induction phase of the general anesthesia in obese patients
Conditions
Interventions
Trade Name: rémifentanil 2mg
poudre pour solution injectable ou pour perfusion
Product Name: rémifentanil
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
Sponsors
University Hospital of Toulouse
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient 18-60 years of age. - ASA class = 3 - Patient with a BMI between 35 and 60 with indication for bariatric surgery, or BMI greater than 30 in case of bariatric surgery revision. - Patient scheduled for bariatric surgery (or repeat bariatric surgery) scheduled under general anesthesia with orotracheal intubation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: "Full stomach" patient defined by at least 1 of the following criteria: o Esophageal fibroscopy with visualized hiatal hernia. o Authenticated and treated gastroesophageal reflux. o Previously placed gastric band. - Known difficult orotracheal intubation (Cormack score = 3 (see Appendix 5)31). - Opioid or substituted drug addiction (Methadone, Buprenorphine...). - Chronic alcoholism (suspected or admitted). - Chronic treatment with an opiate. - Patient under guardianship, curatorship or under court protection. - Known hypersensitivity to propofol, sufentanil, remifentanil, soy or peanuts. - Severe renal or hepatic impairment. - Severe respiratory insufficiency. - Pregnant or breastfeeding woman. - Patient participating in another interventional research protocol that may interfere with study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate in obese subjects the quality of intubation with two dosages, after induction without curare (propofol and remifentanil) in order to have a reliable estimate of the percentage of patients with excellent intubation conditions;Secondary Objective: To evaluate in both groups the difficulty of intubation, the respiratory impact of induction, the hemodynamic impact, and the occurrence of traumatic complications related to intubation.;Primary end point(s): percentage of patients with excellent orotracheal intubation conditions;Timepoint(s) of evaluation of this end point: Day 0 Hour 0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Difficulty of orotracheal intubation o Intubation Difficulty Scale (IDS) score (Appendix 2) for complexity of endotracheal intubation28 o Percentage of patients who required re-ventilation after a failed first attempt at intubation o Percentage of patients who received an additional dose of propofol at induction o Percentage using the emergency protocol established by the study. - Respiratory impact of induction o Percentage of patients with desaturation, defined as pulse oxygen saturation below 90%. o Percentage of patients with suspected inhalation, defined as visualization of gastric fluid in the oropharynx on intubation or inhalation pneumonitis diagnosed within 48 hours of surgery. - Hemodynamic impact of induction o Percentage of patients with a drop of more than 20% in mean arterial pressure (MAP) within 40 minutes of induction. o Percentage of patients with a decrease of more than 20% in Heart Rate (HR) within 40 minutes of induction. o Number of uses of vasopressor drugs, with details of the drug administered (ephedrine, phenylephrine, norepinephrine, adrenaline, atropine). - Traumatic complications related to intubation o Percentage of patients with traumatic complications associated with intubation: dental breaks, lip and/or mouth sores, oropharyngeal bleeding, vocal cord trauma o Percentage of patients with laryngeal pain, aphonia, dysphonia postoperatively.;Timepoint(s) of evaluation of this end point: Hour H2 and Hour H48 post anesthesic induction without curare (propofol and remifentanil) | — |
Countries
France
Contacts
Public ContactDRI
University Hospital of Toulouse
Outcome results
None listed