Best Hypnotic Drug Choice for Rapid Sequence Induction in the Operating Room

Phase 3RecruitingNCT06733129

Nantes University Hospital1,218 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,218

Conditions

Rapid Sequence Induction

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (20)

Chr Angers

Angers, France

RECRUITING

CHRU de Brest Hôpital Cavale Blanche

Brest, France

RECRUITING

Ch Louis Pasteur

Chartres, France

NOT_YET_RECRUITING

CHU Dijon

Dijon, France

RECRUITING

CHU Grenoble Alpes

Grenoble, France

NOT_YET_RECRUITING

CHD Vendée

La Roche-sur-Yon, France

RECRUITING

APHP Bicêtre

Le Kremlin-Bicêtre, France

NOT_YET_RECRUITING

CH Le Mans

Le Mans, France

RECRUITING

CHU Lille Hopital Salengro

Lille, France

RECRUITING

CHU Lille Hôpital Claude Huriez

Lille, France

RECRUITING

...and 10 more locations

Outcomes

Primary Outcomes

proportion of patients with successful intubation at first attempt and without post-induction hypotension

The main objective of the study is to compare the efficacies of ketamine alone and ketamine-propofol combination compared to standard doses of propofol to achieve successful tracheal intubation on the first attempt without hemodynamic hypotension in patients at risk of aspiration of gastric contents in the operating room. The composite primary outcome is the proportion of patients with successful intubation at first attempt and without post-induction hypotension defined by a mean arterial pressure ≤ 60 mmHg within 10 minutes after the start of the hypnotic injection.