Intravenous Anesthetic Interaction "Unrecognized Condition"Phase 4NCT01366300
Effect of Intravenous Lidocaine on BIS-guided Propofol Requirements During General Anesthesia
A Phase 4 study testing Intravenous lidocaine infusion, Propofol 1% (intravenous infusion) and Placement of arterial line in people with Intravenous Anesthetic Interaction "Unrecognized Condition", run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The purpose of this randomized clinical trial is to evaluate the interaction of lidocaine infusion initiated and maintained during surgery, on propofol requirements during general anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intravenous Anesthetic Interaction "Unrecognized Condition"
- What is being tested?
- Intravenous lidocaine infusion, Propofol 1% (intravenous infusion) and Placement of arterial line
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChile
- Study dates
- Jun 2010to Jun 2011
- Phase
- Phase 4
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I-II patients,
- Between 20 and 65 years of age
- Programed for elective laparoscopic cholecystectomy
- Eligible for total intravenous anesthesia with propofol
Who cannot join
- Unwillingness to participate in the study
- Adverse reactions to the drugs used in the study
- Use of medications that interfere in local anesthetic metabolism
- History of liver disease, kidney failure, hypoalbuminemia, hypocalcemia or hypophosphatemia
- History of drug or alcohol abuse
- Chronic use of benzodiazepines
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Clínico Pontificia Universidad Católica de Chile
Santiago, RM, 8330024
About this study
Official title: Estimation of the Effect of Intravenous Lidocaine on BIS-guided Propofol Requirements During General Anesthesia
The purpose of this randomized clinical trial is to evaluate the interaction of lidocaine infusion initiated and maintained during surgery, on propofol requirements during general anesthesia.
Read the detailed description
Use of intravenous lidocaine as a coadjuvant agent during general anesthesia has increased. Lidocaine infusion during and after abdominal surgery decreases postoperative pain and reduces ileus duration, reducing patient´s hospital stay and opioid consumption. Intravenous lidocaine´s effect on other intravenous anesthetics is unclear, and there are no present studies evaluating its interaction on hypnotic anesthetic requirements when using a BIS (Bispectral Index) monitor to maintain an adequate depth of anesthesia. We therefore decided to conduct a randomized controlled trial to evaluate the interaction of systemic lidocaine infusion, initiated and maintained during surgery, on propofol requirements and anesthetic depth as measured by BIS.
- Being tested
- Intravenous lidocaine infusion, Placebo (0.9% saline infusion), Propofol 1% (intravenous infusion), Placement of arterial line
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous lidocaine infusionDrug
Once the dose of propofol required for general anesthesia is stabilized for 5 minutes with BIS values between 40 and 50, lidocaine 1% infusion is begun in a bolus of 1.5mg/kg for 5 minutes and then infused at 2 mg/kg/hr until the end of surgery (last skin suture is made).
Placebo (0.9% saline infusion)Other
Once the dose of propofol required for general anesthesia is stabilized for 5 minutes with BIS values between 40 and 50, 0.9% saline infusion is begun in a bolus of 1.5mg/kg for 5 minutes and then infused at 2 mg/kg/hr until the end of surgery (last skin suture is made).
Propofol 1% (intravenous infusion)Drug
Propofol is administered according to a widely-accepted pharmacokinetic model, initially dosed to a target controlled infusion (TCI) of 4.5 micrograms/ml, and titrated by step increases of 0.5 every minute until loss of conscience is obtained and BIS values are less than 50. During the maintenance phase of anesthesia propofol TCI is actively titrated to maintain BIS values between 40 and 50. If BIS is out of this range for more than 10 seconds, propofol is adjusted in 0.5 ug/mc to maintain BIS values in the predetermined limits.
Placement of arterial lineProcedure or surgery
An arterial line was placed in the anesthetised patient´s right arm by the investigator and arterial samples were obtained every 10 minutes since initiation of the study infusion to determine plasmatic lidocaine and propofol levels (if the infusion was saline the samples were not analyzed). The arterial line was removed before the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous lidocaine infusion | Active comparator | Intravenous lidocaine infusion during total intravenous anesthesia with propofol administered by target controlled infusion Receives: Drug: Intravenous lidocaine infusion; Drug: Propofol 1% (intravenous infusion); Procedure: Placement of arterial line |
| Intravenous 0.9% saline infusion | Placebo comparator | Intravenous 0.9% saline infusion during total intravenous anesthesia with propofol administered by target controlled infusion Receives: Other: Placebo (0.9% saline infusion); Drug: Propofol 1% (intravenous infusion); Procedure: Placement of arterial line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total propofol requirements during bispectral index guided general anesthesia
During and after elective laparoscopic cholecystectomy. Patients' anesthetic depth will be monitored during the intra-operative period using a BIS monitor. Patients' follow up considers the immediate post-operative period at the recovery room (PACU), and it will continue until patients' discharge from the hospital (average 3 days postoperatively).
Measured: DAY 1.
Secondary outcomes (1)
Evaluate effect of intravenous lidocaine infusion on waking time after general anesthesia
Immediately after elective laparoscopic cholecystectomy, during PACU stay. Patients' follow up considers the immediate post-operative period at the recovery room (PACU), and it will continue until patients' discharge from the hospital (average 3 days postoperatively).
