Postoperative Nausea and VomitingPhase 2NicoPONVNCT00553709
Study of Nicotine for the Prevention of PONV
A Phase 2 study testing Nicotine in people with Postoperative Nausea and Vomiting, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine whether nicotine is effective in the prevention of nausea and vomiting in non-smokers undergoing surgery Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Nicotine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2007to Aug 2009
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18-80 years)
- ASA I-II, non-smokers (or ex-smokers who have not been smoking for more than 2 years)
- Undergoing elective surgery (ENT, abdominal, urological, gynaecological); and
- Consenting to take part in the study will be included.
Who cannot join
- Smokers (cigarette, pipe, cigar)
- Patients undergoing nicotine replacement therapy
- Prolonged postoperative intubation
- Postoperative nasogastric tube
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Anesthesiology, Geneva University Hospitals
Geneva, Canton of Geneva, CH-1211
About this study
Official title: The Role of Transcutaneous Nicotine in the Prevention of Postoperative Nausea and Vomiting in Non-smokers
The purpose of this study is to determine whether nicotine is effective in the prevention of nausea and vomiting in non-smokers undergoing surgery
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Nicotine
- Keywords
- nausea, vomiting, retching, emesis, surgery, anesthesia
- Medical subject headings
- Postoperative Nausea and Vomiting, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotineDrug
Nicotinell® Patch 10 cm2, containing 17.5 mg of nicotine, with an average delivery rate of 7 mg of nicotine per 24 hours (= TTS 10)
| Study group | Role | What they receive |
|---|---|---|
| Nicotine patch | Experimental | Nicotinell® Patch 10 cm2, containing 17.5 mg of nicotine, with an average delivery rate of 7 mg of nicotine per 24 hours (= TTS 10) Receives: Drug: Nicotine |
| Placebo patch | Placebo comparator | Placebo patch 10 cm2 Receives: Drug: Nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of PONV
Measured: 48 hours postoperatively
Secondary outcomes (1)
Adverse effects that may be related to the nicotine patch, for instance, local skin reaction.
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Unexpected difficult recruitment. Study drug expired
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 University Hospital, GenevaThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Investigators
- Martin R Tramèr, MD, DPhil, Study chair, University Hospital, GenevaDaniel Bertrand, PhD, Study chair, Medical Faculty, Geneva University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553709
- Sponsor's protocol ID
- 2006DR3327
- Other IDs
- APSIC 04-010
- Acronym
- NicoPONV
- Status last verified
- Sep 2009
- First submitted
- 2 Nov 2007
- Last updated
- 29 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Transcutaneous Nicotine in the Prevention of Postoperative Nausea and Vomiting in Non-smokers
- ClinicalTrials.gov ID
- NCT00553709
- Acronym / sponsor ID
- NicoPONV / 2006DR3327
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- nausea, vomiting, retching, emesis, surgery, anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unexpected difficult recruitment. Study drug expired
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 5 Nov 2007 (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 study is to determine whether nicotine is effective in the prevention of nausea and vomiting in non-smokers undergoing surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine patch | Experimental | Drug: NicotineNicotinell® Patch 10 cm2, containing 17.5 mg of nicotine, with an average delivery rate of 7 mg of nicotine per 24 hours (= TTS 10) |
| Placebo patch | Placebo comparator | Drug: NicotinePlacebo patch 10 cm2 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (18-80 years)
- ASA I-II, non-smokers (or ex-smokers who have not been smoking for more than 2 years)
- Undergoing elective surgery (ENT, abdominal, urological, gynaecological); and
- Consenting to take part in the study will be included.
Key exclusion criteria (4 listed)
- Smokers (cigarette, pipe, cigar)
- Patients undergoing nicotine replacement therapy
- Prolonged postoperative intubation
- Postoperative nasogastric tube
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 |
|---|---|---|
| NicotineNicotinell® Patch 10 cm2, containing 17.5 mg of nicotine, with an average delivery rate of 7 mg of nicotine per 24 hours (= TTS 10) | Drug | Nicotine patch, Placebo patch |
Primary outcome
Prevention of PONV
Time frame: 48 hours postoperatively
1 secondary outcome
Adverse effects that may be related to the nicotine patch, for instance, local skin reaction.
Time frame: 48 hours postoperatively
Results and safety
The study was stopped early (reason given: Unexpected difficult recruitment. Study drug expired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2009.
Related trials for Postoperative Nausea and Vomiting
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
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, 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.
Martin R Tramèr, MD, DPhil study chair
University Hospital, Geneva
Daniel Bertrand, PhD study chair
Medical Faculty, Geneva University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotine in people with Postoperative Nausea and Vomiting, run by University Hospital, Geneva at 1 site in Switzerland.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 29 Sep 2009. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Unexpected difficult recruitment. Study drug expired). Results are not available in the source record.
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?
Prevention of PONV (time frame: 48 hours postoperatively). 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 29 Sep 2009.