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145

A RANDOMISED CONTROLLED MULTICENTRE TRIAL

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At the recovery room, monitoring is limited to SpO

2

, RR, ECG, NIBP, and Aldrete score

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every 15 minutes. This score describes the patient’s motoric activity, mechanical respiratory

function, oxygen saturation, blood pressure, and consciousness and is designed to assess

patient recovery after sedation. The total score is 10.

During the time in the recovery room, patients have to complete the identical questionnaire

as they completed at baseline concerning pain, drowsiness, nausea, perception, and mood

using VAS scales (0-100). Following daily standards, post-procedural pain is mentioned as

VAS > 40 and is treated with 2 mg morphine intravenously, nausea with a VAS > 40 will be

treated with 4 mg ondansetron intravenously.

Patients have to stay for at least 1 hour in the recovery room. “Ready for discharge” is

declared when an Aldrete Score ≥ 9 is met, and the patient is awake with stable vital signs,

able to walk around, and without nausea or dizziness.

On the next day, a follow-up telephone call will take place.

Primary objective

Definition of primary objective

Primary objective of this study - reflecting the effectiveness of coadministration of propofol

and esketamine - is the total dose of propofol used during the procedure.

Assessment of primary objective

The total amount of propofol, esketamine, and alfentanil will be noted.

Secondary objectives

Definition of secondary objectives

Secondary endpoints focus on satisfaction of patients and endoscopist with sedation, the

side effects of sedation, and on haemodynamic stability and safety - being reflected in the

number of respiratory and cardiovascular events.

Assessment of secondary objectives

Pain, sedation level, and side effects as nausea and psychotomimetic effects are recorded

on questionnaires that patients have to fill in before and after the procedure. To assess post-

procedural satisfaction, patients are contacted the day after the procedure by telephone. In

addition, endoscopists’ experiences with sedation are recorded on a questionnaire directly

after the procedure.