Remimazolam versus propofol for deep sedation during Endoscopic Ultrasound (EUS) procedures. A randomized controlled trial.

2025-521784-12-00 Protocol RESPONSE Therapeutic use (Phase IV) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol RESPONSE

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Authorised, recruitment pending
Participants planned 332
Countries 1
Sites 1

Gastric and pancreatic cancer

To compare a remimazolam-based sedation regimen managed by endoscopists to a propofol-based sedation regimen performed by anesthesiologists during EUS gastrointestinal procedures.

Key facts

Sponsor
Ospedale San Raffaele S.r.l.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04], Diseases [C] - Digestive System Diseases [C06]
Decision date (initial)
2025-11-11
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No
Funding sources
Viatris Italia S.r.l.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To compare a remimazolam-based sedation regimen managed by endoscopists to a propofol-based sedation regimen performed by anesthesiologists during EUS gastrointestinal procedures.

Secondary objectives 2

  1. To compare between the two groups procedural time and quality of sedation.
  2. Cost effectiveness analysis

Conditions and MedDRA coding

Gastric and pancreatic cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Patients >18 years
  2. Patients scheduled for elective EUS gastrointestinal procedures
  3. Signed informed consent
  4. Outpatient procedures

Exclusion criteria 7

  1. Patients < 18 years
  2. Patients scheduled for urgent EUS gastrointestinal procedures
  3. Known contraindications to the use of propofol and/or remimazolam
  4. Patient’s refusal to participate
  5. Procedures that require orotracheal intubation
  6. Pregnant and breastfeeding women
  7. Inpatient procedures

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 7

  1. The primary outcome will be a composite outcome of cardiorespiratory adverse events
  2. Oxygen desaturation, defined as SpO2 < 90% or need to increase the basal oxygen flow.
  3. Respiratory depression (desaturation requiring interventions as chin-stiff, bag mask ventilation)
  4. Hypotension (mean arterial pressure < 65 mmHg or 20% drop in systolic blood pressure from preprocedural values)
  5. Arrhythmia
  6. Tachycardia (HR > 100 beats for minute or a 25% increase from baseline HR) or bradycardia (<50 beats for minute)
  7. Need for intervention of anesthesiologist (according to the evaluation of endoscopist).

Secondary endpoints 11

  1. Evaluation of the quality of sedation, through specific questions (according to patients ‘and endoscopist’s point of view)
  2. Time needed to start the procedure
  3. Awakening time
  4. Time spent in recovery room
  5. Time for hospital discharge
  6. Pain at injection
  7. Need for hospital admission
  8. Need to crossover to other arm
  9. Need for advanced respiratory support (tracheal intubation)
  10. Need to use additional hypnotic drugs
  11. A cost-effectiveness analysis will be also performed considering costs related to used drugs, employment of personnel and occupation time of endoscopy and recovery room. We will also record all the other drugs used during and after sedation, the time to wake up after sedation (endoscopy room occupancy time) and the time to hospital discharge (recovery room occupancy time).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Remimazolam

SCP52642089 · ATC

Active substance
Remimazolam
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
33 mg milligram(s)
Max total dose
33 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
N05CD14 — REMIMAZOLAM
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 1

Propofol

SCP12667971 · ATC

Active substance
Propofol
Substance synonyms
2,6-Bis(PROPAN-2-YL)PHENOL, ICI-35868, DISOPROFOL
Route of administration
INTRAVENOUS INFUSION
Max daily dose
6 mg/kg/h milligram(s)/kilogram/hour
Max total dose
6 mg/kg/h milligram(s)/kilogram/hour
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
N01AX10 — PROPOFOL
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Ospedale San Raffaele S.r.l.

31 Total trials 12 Recruiting 11 Ended
Academic / Non-commercial
Sponsor organisation
Ospedale San Raffaele S.r.l.
Address
Via Olgettina 60
City
Milan
Postcode
20132
Country
Italy

Scientific contact point

Organisation
Ospedale San Raffaele S.r.l.
Contact name
Stefano Turi

Public contact point

Organisation
Ospedale San Raffaele S.r.l.
Contact name
Stefano Turi

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Italy Authorised, recruitment pending 332 1
Rest of world — 0 —

Investigational sites

Italy

1 site · Authorised, recruitment pending
Ospedale San Raffaele S.r.l.
Anesthesia and Intensive Care, Via Olgettina 60, 20132, Milan

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2025-521784-12-00_signed_redacted 1.2
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Subject information and informed consent form (for publication) L1_ICF adults _redacted 1.1
Subject information and informed consent form (for publication) L1_SIS adults_Privacy_redacted 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_GP letter_redacted 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Propofol 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Remimazolam 1
Synopsis of the protocol (for publication) D1_Protocol synopsis EN 2025-521784-12-00 1.2
Synopsis of the protocol (for publication) D1_Protocol synopsis IT 2025-521784-12-00 1.2
Synopsis of the protocol (for publication) D1_Protocol synopsis IT 2025-521784-12-00 1.2
Synopsis of the protocol (for publication) D4_Patient facing documents_Patient ID Card 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-07-25 Italy Acceptable
2025-11-10
 2025-11-11

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