

145
A RANDOMISED CONTROLLED MULTICENTRE TRIAL
11
At the recovery room, monitoring is limited to SpO
2
, RR, ECG, NIBP, and Aldrete score
7
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.