AnesthesiaPhase 3LoopLidoNCT01154738
Lidocaine and Closed-Loop Anesthesia System
A Phase 3 study testing Lidocaine in people with Anesthesia, run by Hopital Foch at 1 site in France.
Trial summary
The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients ASA 1, 2 or 3 scheduled for a general anesthesia surgical procedure (abdominal surgery, urology, ENT major procedure) lasting between 1 and 3 hours
Who cannot join
- age under 18 years
- simultaneous general and loco-regional anesthesia
- allergy to NSAID
- treatment with verapamil, ketamine or gabapentin
- patients receiving an opioid preoperatively
- severe hepatic insufficiency
Show all 11Show fewer
- contra-indication to lidocaine
- contra-indication to propofol or to remifentanil
- history of central nervous system disease
- patients receiving a psychotropic treatment
- patients with a pace-maker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Lidocaine on a Closed-Loop Anesthesia System
The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil.
- Conditions
- Anesthesia
- Being tested
- Lidocaine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
bolus dose of lidocaine (1.5 mg.kg-1) followed by an infusion of lidocaine (2 mg.kg-1 h-1) until the end of anesthesia.
start of the induction of anesthesia 10 minutes after the bolus dose of lidocaine
PlaceboDrug
NaCl 9/00 (same volume as in the lidocaine group)
start of the induction of anesthesia 10 minutes after the bolus dose of NaCl 9/00
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Lidocaine Receives: Drug: Lidocaine |
| Placebo | Placebo comparator | patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
administered dose of propofol during maintenance of anesthesia
Measured: day 1
Secondary outcomes (8)
administered dose of propofol during induction of anesthesia
Measured: day 1
administered doses of remifentanil during induction and maintenance of anesthesia
Measured: day 1
delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia
Measured: day 1
hemodynamic abnormalities requiring treatment
Measured: day 1
% of time with a BIS index between 40 and 60
Measured: day 1
postoperative morphine requirement
Measured: day 1
incidence of postoperative nausea and vomiting
Measured: day 1
% of patients with an explicit memorisation of the intraoperative period
Measured: second postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, MD, Study chair, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154738
- Sponsor's protocol ID
- 2010/18
- Other IDs
- 2010-019979-29
- Acronym
- LoopLido
- Status last verified
- Nov 2016
- First submitted
- 25 Jun 2010
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Lidocaine on a Closed-Loop Anesthesia System
- ClinicalTrials.gov ID
- NCT01154738
- Acronym / sponsor ID
- LoopLido / 2010/18
- Conditions
- Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 1 Jul 2010 (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 objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: LidocainePatients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Lidocaine |
| Placebo | Placebo comparator | Drug: Placebopatients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo |
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 ASA 1, 2 or 3 scheduled for a general anesthesia surgical procedure (abdominal surgery, urology, ENT major procedure) lasting between 1 and 3 hours
Key exclusion criteria (11 listed)
- age under 18 years
- simultaneous general and loco-regional anesthesia
- allergy to NSAID
- treatment with verapamil, ketamine or gabapentin
- patients receiving an opioid preoperatively
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 |
|---|---|---|
| Lidocainebolus dose of lidocaine (1.5 mg.kg-1) followed by an infusion of lidocaine (2 mg.kg-1 h-1) until the end of anesthesia. start of the induction of anesthesia 10 minutes after the bolus dose of lidocaine | Drug | Lidocaine |
| PlaceboNaCl 9/00 (same volume as in the lidocaine group) start of the induction of anesthesia 10 minutes after the bolus dose of NaCl 9/00 | Drug | Placebo |
Primary outcome
administered dose of propofol during maintenance of anesthesia
Time frame: day 1
8 secondary outcomes
administered dose of propofol during induction of anesthesia
Time frame: day 1
administered doses of remifentanil during induction and maintenance of anesthesia
Time frame: day 1
delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia
Time frame: day 1
hemodynamic abnormalities requiring treatment
Time frame: day 1
% of time with a BIS index between 40 and 60
Time frame: day 1
postoperative morphine requirement
Time frame: day 1
incidence of postoperative nausea and vomiting
Time frame: day 1
% of patients with an explicit memorisation of the intraoperative period
Time frame: second postoperative day
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 3 Nov 2016.
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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.
Marc Fischler, MD study chair
Hôpital Foch
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 Lidocaine in people with Anesthesia, run by Hopital Foch 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 11 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 3 Nov 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 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 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?
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?
administered dose of propofol during maintenance of anesthesia (time frame: day 1). 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 3 Nov 2016.