AnesthesiaPhase 3NCT00690495
Use of a Modified Propofol Emulsion in Adults
A Phase 3 study testing Propofol and Propofol 1% in people with Anesthesia, run by B. Braun Melsungen AG at 1 site in Germany.
Trial summary
The purpose of the study is to determine whether a modified propofol preparation shows any effect on the incidence of injection pain in adults undergoing elective surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Propofol and Propofol 1%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to Sep 2008
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults, age ≥ 18 years and ≤ 80 years
- Anesthetic risk classified as ASA I-III
- Patients undergoing elective surgery under general anesthesia
- Signed informed consent
Who cannot join
- Simultaneous participation in another trial
- Known or suspected drug abuse
- Known hypersensitivity to Propofol, other ingredients of the emulsion, or to any other necessary co-medication
- Not allowed concomitant medication (psychopharmacologic agents, tranquilizers, or centrally active analgesics)
- Patients taking lipid lowering drugs
- History of decompensated renal failure
Show all 17Show fewer
- History of severe hepatic dysfunction, hepatic cirrhosis
- Angiographically confirmed CHD (coronary heart disease) or cerebral ischemia
- History of convulsive disorders
- Decompensated cardiac insufficiency
- Hypovolemia
- Increased intracranial pressure
- Pregnancy (positive ß-HCG test) and lactation
- Emergency situation
- Patient who receives parenteral fat emulsion, e.g. intralipid
- Patients incapable of giving consent personally
- Venous access for induction of anesthesia not possible at dorsum of the hand or not dorsal
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH
Leverkusen, North Rhine-Westphalia, 51375
About this study
Official title: Prospective, Monocentric Controlled, Randomized, Double-blind Study to Compare the Two Different Propofol Emulsions Regarding Tolerability and Injection Pain During the Induction of Anesthesia in Adults
The purpose of the study is to determine whether a modified propofol preparation shows any effect on the incidence of injection pain in adults undergoing elective surgery under general anesthesia.
Study hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.
Read the detailed description
Pain on injection is a most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on injection had been reduced with some of the above mentioned methods, they may not be regarded as a satisfactory solution of the problem.
- Conditions
- Anesthesia
- Being tested
- Propofol, Propofol 1%
- Keywords
- Anesthesia, Induction, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Modified propofol
Propofol (drug), intravenous, induction of anesthesia
Propofol 1%Drug
Also called Propofol-Lipuro 1%
Propofol (drug), intravenous, induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Modified propofol (Propofol 0.5%) Receives: Drug: Propofol |
| 2 | Active comparator | Propofol 1% Receives: Drug: Propofol 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Expression of Pain During Injection
Measured: during first propofol bolus
Secondary outcomes (1)
Further Assessment of Injection Pain
Measured: during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2008
- Study completionSep 2008
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 AnesthesiaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Soltész, MD, PhD, Principal investigator, Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690495
- Sponsor's protocol ID
- HC-G-H-0705
- Status last verified
- Jan 2012
- First submitted
- 2 Jun 2008
- Last updated
- 5 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Soltesz S, Diekmann M, Mitrenga-Theusinger A, Keilen M, Molter GP. Reduced pain on injection with a 0.5% propofol emulsion during induction of anesthesia. Eur J Anaesthesiol. 2012 Mar;29(3):162-3. doi: 10.1097/EJA.0b013e32834cfa7d. No abstract available.
PubMed 22012178
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Monocentric Controlled, Randomized, Double-blind Study to Compare the Two Different Propofol Emulsions Regarding Tolerability and Injection Pain During the Induction of Anesthesia in Adults
- ClinicalTrials.gov ID
- NCT00690495
- Acronym / sponsor ID
- HC-G-H-0705
- Conditions
- Anesthesia
- Keywords
- Anesthesia, Induction, Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 4 Jun 2008 (estimated)
- Results
- Posted 22 Sep 2011
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 the study is to determine whether a modified propofol preparation shows any effect on the incidence of injection pain in adults undergoing elective surgery under general anesthesia.
Study hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.
Detailed description
Pain on injection is a most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on injection had been reduced with some of the above mentioned methods, they may not be regarded as a satisfactory solution of the problem.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PropofolModified propofol (Propofol 0.5%) |
| 2 | Active comparator | Drug: Propofol 1%Propofol 1% |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female adults, age ≥ 18 years and ≤ 80 years
- Anesthetic risk classified as ASA I-III
- Patients undergoing elective surgery under general anesthesia
- Signed informed consent
Key exclusion criteria (17 listed)
- Simultaneous participation in another trial
- Known or suspected drug abuse
- Known hypersensitivity to Propofol, other ingredients of the emulsion, or to any other necessary co-medication
- Not allowed concomitant medication (psychopharmacologic agents, tranquilizers, or centrally active analgesics)
- Patients taking lipid lowering drugs
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: Modified propofolPropofol (drug), intravenous, induction of anesthesia | Drug | 1 |
| Propofol 1%Also: Propofol-Lipuro 1%Propofol (drug), intravenous, induction of anesthesia | Drug | 2 |
Primary outcome
Incidence of Expression of Pain During Injection
Time frame: during first propofol bolus
1 secondary outcome
Further Assessment of Injection Pain
Time frame: during induction of anaesthesia and about 3 to 6 hours after end of anaesthesia
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22012178Soltesz S, Diekmann M, Mitrenga-Theusinger A, Keilen M, Molter GP. Reduced pain on injection with a 0.5% propofol emulsion during induction of anesthesia. Eur J Anaesthesiol. 2012 Mar;29(3):162-3. doi: 10.1097/EJA.0b013e32834cfa7d. No abstract available.
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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.
Stefan Soltész, MD, PhD principal investigator
Klinik für Anästhesie und operative Intensivmedizin, Klinikum Leverkusen gGmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propofol and Propofol 1% in people with Anesthesia, run by B. Braun Melsungen AG at 1 site in Germany.
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 17 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 5 Jan 2012. 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 Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 22 Sep 2011). 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?
Incidence of Expression of Pain During Injection (time frame: during first propofol bolus). 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 NCT00690495, 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 5 Jan 2012.