Postoperative Nausea and VomitingPhase 4NCT01449708
Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting in Bariatric Surgery
A Phase 4 study testing TIVA NoNarc in people with Postoperative Nausea and Vomiting, run by Coastal Anesthesiology Consultants at 1 site in United States.
Trial summary
Morbidly obese patients are at high risk for Postoperative Nausea and Vomiting (PONV) after surgery and general anesthesia. The results of our observational study indicate that 42.7% of patients require medication to treat PONV in the first 24 hours after bariatric surgery despite our aggressive perioperative approach… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- TIVA NoNarc
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Oct 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- All patients scheduled for bariatric surgery at Flagler Hospital will be included after written and informed consent.
Who cannot join
- Patients will be excluded from the study if they don't consent to participate in the study. Patients allergic to any of the study medication will be excluded. Patients with second or third degree heart block will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting (PONV) in Bariatric Surgery
Morbidly obese patients are at high risk for Postoperative Nausea and Vomiting (PONV) after surgery and general anesthesia. The results of our observational study indicate that 42.7% of patients require medication to treat PONV in the first 24 hours after bariatric surgery despite our aggressive perioperative approach with triple prophylaxis. Common risk factors for PONV are the use of intraoperative narcotics and anesthetic gases.
Preliminary results of multimodal postoperative analgesia in the first 24 hours lead to a reduction of narcotic consumption, desaturations and use of antiemetic medication.
Read more
Our study hypothesis is that different types of anesthetics reduce PONV further.
Patient would be randomly assigned to receive either our current intraoperative management or a narcotic free, total intravenous general anesthetic (TIVA).
The investigators hope to improve patients' satisfaction by reducing PONV in the postoperative period.
Read the detailed description
See above
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- TIVA NoNarc
- Keywords
- Bariatric Surgery, TIVA, PONV, non-opioid, OSA
- 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.
TIVA NoNarcDrug
- patients in both groups receive antiemetic prophylaxis
- patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
- postop management in both groups is similar in both groups
| Study group | Role | What they receive |
|---|---|---|
| Balanced Anesthesia | No intervention | Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. |
| NoNarc TIVA | Active comparator | Patients will receive narcotic free total intravenous anesthesia with Propofol, dexmedetomidine and ketamine Receives: Drug: TIVA NoNarc |
What is being measured
The primary outcome is the main question the study is designed to answer.
PONV During the First 24 Hours After Bariatric Surgery
Postoperative Nausea and Vomiting
Measured: 24 hours
Secondary outcomes (2)
Number of Patients Requiring Antiemetic Rescue Medication (AERM)
Measured: 24hours
PONV Between Different Surgical Procedures (Percentage of Participants)
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 posted10 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coastal Anesthesiology Consultants
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Ziemann-Gimmel, Coastal Anesthesiology Consultants
- Investigators
- Patrick Ziemann-Gimmel, MD, Principal investigator, Coastal Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449708
- Sponsor's protocol ID
- 3766 - 6886
- Status last verified
- Feb 2016
- First submitted
- 6 Oct 2011
- Last updated
- 21 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ziemann-Gimmel P, Goldfarb AA, Koppman J, Marema RT. Opioid-free total intravenous anaesthesia reduces postoperative nausea and vomiting in bariatric surgery beyond triple prophylaxis. Br J Anaesth. 2014 May;112(5):906-11. doi: 10.1093/bja/aet551. Epub 2014 Feb 18.
PubMed 24554545
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Anesthetic Management on Postoperative Nausea and Vomiting (PONV) in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01449708
- Acronym / sponsor ID
- 3766 - 6886
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Bariatric Surgery, TIVA, PONV, non-opioid, OSA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Coastal Anesthesiology ConsultantsUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 Oct 2011 (estimated)
- Results
- Posted 21 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Morbidly obese patients are at high risk for Postoperative Nausea and Vomiting (PONV) after surgery and general anesthesia. The results of our observational study indicate that 42.7% of patients require medication to treat PONV in the first 24 hours after bariatric surgery despite our aggressive perioperative approach with triple prophylaxis. Common risk factors for PONV are the use of intraoperative narcotics and anesthetic gases.
Preliminary results of multimodal postoperative analgesia in the first 24 hours lead to a reduction of narcotic consumption, desaturations and use of antiemetic medication.
Our study hypothesis is that different types of anesthetics reduce PONV further.
Patient would be randomly assigned to receive either our current intraoperative management or a narcotic free, total intravenous general anesthetic (TIVA).
The investigators hope to improve patients' satisfaction by reducing PONV in the postoperative period.
Detailed description
See above
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balanced Anesthesia | No intervention | –Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. |
| NoNarc TIVA | Active comparator | Drug: TIVA NoNarcPatients will receive narcotic free total intravenous anesthesia with Propofol, dexmedetomidine and ketamine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients scheduled for bariatric surgery at Flagler Hospital will be included after written and informed consent.
Key exclusion criteria (1 listed)
- Patients will be excluded from the study if they don't consent to participate in the study. Patients allergic to any of the study medication will be excluded. Patients with second or third degree heart block will be excluded.
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 |
|---|---|---|
| TIVA NoNarc* patients in both groups receive antiemetic prophylaxis * patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively * postop management in both groups is similar in both groups | Drug | NoNarc TIVA |
Primary outcome
PONV During the First 24 Hours After Bariatric Surgery
Time frame: 24 hours
Postoperative Nausea and Vomiting
2 secondary outcomes
Number of Patients Requiring Antiemetic Rescue Medication (AERM)
Time frame: 24hours
PONV Between Different Surgical Procedures (Percentage of Participants)
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24554545Ziemann-Gimmel P, Goldfarb AA, Koppman J, Marema RT. Opioid-free total intravenous anaesthesia reduces postoperative nausea and vomiting in bariatric surgery beyond triple prophylaxis. Br J Anaesth. 2014 May;112(5):906-11. doi: 10.1093/bja/aet551. Epub 2014 Feb 18.
- Individual participant dataSharing planned: No
Related trials for Postoperative Nausea and Vomiting
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Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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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.
Patrick Ziemann-Gimmel, MD principal investigator
Coastal Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TIVA NoNarc in people with Postoperative Nausea and Vomiting, run by Coastal Anesthesiology Consultants 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 1 inclusion and 1 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 21 Mar 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PONV During the First 24 Hours After Bariatric Surgery (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01449708, which also lists 1 linked publication.
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 21 Mar 2016.