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ClinicalTrials.gov ID

NCT06733129

Lead Sponsor

Nantes University HospitalOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

1,218Estimated

Last Update Posted

Dec 2, 2025Actual

Start Date

Apr 14, 2025Actual

Primary Completion Date

Apr 14, 2027Estimated

Completion Date

Apr 30, 2027Estimated

Official Title

Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room: a 3-arm Randomized Trial

Brief Summary

The best hypnotic choice to optimize the balance between good intubation condition quality and hemodynamic stability during RSI performed in the operating theatre remained to be investigated.

Therefore, a randomized study evaluating the efficacy of propofol, ketamine, and a combination of both is appropriate. So, we designed the HyPnotiKs randomized controlled study to investigate the efficacy of these hypnotic drugs in patients undergoing RSI in the operating theatre. The primary endpoint will be the successful tracheal intubation at the first attempt without major arterial hypotension event.

• Rapid Sequence Induction

• direct IV injection
• combination of Ketamine and Propofol

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• age between 18 - 80 years' old

• female* and male

  • ≥ 1 risk factor of aspiration of gastric contents defined as
  • preoperative fasting period of less than 6 hours,
  • occlusive syndrome, functional ileus, vomiting episode within the last 12 hours,
  • orthopaedic trauma within the last 12 hours,
  • medical history of symptomatic gastroesophageal reflux or hiatus, hernia or gastroparesis or dysautonomia or gastroesophageal surgery with sphincter dysfunction)

• patient requiring orotracheal intubation during general anaesthesia in the operating room.

• patient or his/her next of kin written informed consent or emergency procedure

• failure to discontinue GLP1 analogue as recommended (exenatide, liraglutide, albiglutide, taspoglutide, lixisenatide)

Exclusion Criteria:

• predicted impossible tracheal intubation (≥ 1 of the following criteria: patient with known intubation complications, Mallampati score IV, Thyromental Distance ≤ 4.0 cm, Mouth Opening < 3 cm, Sternomental Distance < 12.5 cm, significant modification of the airway due to congenital, cancer, trauma or burning lesions (non-exhaustive list)) [30]

• preoperative arterial hypotension (MAP < 65 mmHg or under catecholamine)

• preoperative respiratory distress syndrome (SpO2 < 90% in room air)

• contraindications to the use of 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
  • uncontrolled arterial hypertension (systolic arterial pressure > 180 mmHg)
  • personal or family history of known malignant hyperthermia, congenital muscular dystrophy, myasthenia, a known congenital deficit in plasma pseudocholinesterase

• pregnancy or breast-feeding woman

• patients under court protection or guardianship

• absence of insurance covering health costs

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Nantes University HospitalOTHER

guinotpierregregoire@gmail.com03 80 28 15 54 ext. +33

lblanchet@ch-lemans.fr02 43 43 28 40 ext. +33

franck.verdonk@aphp.fr01 71 97 70 70 ext. +33

quentin.saint-genis@chu-poitiers.fr05 49 44 38 95 ext. +33