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Chapter 11
Trial design
This trial is designed as a prospective randomised controlled multicentre study. It will
be reported following the SPIRIT statement.
4
Sponsor of this trial is the Department of
Anaesthesiology of the Academic Medical Centre (AMC) in Amsterdam. The sponsor is
responsible for the collection, management, analysis, and interpretation of data; writing of
the report; and the decision to submit the report for publication.
Participants
Number of patients’ needed
Primary objective is the total dosage of propofol. Sample size calculation is based on
retrospectively obtained propofol data from previous ERCPs, collected in our hospital
sedation database. The mean (+ standard deviation) dosage of propofol during ERCP`s was
580+190 mg. Therefore, we will have to study 76 patients in each group, given a power of
0.80 and a type I error of 0.05 to reduce the amount of propofol by 15%. With a dropout rate
of 10 % the estimated sample size will be 166 patients.
Eligibility
The study takes place at the Department of Gastroenterology and Hepatology in the
Academic Medical Centre (AMC), Amsterdam and the Department of Gastroenterology
and Hepatology in the Tjongerschans hospital, Heerenveen, the Netherlands, beginning
December 2015 to January 2018. Eligible patients for participation in this clinical trial are
those scheduled for elective ERCP under deep propofol sedation, > 18 years, and with ASA
physical state I-III, with written informed consent.
Exclusion criteria
Patient are excluded, if the following criteria in the patients’ anamnesis are applicable:
•
Age range < 18 years
•
ASA IV and V
•
Known allergy to planned medication
•
History of unregulated or malignant hypertension
•
Significant ischaemic heart disease
•
History of psychological problems or psychiatric disease
•
Use of drugs that affect the central nervous system
•
Substance abuse
•
Chronic pain
•
Pregnancy