Induction of Total Intravenous General AnesthesiaPhase 3NCT00146926
Comparison of Three Different Strategies to Prevent Propofol Induced Pain During Infusion
A Phase 3 study testing kétamine 20mg, ephedrine 3mg and lidocaine 40mg in people with Induction of Total Intravenous General Anesthesia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Propofol is a popular intravenous drug to induce anesthesia but it causes local pain with an incidence between 40 and 90%. Three different strategies to prevent propofol induced pain will be studied compared with placebo. Pain will be scored with a four-point scale. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Induction of Total Intravenous General Anesthesia
- What is being tested?
- kétamine 20mg, ephedrine 3mg and lidocaine 40mg
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2005to not given
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy adults (ASA 1-2) for scheduled surgery under general anesthesia with propofol
Who cannot join
- pregnant
- sedative or analgesic drug 24h before surgery
- allergy with drug used in the study
- difficulty of communication
- absence of informed written consent
Trial locations and contacts
1 site in 1 country.
About this study
Propofol is a popular intravenous drug to induce anesthesia but it causes local pain with an incidence between 40 and 90%. Three different strategies to prevent propofol induced pain will be studied compared with placebo. Pain will be scored with a four-point scale.
- Being tested
- kétamine 20mg, ephedrine 3mg, lidocaine 40mg
- Keywords
- Propofol, pain, general anesthesia, prevention
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kétamine 20mgDrug
ephedrine 3mgDrug
lidocaine 40mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
After prophylactic solution, evaluation of the pain caused by injection of propofol with a four-point scale before lose of consciousness
Secondary outcomes (2)
Explicite and implicite memory of pain immediately after surgery and on day one
Adverse effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of Total Intravenous General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Vincent PIRIOU, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146926
- Sponsor's protocol ID
- 2004.367
- Status last verified
- Apr 2007
- First submitted
- 5 Sep 2005
- Last updated
- 27 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Different Strategies to Prevent Propofol Induced Pain During Infusion
- ClinicalTrials.gov ID
- NCT00146926
- Acronym / sponsor ID
- 2004.367
- Keywords
- Propofol, pain, general anesthesia, prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2005
- First posted
- 7 Sep 2005 (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.
Propofol is a popular intravenous drug to induce anesthesia but it causes local pain with an incidence between 40 and 90%. Three different strategies to prevent propofol induced pain will be studied compared with placebo. Pain will be scored with a four-point scale.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults (ASA 1-2) for scheduled surgery under general anesthesia with propofol
Key exclusion criteria (5 listed)
- pregnant
- sedative or analgesic drug 24h before surgery
- allergy with drug used in the study
- difficulty of communication
- absence of informed written consent
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 |
|---|---|---|
| kétamine 20mg | Drug | – |
| ephedrine 3mg | Drug | – |
| lidocaine 40mg | Drug | – |
Primary outcome
After prophylactic solution, evaluation of the pain caused by injection of propofol with a four-point scale before lose of consciousness
2 secondary outcomes
Explicite and implicite memory of pain immediately after surgery and on day one
Adverse effects
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2007.
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.
Vincent PIRIOU, MD principal investigator
Hospices Civils de Lyon
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 kétamine 20mg, ephedrine 3mg and lidocaine 40mg in people with Induction of Total Intravenous General Anesthesia, run by Hospices Civils de Lyon 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Apr 2007. 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. 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?
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?
After prophylactic solution, evaluation of the pain caused by injection of propofol with a four-point scale before lose of consciousness. 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 27 Apr 2007.