegate, M.D., Principal investigator, Loma Linda University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123837
- Sponsor's protocol ID
- 5100086
- Status last verified
- Jan 2014
- First submitted
- 12 May 2010
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Closer Look at the Effect of Dextrose on Postoperative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT01123837
- Acronym / sponsor ID
- 5100086
- Conditions
- Postoperative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 14 May 2010 (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 purpose of this investigator-initiated study is to see if giving dextrose fluid in the veins (IV) decreases the risk of postoperative nausea and vomiting (PONV) in female urologic, gynecologic and breast outpatient surgery patients and at what blood surgery level. The reason for this study is that IV dextrose has been shown to decrease the incidence of PONV and the use of medications to treat PONV, while leading to sooner discharge after surgery. This can decrease overall healthcare cost and improving patient satisfaction."
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D5LR | Active comparator | Other: Intravenous fluid, Other: D5LR or lactated ringersIn the treatment group, a 250cc bolus over 2 hrs of D5LR will be initiated prior to the end of surgery and continued in PACU.Blood glucose will be measured at 3 different timepoints using a point of care testing device (Accu-Chek). We will be measuring changes in blood glucose levels associated with PONV and the type and number of rescue medicines given at 30, 60, and 120 minutes after anesthesia and the first postoperative morning |
| lactated ringers | Active comparator | Other: Intravenous fluid, Other: D5LR or lactated ringersIn the control group, a 250cc bolus over 2 hrs of LR will be initiated prior to the end of surgery and continued in PACU. Blood glucose will be measured at 3 different timepoints using a point of care testing device (Accu-Chek). We will be measuring changes in blood glucose levels associated with PONV and the type and number of rescue medicines given at 30, 60, and 120 minutes after anesthesia and the first postoperative morning. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I or II
- female urologic, gynecologic and breast surgery patients undergoing scheduled same day procedures at LLUMC Heart and Surgical Hospital
Key exclusion criteria (6 listed)
- age <18 or >65;
- severe hypertension,diabetes mellitus, significant hepatic or renal disease
- excessive blood loss
- sustained (>10 min)>20% from baseline drop in BP after treatment
- inability to follow protocol
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 |
|---|---|---|
| Intravenous fluidThe treatment group will receive a 250cc bolus over 2 hrs of D5LR prior to the end of surgery and continued in the PACU. Blood glucose will be checked 3 different times using an Accu-chek monitor along with the type and number of rescue medications given at 30, 60, and 120 minutes after anesthesia and the post-op morning. The control group will receive a 250cc bolus over 2 hours of LR. Blood glucose will be monitored 3 times along with the type and how much of rescue medications are given at 30, 60 and 120 minutes post-op and the morning after surgery. | Other | D5LR, lactated ringers |
| D5LR or lactated ringersThe purpose of the study is to see if giving dextrose fluid in the veins (IV) decreases the risk of postoperative nausea and vomiting (PONV) in female urologic, gynecologic and breast outpatient surgery patients and at what blood sugar level. The reason for this study is that IV dextrose may decrease the incidence of PONV and the use of medications to treat PONV, while leading to sooner discharge after surgery. This can decrease overall healthcare cost and improving patient satisfaction. | Other | D5LR, lactated ringers |
Primary outcome
A Closer Look at the Effect of Glucose on Postoperative Nausea and Vomiting
Time frame: approximately 24 hours
The primary outcome measures will be the severity and incidence of PONV along with the type and number of rescue medications given at 0,30,60, and 120 minutes PACU time and the next morning.
1 secondary outcome
A Closer Look at the Effect of Dextrose on Post-operative nausea and vomiting
Time frame: approximately 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 22 Jan 2014.
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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.
Richard L Applegate, M.D. principal investigator
Loma Linda University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous fluid and D5LR or lactated ringers in people with Postoperative Nausea and Vomiting, run by Loma Linda University at 1 site in United States.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 22 Jan 2014. 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 United States. 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?
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?
A Closer Look at the Effect of Glucose on Postoperative Nausea and Vomiting (time frame: approximately 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 22 Jan 2014.