Nausea and Vomiting, PostoperativePhase 1NCT01301404
10% Carbohydrate Drink for Preventing Post-operative Nausea and Vomiting (PONV) After Spinal Morphine
A Phase 1 study testing 10% carbohydrate drink in people with Nausea and Vomiting, Postoperative, run by Mahidol University at 1 site in Thailand.
Trial summary
PONV after intrathecal morphine, occurs up to 30-40 percent. The patients having TKR normally are female, obese and non-smoker which are risk factors for PONV. Recently, a multimodal approach, combining several means to minimize PONV, has found wide acceptance as a standard of care. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Nausea and Vomiting, Postoperative
- What is being tested?
- 10% carbohydrate drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2011to Jun 2012
- Phase
- Phase 1
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are under going unilateral TKR, with ASA I-III who scheduled started in the morning list (before noon)
Who cannot join
- Diabetes
- History of motion sickness
- Chronic kidney disease (CKD, creatinine > 2 mg/dl)
- Hiatus hernia or gastro esophageal reflux
- Patients receiving drugs that might affect GI motility such as opioids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Rehydration Therapy With 10% Carbohydrate Drink for Preventing Postoperative Nausea and Vomiting (PONV) After Low Dose of Spinal Morphine in Patients Undergoing Total Knee Replacement
PONV after intrathecal morphine, occurs up to 30-40 percent. The patients having TKR normally are female, obese and non-smoker which are risk factors for PONV. Recently, a multimodal approach, combining several means to minimize PONV, has found wide acceptance as a standard of care. In our hospital, most of the patients are supposed to fast after midnight The oral rehydration therapy reduce patients thirst and increase his satisfaction, but whether or not this method can reduce the incidence of PONV after low dose (0.2 mg) intrathecal morphine is not investigated yet. The aim of this study is to investigate the effect of preoperative oral rehydration therapy on the incidence of PONV.
Read the detailed description
We enroll patients who are undergoing TKR under spinal anesthesia with 0.5% heavy bupivacaine 10-15 mg (2.0-3.0 ml)+ intrathecal morphine 0.2 mg+ femoral nerve block with 0.25% bupivacaine 20 ml.
The enrolled patients will fast after midnight and in the morning they are allowed to drink 10% carbohydrate drink or not to drink (according to their randomization). 400 ml of 10% carbohydrate drink is drunk between evening and midnight and extra water if needed in the study group. In the control group, the patients are allowed to drink until midnight. Total of water consumption between 18.00-24.00 will be recorded in both groups. In the morning, the study group will drink another 400 ml of 10% carbohydrate drink between 6 - 7 am. The premedications should not include sedation or GI mobility drugs. Before starting anesthesia, the patients will be asked some questions about thirsty, hungry, anxiety and nausea and weigh their feeling from 0-10.
The surgery and pain therapy will be tha same in both groups and the PONV (incidence, severity and rescue therapy) at recovery room and 24 hours postoperative period will be recorded.
- Conditions
- Nausea and Vomiting, Postoperative
- Being tested
- 10% carbohydrate drink
- Keywords
- Postoperative nausea and vomiting (PONV), Spinal morphine, Total knee replacement (TKR), blood sugar, carbohydrate drink
- 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.
10% carbohydrate drinkDietary supplement
Also called Green mate (orange favor)
In the study group, 10% carbohydrate drink 400 ml will be given between 18-24 hr the night before surgery and another 400 ml will be drunk at 6-7 hr in the morning of surgery.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | patient receive nothing |
| carbohydrate drink | Experimental | 10%carbohydrate drink Receives: Dietary Supplement: 10% carbohydrate drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative nausea and vomiting after TKR
Compare the incidence, severity and rescue therapy of PONV in control (fast)group a group and the study (carbohydrate drink) group
Measured: 24 hours
Secondary outcomes (1)
Incidence of hyperglycemia during perioperative period
Regarding to the perioperative stress and carbohydrate drinking, we also measure blood sugar before and postoperation and compare their values between groups
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 posted23 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and Vomiting, PostoperativeStudies of the same condition, open and under way.
