Susanne Eberl

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A RANDOMISED CONTROLLED MULTICENTRE TRIAL

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Seizure disorders

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Increased intracranial pressure

The schedule of enrolment, intervention, and assessment is reported according to the

SPIRIT statement.

Consent

Patients´ medical history and their current state of health are screened on paper during

standard anaesthetic preassessment before the scheduled sedation. The investigator

uses the anaesthetic preassessment form to screen patients for in- and exclusion criteria.

Patients meeting inclusion criteria are contacted by phone to verify criteria and asked for

their willingness to participate in this study. If they agree to participate, further information

is send by mail. Final inclusion occurs after written informed consent at the day of the

procedure.

If patients deny taking part in the study, they are sedated according to the AMC standards

with propofol and alfentanil.

Randomisation

Patients are randomised online in both centres after signing informed consent using

the ALEA software program provided by the Clinical Research Unit (CRU) of the AMC for

centralised randomisation in clinical trial. Patients are allocated to a treatment arm after the

anaesthetic nurse has entered patient details and absence of exclusion criteria in the ALEA

program.

The study is performed as a single blinded study. Because of safety reasons the anaesthetic

nurse is not be blinded to the treatment arm and will therefore perform the randomisation

in the ALEA program. The patient, endoscopist, and investigator are blinded to the allocated

treatment arm.

Patient data are collected on CRFs in each centre. Data processing will take place in the

AMC using Castor database and will be performed by the investigator or study coordinator.

The CRU also will monitor independently all side locations of the trial three times using

duplicated measurements documented in the hospital data management systems with

complete access to all databases.

Intervention

All patients are fasted at least 6 hours before ERCP. Antibiotic prophylaxis is given according

to hospital standards. As a standard procedure, diclofenac 100 mg is administered rectally

immediately before procedure to reduce post ERCP pancreatitis.

Procedural sedation is

performed by anaesthesia nurses trained in the standards of care for procedural sedation