Condition category
Surgery
Date applied
06/02/2019
Date assigned
25/02/2019
Last edited
18/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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

www.radboudumc.nl

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 current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

01/01/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes