Hospital University of Toulouse
Toulouse, France
NCT Number: NCT05026125
This study will assess the condition of orotracheal intubation in obese patients undergoing an elective bariatric surgery without the use of neuromuscular blocking agents.
During the induction of general anesthesia, Propofol - Remifentanil combination will be used.
The patients will be randomized in 2 groups with different doses of Remifentanil.
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Phase 4
Toulouse, France
The prevalence of obesity increases steadily. For anesthesiologists, the airway management of obese patients is known to be difficult and at risk. Tracheal intubation needs to be successful quickly. Neuromuscular blocking agents allow this option but with a risk of anaphylaxis and respiratory complications. In fact, for many surgical procedures those drugs are not necessary.
Numerous studies in non-obese patients with the combination of Remifentanil and Propofol have shown adequate conditions for tracheal intubation without neuromuscular blocking drugs. This combination has never been studied in obese patient.
After randomization, induction of general anesthesia will be performed with 2,5 mg/kg of Propofol in association with either 3 µg/kg of Ideal Body Weight of Remifentanil, or 3 µg/kg + 30% of Ideal Body Weight of Remifentanil.
Minutes after the induction, orotracheal intubation will be performed, and the Intubation Difficulty Scale recorded.
Other data on hemodynamic, respiratory and airway management will be are collected during the surgery.
In the Post Anaesthetic Care Unit (PACU),Any symptoms of traumatic airway management or aspiration are collected.
Those data will be again looked for and collected on the day of the patient's discharge.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Injection of 3 μg/kg (Ideal Body Weight) of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery
Other names: orotracheal intubation, anesthesia, bariatric surgery
Injection of 3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery
Other names: orotracheal intubation, anesthesia, bariatric surgery
Time frame: Baseline
Intubation conditions will be assessed using the intubation conditions score proposed by Viby-Mogensen and al. (Scandinavian score). The score defines intubation conditions: excellent (all variables are excellent), good (all variables are either excellent or good), or poor (presence of a poor variable).
Time frame: Baseline
Percentage of patients with arterial hypotension (>20% decrease in mean arterial pressure) within 40 minutes of intubation
Time frame: Baseline
Percentage of patients with bradycardia (>20% decrease in heart rate) within 40 minutes after intubation
Time frame: Baseline
Number of times vasopressor drugs were used.after intubation
Time frame: Baseline
Percentage of patients with desaturation (pulse oximetry (SpO2) below 90%.)
Time frame: From Baseline to day 2
Percentage of patients with aspiration (defined by the existence of gastric fluid in the oropharynx during direct laryngoscopy or by the diagnosis of pneumopathy within 48 hours of surgery).
Time frame: Baseline
Intubation complexity Measured by Difficult intubation score (IDS): scale from 0 (easy) to >5 (very difficult)
Time frame: Baseline
Intubation difficulties Measured by Cormack-Lehane classification (from 1: easy to 4 difficult)
Time frame: Baseline
Intubation difficulties measured by percentage of use of the study's emergency
Time frame: Baseline
Percentage of patients with an anatomical lesion (dental fracture, lip or mouth wound, oropharyngeal haemorrhage, vocal cord trauma)
Time frame: Day 2
Percentage of patients with postoperative functional discomfort (laryngeal pain, aphonia or dysphonia).
University Hospital, Toulouse
Other
Quality Assessment of Orotracheal Intubation Without Neuromuscular Blocking Agents in Obese Patients with Two Doses of Remifentanil: a Pilot Study
Acronym: OBEREM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03556995
Bariatric Surgery Candidate, Bleeding
Tel Aviv, Israel
View Trial DetailsNCT03617185
Bariatric Surgery Candidate, Behavior
Ann Arbor, Michigan, United States
View Trial DetailsNCT06592313
Bariatric Surgery Candidate, Body Weight
Tijuana, Estado de Baja California, Mexico
View Trial DetailsNCT03620773
Adolescent Obesity, Bariatric Surgery Candidate
Aurora, Colorado, United States
View Trial Details