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MIDAZOLAM/FENTANYL, PROPOFOL/ALFENTANIL OR ALFENTANIL ONLY FOR COLONOSCOPY
7
INTRODUCTION
The number of colonoscopies has grown considerably (64%) in recent years,
1
and it will
continue to rise in the next years.
2
Most colonoscopies are performed under conscious or deep sedation. Sedation has
traditionally been provided by gastroenterologists and is typically achieved with
benzodiazepines. However, benzodiazepines often do not provide sufficient patient
comfort during painful interventions.
3
Therefore, opioids are often added. This combination
prolongs the duration of the sedative effect, resulting in delayed discharge.
4
Nonetheless,
this sedation regimen is still frequently used.
5
An important step in the evolution of procedural sedation was the introduction of propofol.
Propofol, with its fast on- andoffset of action and its high level of satisfaction achieved among
gastroenterologists and patients, seems an ideal choice for endoscopic interventions.
6
The most serious disadvantage, however, of propofol sedation is the risk to progress from
moderate to deep sedation with consecutive airway compromise and cardiopulmonary
depression.
7
Therefore, its application in the US still is limited to anaesthesia providers.
That’s why, anaesthesia professional participation in endoscopic procedures is expected to
grow from 23% in 2007 to 53.4% in 2015 (United States).
8
The aim of our study was to find
an alternative regime facilitating sedation for colonoscopy in a satisfactory and safe manner
for patients and endoscopists in a teaching hospital.
Alfentanil could be such an alternative. Alfentanil provides analgesia and leads to mild
sedation with the patient still able to communicate. Moreover, all actions of alfentanil can be
immediately reversed by naloxone, making it safer in the hands of non-anaesthesiologists.
MATERIALS AND METHODS
The ethics committee of the Academic Medical Centre (AMC), Amsterdam, approved the
protocol for this prospective randomised controlled trial (NL 31863), EudraCT 2010-020502-
15, and ISRCTN Register: ISRCTN 83950185).
In the AMC, colonoscopies are routine procedures performed at different intervention
sites of the Department of Gastroenterology. Randomly, we selected 55 colonoscopy days
within a 5-month period at one of our three colonoscopy suites. Four hundred and eight
patients were eligible. Due to overlap in time between the procedures, 242 patients were
asked for participation, 62 patients refused, and after providing written informed consent,
the eligible patients (n=180) were randomised per working day to one of the following
study arms: midazolam/fentanyl (group M, n=60), alfentanil (group A, n=60), and propofol/
alfentanil (group P, n=60).
Patients were blinded to the sedation regimen. Sedation was either performed by a
gastroenterology nurse (without anaesthesia personnel participation), or by an anaesthesia