Measured: DAY 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startJun 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous Anesthetic Interaction "Unrecognized Condition"Studies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Investigators
- Fernando R Altermatt, MD, Principal investigator, Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366300
- Sponsor's protocol ID
- LPBIS-UC-2010
- Status last verified
- Mar 2011
- First submitted
- 2 Jun 2011
- Last updated
- 6 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of the Effect of Intravenous Lidocaine on BIS-guided Propofol Requirements During General Anesthesia
- ClinicalTrials.gov ID
- NCT01366300
- Acronym / sponsor ID
- LPBIS-UC-2010
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Jun 2011 (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 purpose of this randomized clinical trial is to evaluate the interaction of lidocaine infusion initiated and maintained during surgery, on propofol requirements during general anesthesia.
Detailed description
Use of intravenous lidocaine as a coadjuvant agent during general anesthesia has increased. Lidocaine infusion during and after abdominal surgery decreases postoperative pain and reduces ileus duration, reducing patient´s hospital stay and opioid consumption. Intravenous lidocaine´s effect on other intravenous anesthetics is unclear, and there are no present studies evaluating its interaction on hypnotic anesthetic requirements when using a BIS (Bispectral Index) monitor to maintain an adequate depth of anesthesia. We therefore decided to conduct a randomized controlled trial to evaluate the interaction of systemic lidocaine infusion, initiated and maintained during surgery, on propofol requirements and anesthetic depth as measured by BIS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous lidocaine infusion | Active comparator | Drug: Intravenous lidocaine infusion, Drug: Propofol 1% (intravenous infusion), Procedure: Placement of arterial lineIntravenous lidocaine infusion during total intravenous anesthesia with propofol administered by target controlled infusion |
| Intravenous 0.9% saline infusion | Placebo comparator | Other: Placebo (0.9% saline infusion), Drug: Propofol 1% (intravenous infusion), Procedure: Placement of arterial lineIntravenous 0.9% saline infusion during total intravenous anesthesia with propofol administered by target controlled infusion |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I-II patients,
- Between 20 and 65 years of age
- Programed for elective laparoscopic cholecystectomy
- Eligible for total intravenous anesthesia with propofol
Key exclusion criteria (6 listed)
- Unwillingness to participate in the study
- Adverse reactions to the drugs used in the study
- Use of medications that interfere in local anesthetic metabolism
- History of liver disease, kidney failure, hypoalbuminemia, hypocalcemia or hypophosphatemia
- History of drug or alcohol abuse
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 |
|---|---|---|
| Intravenous lidocaine infusionOnce the dose of propofol required for general anesthesia is stabilized for 5 minutes with BIS values between 40 and 50, lidocaine 1% infusion is begun in a bolus of 1.5mg/kg for 5 minutes and then infused at 2 mg/kg/hr until the end of surgery (last skin suture is made). | Drug | Intravenous lidocaine infusion |
| Placebo (0.9% saline infusion)Once the dose of propofol required for general anesthesia is stabilized for 5 minutes with BIS values between 40 and 50, 0.9% saline infusion is begun in a bolus of 1.5mg/kg for 5 minutes and then infused at 2 mg/kg/hr until the end of surgery (last skin suture is made). | Other | Intravenous 0.9% saline infusion |
| Propofol 1% (intravenous infusion)Propofol is administered according to a widely-accepted pharmacokinetic model, initially dosed to a target controlled infusion (TCI) of 4.5 micrograms/ml, and titrated by step increases of 0.5 every minute until loss of conscience is obtained and BIS values are less than 50. During the maintenance phase of anesthesia propofol TCI is actively titrated to maintain BIS values between 40 and 50. If BIS is out of this range for more than 10 seconds, propofol is adjusted in 0.5 ug/mc to maintain BIS values in the predetermined limits. | Drug | Intravenous 0.9% saline infusion, Intravenous lidocaine infusion |
| Placement of arterial lineAn arterial line was placed in the anesthetised patient´s right arm by the investigator and arterial samples were obtained every 10 minutes since initiation of the study infusion to determine plasmatic lidocaine and propofol levels (if the infusion was saline the samples were not analyzed). The arterial line was removed before the end of surgery. | Procedure or surgery | Intravenous 0.9% saline infusion, Intravenous lidocaine infusion |
Primary outcome
Total propofol requirements during bispectral index guided general anesthesia
Time frame: DAY 1.
During and after elective laparoscopic cholecystectomy. Patients' anesthetic depth will be monitored during the intra-operative period using a BIS monitor. Patients' follow up considers the immediate post-operative period at the recovery room (PACU), and it will continue until patients' discharge from the hospital (average 3 days postoperatively).
1 secondary outcome
Evaluate effect of intravenous lidocaine infusion on waking time after general anesthesia
Time frame: DAY 1.
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 6 Jun 2011.
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.
Fernando R Altermatt, MD principal investigator
Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous lidocaine infusion, Propofol 1% (intravenous infusion) and Placement of arterial line in people with Intravenous Anesthetic Interaction "Unrecognized Condition", run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 6 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 6 Jun 2011. 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 Chile. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Total propofol requirements during bispectral index guided general 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 6 Jun 2011.