- More trials run by Mahidol 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manee Raksakietisak, Mahidol University
- Investigators
- Manee Raksakietisak, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301404
- Sponsor's protocol ID
- 763/2553(EC2)
- Status last verified
- Jun 2012
- First submitted
- 20 Feb 2011
- Last updated
- 19 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Rehydration Therapy With 10% Carbohydrate Drink for Preventing Postoperative Nausea and Vomiting (PONV) After Low Dose of Spinal Morphine in Patients Undergoing Total Knee Replacement
- ClinicalTrials.gov ID
- NCT01301404
- Acronym / sponsor ID
- 763/2553(EC2)
- Conditions
- Nausea and Vomiting, Postoperative
- Keywords
- Postoperative nausea and vomiting (PONV), Spinal morphine, Total knee replacement (TKR), blood sugar, carbohydrate drink
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Feb 2011 (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.
PONV after intrathecal morphine, occurs up to 30-40 percent. The patients having TKR normally are female, obese and non-smoker which are risk factors for PONV. Recently, a multimodal approach, combining several means to minimize PONV, has found wide acceptance as a standard of care. In our hospital, most of the patients are supposed to fast after midnight The oral rehydration therapy reduce patients thirst and increase his satisfaction, but whether or not this method can reduce the incidence of PONV after low dose (0.2 mg) intrathecal morphine is not investigated yet. The aim of this study is to investigate the effect of preoperative oral rehydration therapy on the incidence of PONV.
Detailed description
We enroll patients who are undergoing TKR under spinal anesthesia with 0.5% heavy bupivacaine 10-15 mg (2.0-3.0 ml)+ intrathecal morphine 0.2 mg+ femoral nerve block with 0.25% bupivacaine 20 ml.
The enrolled patients will fast after midnight and in the morning they are allowed to drink 10% carbohydrate drink or not to drink (according to their randomization). 400 ml of 10% carbohydrate drink is drunk between evening and midnight and extra water if needed in the study group. In the control group, the patients are allowed to drink until midnight. Total of water consumption between 18.00-24.00 will be recorded in both groups. In the morning, the study group will drink another 400 ml of 10% carbohydrate drink between 6 - 7 am. The premedications should not include sedation or GI mobility drugs. Before starting anesthesia, the patients will be asked some questions about thirsty, hungry, anxiety and nausea and weigh their feeling from 0-10.
The surgery and pain therapy will be tha same in both groups and the PONV (incidence, severity and rescue therapy) at recovery room and 24 hours postoperative period will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –patient receive nothing |
| carbohydrate drink | Experimental | Dietary Supplement: 10% carbohydrate drink10%carbohydrate drink |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients are under going unilateral TKR, with ASA I-III who scheduled started in the morning list (before noon)
Key exclusion criteria (5 listed)
- Diabetes
- History of motion sickness
- Chronic kidney disease (CKD, creatinine > 2 mg/dl)
- Hiatus hernia or gastro esophageal reflux
- Patients receiving drugs that might affect GI motility such as opioids
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 |
|---|---|---|
| 10% carbohydrate drinkAlso: Green mate (orange favor)In the study group, 10% carbohydrate drink 400 ml will be given between 18-24 hr the night before surgery and another 400 ml will be drunk at 6-7 hr in the morning of surgery. | Dietary supplement | carbohydrate drink |
Primary outcome
The incidence of postoperative nausea and vomiting after TKR
Time frame: 24 hours
Compare the incidence, severity and rescue therapy of PONV in control (fast)group a group and the study (carbohydrate drink) group
1 secondary outcome
Incidence of hyperglycemia during perioperative period
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 19 Jul 2013.
Related trials for Nausea and Vomiting, Postoperative
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Not yet recruitingPhase 4
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
Postoperative Vomiting, Postoperative Nausea and Vomiting
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.
Manee Raksakietisak, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 10% carbohydrate drink in people with Nausea and Vomiting, Postoperative, run by Mahidol University at 1 site in Thailand.
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 1 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: finished, as of the sponsor's last update on 19 Jul 2013. 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 Thailand. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The incidence of postoperative nausea and vomiting after TKR (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 19 Jul 2013.