Varicose VeinNCT00712517
Propofol Versus Volatile Anesthesia in Post Operative Pain Management
A study testing propofol and sevoflurane in people with Varicose Vein and Postoperative Pain, run by The Cleveland Clinic at 1 site in Austria.
Trial summary
The study will test the hypothesis that patients anesthetized with propofol suffer less postoperative pain than those anesthetized with sevoflurane. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Vein, Postoperative Pain
- What is being tested?
- propofol and sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2010to May 2014
- 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
- Participants will undergo a stripping operation for varicose veins
- Surgery will be performed by one physician only
- Written informed consent
Who cannot join
- Any contraindications to the proposed interventions
- Procedures done under regional anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Patients Anesthetized With Propofol Have Less Pain Than Those Anesthetized With Volatile?
The study will test the hypothesis that patients anesthetized with propofol suffer less postoperative pain than those anesthetized with sevoflurane.
Read the detailed description
Patients undergoing s stripping operation for varicose veins will be randomized to one of two groups. Group 1 patients will receive propofol anesthesia. Group 2 patients will receive sevoflurane anesthesia. Intraoperative measurements including mean-arterial pressure, heart rate, propofol infusion rate, remifentanil infusion rate, and end-tidal sevoflurane concentration will be taken at 15 minute intervals. Patients in both groups will receive Piritramid as necessary to control pain either intravenously or through patient controlled pump. VAS pain score, mean-arterial pressure, heart rate, nausea will be evaluated at 30 minute intervals during the first four postoperative hours. Piritramid dosage and vomiting will be recorded through the first postoperative morning. Patients will rate pain based on the VAS score for the period between leaving the recovery room and the first postoperative morning
- Conditions
- Varicose Vein, Postoperative Pain
- Being tested
- propofol, sevoflurane
- Keywords
- postoperative pain, Piritramid, propofol, sevoflurane, varicose vein, Anesthesia
- Medical subject headings
- Varicose Veins, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called Diprivan
propofol anesthesia 3-5mg/kg
sevofluraneDrug
sevoflurane anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients will receive propofol anesthesia during varicose vein stripping surgery. Receives: Drug: propofol |
| 2 | Active comparator | Patients will receive sevoflurane anesthesia during varicose vein stripping surgery. Receives: Drug: sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is morphine-equivalent use from the end of surgery until the first post-operative morning.
Measured: first post operative morning
Secondary outcomes (1)
To determine the average pain score for each group during the first four hours of recovery after surgery.
Measured: 30 minute intervals for first 4 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startSep 2010
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Enrolling of participants has halted and the results are being gathered
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 Varicose VeinStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olga Plattner, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712517
- Sponsor's protocol ID
- 42908
- Status last verified
- Jul 2016
- First submitted
- 7 Jul 2008
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Windpassinger M, Plattner O, Gemeiner J, Bohler K, Luntzer R, Klimscha W, Yang D, Mascha EJ, Sessler DI. Opioid use after propofol or sevoflurane anesthesia: a randomized trial. Can J Anaesth. 2016 Nov;63(11):1258-65. doi: 10.1007/s12630-016-0728-5. Epub 2016 Sep 14.
PubMed 27638296
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Patients Anesthetized With Propofol Have Less Pain Than Those Anesthetized With Volatile?
- ClinicalTrials.gov ID
- NCT00712517
- Acronym / sponsor ID
- 42908
- Conditions
- Varicose Vein, Postoperative Pain
- Keywords
- postoperative pain, Piritramid, propofol, sevoflurane, varicose vein, Anesthesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrolling of participants has halted and the results are being gathered
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 10 Jul 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.
The study will test the hypothesis that patients anesthetized with propofol suffer less postoperative pain than those anesthetized with sevoflurane.
Detailed description
Patients undergoing s stripping operation for varicose veins will be randomized to one of two groups. Group 1 patients will receive propofol anesthesia. Group 2 patients will receive sevoflurane anesthesia. Intraoperative measurements including mean-arterial pressure, heart rate, propofol infusion rate, remifentanil infusion rate, and end-tidal sevoflurane concentration will be taken at 15 minute intervals. Patients in both groups will receive Piritramid as necessary to control pain either intravenously or through patient controlled pump. VAS pain score, mean-arterial pressure, heart rate, nausea will be evaluated at 30 minute intervals during the first four postoperative hours. Piritramid dosage and vomiting will be recorded through the first postoperative morning. Patients will rate pain based on the VAS score for the period between leaving the recovery room and the first postoperative morning
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: propofolPatients will receive propofol anesthesia during varicose vein stripping surgery. |
| 2 | Active comparator | Drug: sevofluranePatients will receive sevoflurane anesthesia during varicose vein stripping surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants will undergo a stripping operation for varicose veins
- Surgery will be performed by one physician only
- Written informed consent
Key exclusion criteria (2 listed)
- Any contraindications to the proposed interventions
- Procedures done under regional anesthesia
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 |
|---|---|---|
| propofolAlso: Diprivanpropofol anesthesia 3-5mg/kg | Drug | 1 |
| sevofluranesevoflurane anesthesia | Drug | 2 |
Primary outcome
The primary outcome is morphine-equivalent use from the end of surgery until the first post-operative morning.
Time frame: first post operative morning
1 secondary outcome
To determine the average pain score for each group during the first four hours of recovery after surgery.
Time frame: 30 minute intervals for first 4 hours post operatively
Results and safety
The study was stopped early (reason given: Enrolling of participants has halted and the results are being gathered). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Derived from this study: PubMed 27638296Windpassinger M, Plattner O, Gemeiner J, Bohler K, Luntzer R, Klimscha W, Yang D, Mascha EJ, Sessler DI. Opioid use after propofol or sevoflurane anesthesia: a randomized trial. Can J Anaesth. 2016 Nov;63(11):1258-65. doi: 10.1007/s12630-016-0728-5. Epub 2016 Sep 14.
- Individual participant dataSharing planned: No
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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.
Olga Plattner, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propofol and sevoflurane in people with Varicose Vein and Postoperative Pain, run by The Cleveland Clinic at 1 site in Austria.
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 3 inclusion and 2 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 20 Jul 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 Austria. 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.
Are results available for this study?
The study was stopped early (reason given: Enrolling of participants has halted and the results are being gathered). 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?
The primary outcome is morphine-equivalent use from the end of surgery until the first post-operative morning. (time frame: first post operative morning). 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 NCT00712517, 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 20 Jul 2016.