The primary objective of this study is to evaluate whether lidocaine reduces the need of alfentanyl during colonoscopy in patients with IBD.The secondary objective of this study is to evaluate whether lidocaine reduces the incidence of respiratory…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
procedurele sedatie en analgesie (PSA)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to evaluate whether intravenously
lidocaine reduces the need for alfentanyl during colonoscopy in patients with
IBD
Secondary outcome
Incidence of hypotension (a mean arterial pressure (MAP < 60 mmHg), is
recorded as an adverse event if an intervention is performed to improve the
blood pressure.6
These interventions include administration of:
- IV Fluid
- Medications
Incidence of oxygen desaturation (<92%), is recorded as an adverse event if an
intervention is performed to improve the oxygen saturation7
These interventions include the following:
- Vigorous tactile stimulation
- Airway repositioning
- Suctioning
- Increased oxygen delivery
- Oral or nasal airway placement
- Application of positive pressure or ventilation with bag mask
Incidence of unpleasant recall of the procedure.
Postprocedural NRS
Incidence of PONV
Incidence of adverse effects of lidocaine:
light headedness, tinnitus, dizziness, blurred vision or double vision, metal
taste .
Total propofol dose
Colonoscopy time
Background summary
Colonoscopy is a commonly performed procedure to diagnose or follow up
inflammatory bowel disease (IBD) like Crohn*s disease and ulcerative colitis.
However, especially in this patient category, this can be a very uncomfortable
and painful procedure.12 Patients with IBD are known for visceral afferent
hypersensitivity caused by the chronic, recurrent, inflammatory characteristics
and has a significantly higer prevalence of narcotic alalgesic use compared
with the general population.13,17
PSA is commonly used during colonoscopy to facilitate the procedure and relieve
patient*s discomfort.14
Propofol in combination with a short-acting opioid i.e. alfentanyl is commonly
used for PSA.1 This combination during colonoscopy is associated with greater
patient satisfaction and less pain when compared with midazolam/fentanyl.4
Yet some serious adverse cardiorespiratory complications related to PSA can
occur in up to 20% of the patients, i.e. hypotension, bradycardia, and
respiratory depression.15
There is a continuous search to find alternatives, which can minimize the risk
for these adverse effects, but with equally quality of PSA.
Study objective
The primary objective of this study is to evaluate whether lidocaine reduces
the need of alfentanyl during colonoscopy in patients with IBD.
The secondary objective of this study is to evaluate whether lidocaine reduces
the incidence of respiratory depression, hypotension, PONV and postprocedural
pain
Study design
single centre double-blinded randomized placebo-controlled trial
Intervention
The intervention group receives lidocaine 1.5 mg/kg in 5 minutes followed by a
continuous infusion of 2 mg/kg/hour body weight intravenously. The placebo
group will receive saline in equivalent volumes and time
Study burden and risks
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.
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
patients with IBD, between 18 and 65 years, which are scheduled for a colonoscopy with PSA
Exclusion criteria
Pregnancy.
Emergency colonoscopy.
Known allergies for study medication
Known rhythm disorders i.e. second or third degree AV block
BMI >35
Obstructive sleep apnea syndrome
Pregnancy.
Emergency colonoscopy.
Known allergies for study medication
Known rhythm disorders i.e. second or third degree AV block
BMI >35
Obstructive sleep apnea syndrome
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-002210-46-NL |
| CCMO | NL56640.091.16 |