NauseaPhase 4DIPAVONCT00445055
Evaluation of 2 Doses of Intravenous Droperidol in the Prevention of Postoperative Nausea
A Phase 4 study testing Droperidol in people with Nausea and Vomiting, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
In this prospective, randomised, placebo-controlled study, the researchers determined whether 0.625 mg or 2.5 mg of IV droperidol given 30 min before emergence from general anaesthesia reduces the incidence of immediate and delayed post operative nausea and vomiting (PONV) in thyroid surgical female population. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Droperidol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2007to Apr 2009
- Phase
- Phase 4
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- More than 18 years old
- Patients scheduled for thyroid surgery
- Simplified Apfel score ≥ 2
- ASA score : 1-2
- Informed consent obtained from the patient
- Women able to procreate must have a reliable contraceptive method
Who cannot join
- Age < 18 years old
- Male
- Obesity
- Has a severe depressive syndrome
- Pregnancy women
- Trouble with cardiac rate
- Alcoholism
- Contra-indication for Droperidol prescription
Trial locations and contacts
1 site in 1 country.
France1 site
Département d'Anesthésie-Réanimation II ; Groupe Hospitalier Sud, CHU de Bordeaux
Pessac, 33604
About this study
Official title: Study of Evaluation of the Profile of Efficiency / Tolerance of 2 Doses of Intravenous Droperidol in the Prevention of the Postoperative Nausea and Vomits Related to the Surgery of the Thyroid
In this prospective, randomised, placebo-controlled study, the researchers determined whether 0.625 mg or 2.5 mg of IV droperidol given 30 min before emergence from general anaesthesia reduces the incidence of immediate and delayed post operative nausea and vomiting (PONV) in thyroid surgical female population. Two hundred and forty six female patients receiving general anaesthesia for thyroid surgery received either droperidol 0.625 mg or droperidol 2.5 mg or placebo before emergence.
Read the detailed description
- Principal Objective : Our study examined one main question: Are there difference in efficacy between droperidol IV 0.625 mg or 2.5 mg for the treatment or prophylaxis of PONV to surgical patient undergoing thyroid surgery when they receive it 30 min before emergence from general anaesthesia?
- Secondary Objective :
- comparison of the % of patients in every group:
- having a complete control of their nausea
- requiring secondarily the appeal to another anti-emetic treatment in postoperative
- presenting an Adverse event
- Compare score of sedation in ach groups
- Evaluate electrocardiograph
- Compare the morphine consumption
- Study design : Prospective, randomized, monocenter, double-blind study
- Inclusion criteria :
- Female
- More than 18 years old
- Patients scheduled for thyroid surgery
- Simplified Apfel score ≥ 2
- ASA score : 1-2
- Informed consent obtained from the patient
- the women in age of procreate must have a reliable contraceptive method
- Exclusion criteria :
- age < 18 years old
- male
- obesity
- present a severe depressive syndrome
- pregnancy women
- trouble of cardiac rate
- alcoholism
- contra-indication for Droperidol prescription
- Study plan: three parallel groups will receive 2 different doses of Droperidol or placebo at the end of surgery.
- Group 1: 0,625mg of Droperidol at the end of surgery
- Group 2: 2,5mg of Droperidol at the end of surgery
- Group 3: Placebo at the end of surgery
- Number of subjects : 246
- Being tested
- Droperidol
- Keywords
- Thyroidectomy, Nausea, Vomiting, Droperidol
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DroperidolDrug
Intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intravenous injection of 0,625 mg Droperidol, 30 min before the end of anesthesia Receives: Drug: Droperidol |
| 2 | Experimental | Intravenous injection of 2,5 mg Droperidol, 30 min before the end of anesthesia Receives: Drug: Droperidol |
| 3 | Placebo comparator | Intravenous injection of NaCl 9% (Placebo), 30 min before the end of anesthesia Receives: Drug: Droperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
No vomiting episode
Measured: During the first four hours after intervention
Secondary outcomes (6)
Light nausea
Measured: 24h post operative
Control of nausea
Measured: 24h post operative
Anti-vomiting treatment
Measured: 24h post operative
Adverse events
Measured: 24h post operative
Modification of electrocardiograph
Measured: 30 min and 120 min after injection
- Score of sedation
Measured: 24h post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Kyowa Kirin Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Gérard JANVIER, MD, Study director, University Hospital, BordeauxLaure BAUDOUIN, Dr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445055
- Sponsor's protocol ID
- CHUBX 2006/02
- Acronym
- DIPAVO
- Status last verified
- Dec 2011
- First submitted
- 6 Mar 2007
- Last updated
- 13 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000 Feb;59(2):213-43. doi: 10.2165/00003495-200059020-00005.
PubMed 10730546Williams OA, Clarke FL, Harris RW, Smith P, Peacock JE. Addition of droperidol to patient-controlled analgesia: effect on nausea and vomiting. Anaesthesia. 1993 Oct;48(10):881-4. doi: 10.1111/j.1365-2044.1993.tb07419.x.
PubMed 8031342Gan TJ, Meyer T, Apfel CC, Chung F, Davis PJ, Eubanks S, Kovac A, Philip BK, Sessler DI, Temo J, Tramer MR, Watcha M; Department of Anesthesiology, Duke University Medical Center. Consensus guidelines for managing postoperative nausea and vomiting. Anesth Analg. 2003 Jul;97(1):62-71, table of contents. doi: 10.1213/01.ane.0000068580.00245.95.
PubMed 12818945Wang JJ, Ho ST, Lee SC, Liu YC, Liu YH, Liao YC. The prophylactic effect of dexamethasone on postoperative nausea and vomiting in women undergoing thyroidectomy: a comparison of droperidol with saline. Anesth Analg. 1999 Jul;89(1):200-3. doi: 10.1097/00000539-199907000-00036.
PubMed 10389804Henzi I, Sonderegger J, Tramer MR. Efficacy, dose-response, and adverse effects of droperidol for prevention of postoperative nausea and vomiting. Can J Anaesth. 2000 Jun;47(6):537-51. doi: 10.1007/BF03018945.
PubMed 10875717
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Evaluation of the Profile of Efficiency / Tolerance of 2 Doses of Intravenous Droperidol in the Prevention of the Postoperative Nausea and Vomits Related to the Surgery of the Thyroid
- ClinicalTrials.gov ID
- NCT00445055
- Acronym / sponsor ID
- DIPAVO / CHUBX 2006/02
- Keywords
- Thyroidectomy, Nausea, Vomiting, Droperidol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Kyowa Kirin Co., Ltd.
- Study start
- Apr 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 8 Mar 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.
In this prospective, randomised, placebo-controlled study, the researchers determined whether 0.625 mg or 2.5 mg of IV droperidol given 30 min before emergence from general anaesthesia reduces the incidence of immediate and delayed post operative nausea and vomiting (PONV) in thyroid surgical female population. Two hundred and forty six female patients receiving general anaesthesia for thyroid surgery received either droperidol 0.625 mg or droperidol 2.5 mg or placebo before emergence.
Detailed description
- Principal Objective : Our study examined one main question: Are there difference in efficacy between droperidol IV 0.625 mg or 2.5 mg for the treatment or prophylaxis of PONV to surgical patient undergoing thyroid surgery when they receive it 30 min before emergence from general anaesthesia?
- Secondary Objective :
- comparison of the % of patients in every group:
- having a complete control of their nausea
- requiring secondarily the appeal to another anti-emetic treatment in postoperative
- presenting an Adverse event
- Compare score of sedation in ach groups
- Evaluate electrocardiograph
- Compare the morphine consumption
- Study design : Prospective, randomized, monocenter, double-blind study
- Inclusion criteria :
- Female
- More than 18 years old
- Patients scheduled for thyroid surgery
- Simplified Apfel score ≥ 2
- ASA score : 1-2
- Informed consent obtained from the patient
- the women in age of procreate must have a reliable contraceptive method
- Exclusion criteria :
- age < 18 years old
- male
- obesity
- present a severe depressive syndrome
- pregnancy women
- trouble of cardiac rate
- alcoholism
- contra-indication for Droperidol prescription
- Study plan: three parallel groups will receive 2 different doses of Droperidol or placebo at the end of surgery.
