Thyroid Surgery for Benign DiseaseNCT00619086
Steroid Before Thyroidectomy
A study testing Dexamethason Helvepharm ® in people with Thyroid Surgery for Benign Disease, run by University of Bern at 1 site in Switzerland.
Trial summary
We evaluated the effects of giving a single dose of steroid before thyroid surgery in a single institutional, double-blinded, randomized controlled trial. Postoperative nausea, pain, and vocal function were significantly improved after steroid administration compared to controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Surgery for Benign Disease
- What is being tested?
- Dexamethason Helvepharm ®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2005to Jun 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing thyroid surgery for benign disease
Who cannot join
- Depression
- Chronic pain disorder
- Insulin dependent diabetes mellitus
- History of PONV
- Pregnancy
- Age < 18 years
- Received antiemetic therapy within 48 hours
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of visceral- and transplant surgery
Bern, 3010
About this study
Official title: Does a Single Dose of Steroid Before Thyroidectomy Improve Postoperative Nausea, Pain and Vocal Function?
We evaluated the effects of giving a single dose of steroid before thyroid surgery in a single institutional, double-blinded, randomized controlled trial. Postoperative nausea, pain, and vocal function were significantly improved after steroid administration compared to controls.
- Conditions
- Thyroid Surgery for Benign Disease
- Being tested
- Dexamethason Helvepharm ®, Placebo
- Keywords
- thyroidectomy, dexamethasone, steroid, nausea
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethason Helvepharm ®Drug
8 mg Dexamethason i.v. 45 minutes prior to surgery
PlaceboDrug
100 ml sodium chloride i.v. 45 minutes prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| A, 1 | Placebo comparator | Placebo 45 minutes prior to surgery Receives: Drug: Placebo |
| A, 2 | Active comparator | 8 mg Dexamethasone 45 minutes prior to surgery Receives: Drug: Dexamethason Helvepharm ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea
Measured: 0-72 hours postoperative
Secondary outcomes (1)
Pain, vocal function
Measured: 0-72 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startNov 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid Surgery for Benign DiseaseStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Investigators
- Stephan A. Vorburger, MD, Principal investigator, Dept of visceral- and transplant surgery, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619086
- Sponsor's protocol ID
- KEK_49_05
- Status last verified
- Jun 2008
- First submitted
- 7 Feb 2008
- Last updated
- 9 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Worni M, Schudel HH, Seifert E, Inglin R, Hagemann M, Vorburger SA, Candinas D. Randomized controlled trial on single dose steroid before thyroidectomy for benign disease to improve postoperative nausea, pain, and vocal function. Ann Surg. 2008 Dec;248(6):1060-6. doi: 10.1097/SLA.0b013e31818c709a.
PubMed 19092351
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Single Dose of Steroid Before Thyroidectomy Improve Postoperative Nausea, Pain and Vocal Function?
- ClinicalTrials.gov ID
- NCT00619086
- Acronym / sponsor ID
- KEK_49_05
- Conditions
- Thyroid Surgery for Benign Disease
- Keywords
- thyroidectomy, dexamethasone, steroid, nausea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- Nov 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 20 Feb 2008 (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.
We evaluated the effects of giving a single dose of steroid before thyroid surgery in a single institutional, double-blinded, randomized controlled trial. Postoperative nausea, pain, and vocal function were significantly improved after steroid administration compared to controls.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, 1 | Placebo comparator | Drug: PlaceboPlacebo 45 minutes prior to surgery |
| A, 2 | Active comparator | Drug: Dexamethason Helvepharm ®8 mg Dexamethasone 45 minutes prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing thyroid surgery for benign disease
Key exclusion criteria (7 listed)
- Depression
- Chronic pain disorder
- Insulin dependent diabetes mellitus
- History of PONV
- Pregnancy
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 |
|---|---|---|
| Dexamethason Helvepharm ®8 mg Dexamethason i.v. 45 minutes prior to surgery | Drug | A, 2 |
| Placebo100 ml sodium chloride i.v. 45 minutes prior to surgery | Drug | A, 1 |
Primary outcome
Nausea
Time frame: 0-72 hours postoperative
1 secondary outcome
Pain, vocal function
Time frame: 0-72 hours postoperative
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 9 Jun 2008.
- Derived from this study: PubMed 19092351Worni M, Schudel HH, Seifert E, Inglin R, Hagemann M, Vorburger SA, Candinas D. Randomized controlled trial on single dose steroid before thyroidectomy for benign disease to improve postoperative nausea, pain, and vocal function. Ann Surg. 2008 Dec;248(6):1060-6. doi: 10.1097/SLA.0b013e31818c709a.
Related trials for Thyroid Surgery for Benign Disease
Not yet recruitingObservational study
Thyroid Health Outcomes Registry for Surgery
Thyroid Diseases, Thyroid Neoplasms
RecruitingObservational study
Cognition and QoL After Thyroid Surgery
Thyroid Nodule, Thyroid Cancer
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.
Stephan A. Vorburger, MD principal investigator
Dept of visceral- and transplant surgery, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethason Helvepharm ® in people with Thyroid Surgery for Benign Disease, run by University of Bern 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 1 inclusion and 7 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 9 Jun 2008. 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.
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?
Nausea (time frame: 0-72 hours postoperative). 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 NCT00619086, 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 9 Jun 2008.