Plain English Summary
Background and study aims
Colonoscopy is a commonly performed procedure to diagnose or follow up an inflammatory bowel disease (IBD) like Crohn’s disease and ulcerative colitis. For some of these patients, this can be a very painful procedure. Propofol anaesthetic in combination with a short-acting opioid painkiller i.e. alfentanil is commonly used for procedural sedation and analgesia (PSA). However, alfentanil can induce some serious adverse effects like low blood pressure, slow heart rate, and slow breathing. Administration of lidocaine during an operation has a proven beneficial effect in abdominal surgery, reducing pain after operation the need for strong opiods. We expect that intravenous lidocaine will reduce the need for alfentanil during colonoscopy.
Who can participate?
Any patient who is undergoing a colonoscopy and is willing to participate in a clinical trial.
What does the study involve?
Participants in the intervention group will receive lidocaine during the normal procedure of colonoscopy. Patients who are included in the placebo group of the study will receive placebo.
What are the possible benefits and risks of participating?
All measurement and handlings to the patients which participate in this study are part of standard care. Patients will have little extra risks due to the known low and non-toxic plasma levels with this commonly used infusing regimen of lidocaine. Monitoring of patients will ensure that any potential side effect or adverse event are noticed and treated as quickly as possible.
The benefit for the patients can be that less alfentanyl needs to be given during colonoscopy, which can lead to less negative side effects like hypotension, respiratory depression and PONV.
Where is the study run from?
Radboud Universitair Medisch Centrum, Geert Grooteplein Zuid 10, Nijmegen, 625 GA, Netherlands
When is the study starting and how long is it expected to run for?
The study will run from November 2016 to November 2018.
Who is funding the study?
Radboud Universitair Medisch Centrum, Netherlands.
Who is the main contact?
Mr. Twan Aalbers, twan.aalbers@radboudumc.nl
Trial website
Contact information
Type
Public
Primary contact
Mr Twan Aalbers
ORCID ID
Contact details
Radboud Universitair Medisch Centrum
Geert Grooteplein Zuid 10
huispost 717
Nijmegen
6525 GA
Netherlands
+31243614406
twan.aalbers@radboudumc.nl
Additional identifiers
EudraCT number
2016-002210-46
ClinicalTrials.gov number
Nil known
Protocol/serial number
NL56640.091.16
Study information
Scientific title
Does intravenous lidocaine reduce the need for alfentanil during colonoscopy under procedural sedation and analgesia?
Acronym
LiSA
Study hypothesis
We hypothesize that intravenous lidocaine reduces the need for alfentanil during colonoscopy
Ethics approval
Approved 01/09/2019, Human Research Committee region Arnhem-Nijmegen (p/a Radboudumc, house post 628, P.O. box 9101, 6500 HB Nijmegen, The Netherlands; +31 24 361 3154; commissiemensgebondenonderzoek@radboudumc.nl), ref: 2016-2624
Study design
Single centre double-blinded randomized placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Healthcare domain: procedural sedation and analgesia (PSA)
Intervention
intervention: At the start of PSA, patient will receive 1.5 mg/kg intravenous bolus, followed by a continuous infusion of 2 mg/kg/h lidocaine during the colonoscopy.
Patients who are included in the placebo group of the study will receive saline in equivalent volumes and time.
At the end of the colonoscopy subjects will be monitored until they reach an Aldrete recovery score of nine or higher and for at least 30 minutes according to the local PSA protocol. Afterward, patients will be discharged. A letter with instructions is sent to the general practitioner.
All adverse events reported spontaneously by the subject of observed by the investigator or his staff will be recorded. Serious adverse events have been reported to the accredited local ethics committee.
76 patients are randomized to either intravenous lidocaine treatment or placebo by the research unit of the anesthesiology department.
The subjects were randomized into groups that resulted in equal sample sizes. There were two treatment groups (treatment medication (A) versus placebo (B)). Treatment A and B were written on pieces of paper, equal amounts of A and B. The pieces of paper were put into an envelope and blindly selected one at a time. The first paper drawn was assigned to the first patient, the second was assigned to the second subject and so on. Two research coordinators were present during this randomization process.
Intervention type
Drug
Phase
Phase IV
Drug names
Lidocaïne 1%
Primary outcome measure
Alfentanyl dose (mcg) required to maintain a score < 4 on the Facial Pain Rating Scale (Wong baker face scale) during the procedure.
Secondary outcome measures
1. Total propofol dose (mcg) required to maintain sedation level 4-5 on The Ramsey Sedation Scale during the procedure.
2. Infusion time measured in minutes from delivery to end of sedation.
3. Incidence of oxygen desaturation (defined as < 92%) measured continuously during the procedure.
4. Incidence of hypotension (defined as mean arterial pressure < 60 mmHg) measured every 5 minutes during the procedure.
5. Pain score measured using the numerical rating scale after the procedure.
6. Incidence of postprocedural nausea and vomiting measured by patient interview after the procedure.
7. Incidence of adverse effects of lidocaine (e.g. tinnitus, blurred vision or double vision, metal taste during procedure) measured by patient interview after the procedure.
Overall trial start date
09/06/2016
Overall trial end date
27/11/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Colonoscopy performed under PSA
2. Age 18-65 years
3. Inflammatory bowel disease: Crohn’s disease or ulcerative colitis
4. Informed consent
5. ASA classification 1 or 2
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
76
Total final enrolment
76
Participant exclusion criteria
1. Pregnancy
2. Emergency colonoscopy
3. Allergies for study medication
4. Rhythm disorders i.e. first, second or third degree AV block
5. Brugada syndrome
6. Cardiomyopathy
7. BMI >35
8. BMI <18
9. Obstructive sleep apnea syndrome
10. Uncontrolled hypertension
Recruitment start date
24/11/2016
Recruitment end date
13/11/2018
Locations
Countries of recruitment
Netherlands
Trial participating centre
Radboud Universitair Medisch Centrum
Geert Grooteplein Zuid 10
Nijmegen
6525 GA
Netherlands
Sponsor information
Organisation
Radboud Universitair Medisch Centrum
Sponsor details
Geert Grooteplein Zuid 10
Nijmegen
6525 GA
Netherlands
+31(0)243614406
twan.aalbers@radboudumc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Radboud Universitair Medisch Centrum
Alternative name(s)
Radboudumc, Radboud University Medical Center, Radboud University Nijmegen Medical Center, RUNMC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
Results and Publications
Publication and dissemination plan
Plans are to publish the findings of this study in a prominent magazine in the work field of anesthesiology or gastroenterology
IPD sharing statement:
The datasets generated during and the current study will be available upon request from Twan Aalbers (twan.aalbers@radboudumc.nl). Type of data: SPS datasheet. Data will become available after publication and is available until January 2034. Data will be shared in the context of scientific research. No informed consent has been given from participants. Only anonymous data is available.
Intention to publish date
01/01/2020
Participant level data
Available on request
Basic results (scientific)
See additional file ISRCTN47787339 _BasicResults_18Nov19.pdf
Publication list
Publication citations
Additional files
- ISRCTN47787339 _BasicResults_18Nov19.pdf Uploaded 29/11/2019