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

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
Chr Angers
RECRUITING
Angers
CHRU de Brest Hôpital Cavale Blanche
RECRUITING
Brest
Ch Louis Pasteur
NOT_YET_RECRUITING
Chartres
CHU Dijon
RECRUITING
Dijon
CHU Grenoble Alpes
NOT_YET_RECRUITING
Grenoble
CHD Vendée
RECRUITING
La Roche-sur-yon
APHP Bicêtre
NOT_YET_RECRUITING
Le Kremlin-bicêtre
CH Le Mans
RECRUITING
Le Mans
CHU Lille Hôpital Claude Huriez
RECRUITING
Lille
CHU Lille Hopital Salengro
RECRUITING
Lille
CHU Lyon Hôpital Sud
NOT_YET_RECRUITING
Lyon
HCL Lyon Croix-Rousse
NOT_YET_RECRUITING
Lyon
Chu Nantes
RECRUITING
Nantes
Chu Nantes (Laennec)
RECRUITING
Nantes
APHP St-Antoine
NOT_YET_RECRUITING
Paris
APHP Tenon
NOT_YET_RECRUITING
Paris
CHU Poitiers
RECRUITING
Poitiers
Hopital Foch
RECRUITING
Suresnes
CHU Toulouse Hôpital Purpan
NOT_YET_RECRUITING
Toulouse
CHU Toulouse Hôpital Rangueil
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Nicolas GRILLOT, MD
nicolas.grillot@chu-nantes.fr
02 53 48 22 24
Time Frame
Start Date: 2025-04-14
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 1218
Treatments
Experimental: KETOFOL
Ketofol: combination of Ketamine and Propofol : consecutive direct IV injection of Ketamine 1 mg/kg and Propofol 1 mg/kg after completing pre-oxygenation
Experimental: KETAMINE
direct IV injection at dosage of 2 mg/kg after completing pre-oxygenation
Active_comparator: PROPOFOL
direct IV injection at dosage of 2 mg/kg after completing pre-oxygenation.
Related Therapeutic Areas
Sponsors
Leads: Nantes University Hospital

This content was sourced from clinicaltrials.gov