ColonoscopyPhase 4NCT02784860
Effects of Intravenous Lidocaine During Sedation for Colonoscopy.
A Phase 4 study testing Lidocaine and normal saline in people with Colonoscopy, run by University of Liege at 1 site in Belgium.
Trial summary
This study assesses the benefits of continuous intravenous lidocaine administration during sedation for colonoscopy. Sedation will consist of propofol infusion titrated to provide adequate working conditions to the gastroenterologist. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Lidocaine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2016to Oct 2016
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- colonoscopy without gastroscopy
Who cannot join
- lidocaine allergy
- epilepsy
- severe heart rhythm disorders
- renal failure with creatinine clearance lower than 30ml/minute
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Intravenous Lidocaine Infusion During Sedation for Colonoscopy
This study assesses the benefits of continuous intravenous lidocaine administration during sedation for colonoscopy.
Sedation will consist of propofol infusion titrated to provide adequate working conditions to the gastroenterologist. Patients will be randomly allocated into two groups: lidocaine infusion (bolus of 1.5 mg/kg followed by a continuous infusion of 4 mg/kg/h) or the same volume of placebo (normal saline)
Read the detailed description
The potential benefits of lidocaine infusion will be tested on:
- propofol consumption (primary outcome)
- intraoperative respiratory depression
- time for patient recovery
- postoperative fatigue
- postoperative pain
- postoperative cognitive dysfunction
- Conditions
- Colonoscopy
- Being tested
- Lidocaine, normal saline
- Keywords
- colonoscopy, lidocaine, propofol, sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called XYLOCAINE ; (NDA) 006488
Propofol (0.5 mg/kg or more) is titrated to provide loss of consciousness. Then in the lidocaine group, lidocaine 2% is administered as a bolus followed by a continuous intravenous infusion after loss of consciousness
normal salineDrug
Propofol (0.5 mg/kg or more) is titrated to provide loss of consciousness. Then in the placebo group, the same volume of normal saline is administered after loss of consciousness
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Lidocaine. Administration of lidocaine is started with 1.5 mg/kg bolus injection followed by a continuous infusion of 4mg/kg/h. Receives: Drug: Lidocaine |
| Placebo | Placebo comparator | Placebo Administration of normal saline: same volume of saline as lidocaine. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of propofol
Dose of propofol administered during sedation if measured at the end of it.
Measured: intraoperative
Secondary outcomes (6)
Episodes of oxygen desaturation
Episodes of oxygen desaturation: SpO2 < 95 and 90%
Measured: intraoperative
Time for recovery
the patient is discharged when conscious and able to give his birth date
Measured: intraoperative
Quality of working conditions assessed by the gastroenterologist
Measured: intraoperative
Abdominal discomfort
Evaluation with VAS (visual analog scale) form 0 (no discomfort) to 10 (unbearable Abdominal discomfort assessed on a 0 to 10 visual analog scale
Measured: intraoperative and 15 minutes later
Postoperative fatigue
Fatigue will be assessed on a visual analog scale
Measured: 15 min after sedation
Cognitive condition
Cognitive condition will be evaluated with the MMSE (Minimal Mental State Examination)
Measured: 15 minutes after sedation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016
- Study completionOct 2016
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 ColonoscopyStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean François Brichant, University of Liege
- Investigators
- Jean Joris, MD, Principal investigator, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784860
- Sponsor's protocol ID
- LIDOCOLO2016JJCF
- Status last verified
- Dec 2017
- First submitted
- 2 May 2016
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Forster C, Vanhaudenhuyse A, Gast P, Louis E, Hick G, Brichant JF, Joris J. Intravenous infusion of lidocaine significantly reduces propofol dose for colonoscopy: a randomised placebo-controlled study. Br J Anaesth. 2018 Nov;121(5):1059-1064. doi: 10.1016/j.bja.2018.06.019. Epub 2018 Aug 1.
PubMed 30336850
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Intravenous Lidocaine Infusion During Sedation for Colonoscopy
- ClinicalTrials.gov ID
- NCT02784860
- Acronym / sponsor ID
- LIDOCOLO2016JJCF
- Conditions
- Colonoscopy
- Keywords
- colonoscopy, lidocaine, propofol, sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 27 May 2016 (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.
This study assesses the benefits of continuous intravenous lidocaine administration during sedation for colonoscopy.
Sedation will consist of propofol infusion titrated to provide adequate working conditions to the gastroenterologist. Patients will be randomly allocated into two groups: lidocaine infusion (bolus of 1.5 mg/kg followed by a continuous infusion of 4 mg/kg/h) or the same volume of placebo (normal saline)
Detailed description
The potential benefits of lidocaine infusion will be tested on:
- propofol consumption (primary outcome)
- intraoperative respiratory depression
- time for patient recovery
- postoperative fatigue
- postoperative pain
- postoperative cognitive dysfunction
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: LidocaineLidocaine. Administration of lidocaine is started with 1.5 mg/kg bolus injection followed by a continuous infusion of 4mg/kg/h. |
| Placebo | Placebo comparator | Drug: normal salinePlacebo Administration of normal saline: same volume of saline as lidocaine. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- colonoscopy without gastroscopy
Key exclusion criteria (4 listed)
- lidocaine allergy
- epilepsy
- severe heart rhythm disorders
- renal failure with creatinine clearance lower than 30ml/minute
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 |
|---|---|---|
| LidocaineAlso: XYLOCAINE ; (NDA) 006488Propofol (0.5 mg/kg or more) is titrated to provide loss of consciousness. Then in the lidocaine group, lidocaine 2% is administered as a bolus followed by a continuous intravenous infusion after loss of consciousness | Drug | Lidocaine |
| normal salinePropofol (0.5 mg/kg or more) is titrated to provide loss of consciousness. Then in the placebo group, the same volume of normal saline is administered after loss of consciousness | Drug | Placebo |
Primary outcome
Consumption of propofol
Time frame: intraoperative
Dose of propofol administered during sedation if measured at the end of it.
6 secondary outcomes
Episodes of oxygen desaturation
Time frame: intraoperative
Time for recovery
Time frame: intraoperative
Quality of working conditions assessed by the gastroenterologist
Time frame: intraoperative
Abdominal discomfort
Time frame: intraoperative and 15 minutes later
Postoperative fatigue
Time frame: 15 min after sedation
Cognitive condition
Time frame: 15 minutes after sedation
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 Jan 2018.
- Derived from this study: PubMed 30336850Forster C, Vanhaudenhuyse A, Gast P, Louis E, Hick G, Brichant JF, Joris J. Intravenous infusion of lidocaine significantly reduces propofol dose for colonoscopy: a randomised placebo-controlled study. Br J Anaesth. 2018 Nov;121(5):1059-1064. doi: 10.1016/j.bja.2018.06.019. Epub 2018 Aug 1.
- 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.
Jean Joris, MD principal investigator
University of Liege
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 Lidocaine and normal saline in people with Colonoscopy, run by University of Liege at 1 site in Belgium.
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 4 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 Jan 2018. 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 Belgium. 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?
Consumption of propofol (time frame: intraoperative). 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 NCT02784860, 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 3 Jan 2018.