- Group 1: 0,625mg of Droperidol at the end of surgery
- Group 2: 2,5mg of Droperidol at the end of surgery
- Group 3: Placebo at the end of surgery
- Number of subjects : 246
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DroperidolIntravenous injection of 0,625 mg Droperidol, 30 min before the end of anesthesia |
| 2 | Experimental | Drug: DroperidolIntravenous injection of 2,5 mg Droperidol, 30 min before the end of anesthesia |
| 3 | Placebo comparator | Drug: DroperidolIntravenous injection of NaCl 9% (Placebo), 30 min before the end of anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female
- More than 18 years old
- Patients scheduled for thyroid surgery
- Simplified Apfel score ≥ 2
- ASA score : 1-2
Key exclusion criteria (8 listed)
- Age < 18 years old
- Male
- Obesity
- Has a severe depressive syndrome
- Pregnancy women
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 |
|---|---|---|
| DroperidolIntravenous injection | Drug | 1, 2, 3 |
Primary outcome
No vomiting episode
Time frame: During the first four hours after intervention
6 secondary outcomes
Light nausea
Time frame: 24h post operative
Control of nausea
Time frame: 24h post operative
Anti-vomiting treatment
Time frame: 24h post operative
Adverse events
Time frame: 24h post operative
Modification of electrocardiograph
Time frame: 30 min and 120 min after injection
- Score of sedation
Time frame: 24h post operative
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
- Background: PubMed 10730546Kovac AL. Prevention and treatment of postoperative nausea and vomiting. Drugs. 2000 Feb;59(2):213-43. doi: 10.2165/00003495-200059020-00005.
- Background: PubMed 8031342Williams OA, Clarke FL, Harris RW, Smith P, Peacock JE. Addition of droperidol to patient-controlled analgesia: effect on nausea and vomiting. Anaesthesia. 1993 Oct;48(10):881-4. doi: 10.1111/j.1365-2044.1993.tb07419.x.
- Background: PubMed 12818945Gan TJ, Meyer T, Apfel CC, Chung F, Davis PJ, Eubanks S, Kovac A, Philip BK, Sessler DI, Temo J, Tramer MR, Watcha M; Department of Anesthesiology, Duke University Medical Center. Consensus guidelines for managing postoperative nausea and vomiting. Anesth Analg. 2003 Jul;97(1):62-71, table of contents. doi: 10.1213/01.ane.0000068580.00245.95.
- Background: PubMed 10389804Wang JJ, Ho ST, Lee SC, Liu YC, Liu YH, Liao YC. The prophylactic effect of dexamethasone on postoperative nausea and vomiting in women undergoing thyroidectomy: a comparison of droperidol with saline. Anesth Analg. 1999 Jul;89(1):200-3. doi: 10.1097/00000539-199907000-00036.
- Background: PubMed 10875717Henzi I, Sonderegger J, Tramer MR. Efficacy, dose-response, and adverse effects of droperidol for prevention of postoperative nausea and vomiting. Can J Anaesth. 2000 Jun;47(6):537-51. doi: 10.1007/BF03018945.
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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.
Gérard JANVIER, MD study director
University Hospital, Bordeaux
Laure BAUDOUIN, Dr principal investigator
University Hospital, Bordeaux
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 Droperidol in people with Nausea and Vomiting, run by University Hospital, Bordeaux at 1 site in France.
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 7 inclusion and 8 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 13 Dec 2011. 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 France. 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 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?
The study was stopped early. 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?
No vomiting episode (time frame: During the first four hours after intervention). 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 NCT00445055, which also lists 5 linked publications.
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 13 Dec 2011.