Efficacy and safety of Remimazolam compared to Ketamine and Propofol in Rapid Sequence Induction. A monocentric pilot randomised-controlled study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Nantes

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Decision date (initial)

2026-01-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

VIATRIS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

to compare the ability of remimazolam to standard doses of propofol and ketamine to achieve successful tracheal intubation on the first attempt in patients at risk of aspiration of gastric contents in the operating room

Secondary objectives 2

1. compare the efficacy of remimazolam, propofol and ketamine: quality of intubation condition, timing of tracheal intubation, mechanical or respiratory complication, cardiovascular complications.
2. compare the tolerance of remimazolam, propofol and ketamine: episode of delirium in recovery room, episode of acute renal failure, death

Conditions and MedDRA coding

Rapid Sequence Induction in operating room

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. female and male between 18 – 80 years’ old
2. ≥ 1 risk factor of aspiration of gastric contents defined as o preoperative fasting period of less than 6 hours, o occlusive syndrome, functional ileus, vomiting episode within the last 12 hours, o orthopaedic trauma within the last 12 hours, o medical history of symptomatic gastroesophageal reflux or hiatus, hernia or gastroparesis or dysautonomia or gastroesophageal surgery with sphincter dysfunction)
3. patient requiring orotracheal intubation during general anaesthesia in the operating room
4. patient or his/her next of kin written informed consent or emergency procedure

Exclusion criteria 10

1. Refusal to participate
2. Predicted impossible tracheal intubation
3. Preoperative hemodynamic shock (MAP < 65 mmHg or under catecholamine)
4. Preoperative consciousness disorder (GCS < 12/15)
5. Preoperative respiratory distress syndrome (SpO2 < 90% in room air)
6. Contraindications to the use of remimazolam and/or ketamine and/or propofol and/or NMB: allergy to the active substance or to one of the excipients or to soy or peanuts, porphyria, intracranial hypertension, recent stroke, unstable coronary artery disease, severe heart failure, personal or family history of known malignant hyperthermia, congenital muscular dystrophy, myasthenia, a known congenital deficit in plasma pseudocholinesterase, liver failure defined as Child-Pugh classification C, uncontrolled arterial hypertension (systolic arterial pressure > 180 mmHg)
7. Pregnancy or breast-feeding woman
8. Patients under court protection or guardianship
9. Absence of insurance covering health costs
10. Patient unable to understand spoken or written French

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. proportion of patient with successful intubation at first attempt

Secondary endpoints 16

1. In the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups:median intubation quality score (IDS-3) values, median Cormack-Lehane score values and median (POGO) score values
2. In the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups: median time between start of pre-oxygenation, administration of hypnotic (start of anesthetic induction), administration of NMB, initiation of first laryngoscopy and tracheal intubation (defined as the 6th capnography curve) (minutes)
3. In the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups: median value of heart rate, mean arterial pressure, SpO2 measured every minute from pre-oxygenation during the first 5 minutes after anesthetic induction
4. n the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups: percentage of patient with pulmonary aspiration of gastric contents
5. In the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups: percentage of patient with moderate (SpO2 ≤ 95%) or severe (SpO2 ≤ 80%) desaturation during the first 5 minutes after anesthetic induction
6. In the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups: median minimal value of SpO2 value during the first 5 minutes after anesthetic induction
7. In the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups: percentage of patients with major cardio-vascular events: major hemodynamic instability defined as mean arterial pressure ≤ 60mmHg (or ≤ 40% from the patient’s reference value) [16], heart rate < 45/mn, or systolic arterial pressure < 80 mmHg, cardiac arrythmia requiring pharmacological or external electric intervention or lasting more than 30 seconds
8. In the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups: percentage of patients with anaphylaxis reaction (Grade of anaphylaxis reaction)
9. In the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups: rates of vasopressor use and volume of intravenous fluids for vascular filling (from entry into the operating theatre to induction and from induction to recovery room)
10. In the operating theatre (within 5 minutes after induction of anesthesia) compared between the three study groups: the total dose of hypnotic used during the first 5 minutes after anesthetic induction
11. In the recovery room compared between the three study groups: postoperative Nu-DESC score median value
12. In the recovery room compared between the three study groups: percentage of patient requiring sedative therapy in recovery room assigned with delirium
13. Up to day 7 compared between the 3 groups: percentage of patient with major cardiovascular complications
14. Up to day 7 compared between the three study groups: percentage of patient with postoperative acute renal failure at day 7
15. Up to day 7 compared between the three study groups:intra-hospital mortality
16. Up to day 7 compared between the three study groups: survival proportion at day 7

Investigational products

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

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nantes

Sponsor organisation

Centre Hospitalier Universitaire De Nantes

Address

1 Place Alexis Ricordeau

City

Nantes

Postcode

44000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Nantes

Contact name

Raphaël CINOTTI

Public contact point

Organisation

Centre Hospitalier Universitaire De Nantes

Contact name

Raphaël CINOTTI

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

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

Documents 12 files

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

Application history

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