OBEREM: Quality Assessment of Orotracheal Intubation Without Neuromuscular Blocking Agents in Obese Patients

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Recruiting

CT.gov ID

NCT05026125

Collaborator

(none)

Enrollment

Location

Arms

17.5

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Bariatric Surgery Candidate Intubation Complication	Drug: Remifentanil Injection Drug: Remifentanil Injection plus 30%	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, randomized, controlled, double blinded and monocentric Pilot StudyProspective, randomized, controlled, double blinded and monocentric Pilot Study

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

with randomization envelopes opened by the care provider

Primary Purpose:

Treatment

Official Title:

Quality Assessment of Orotracheal Intubation Without Neuromuscular Blocking Agents in Obese Patients With Two Doses of Remifentanil: a Pilot Study

Actual Study Start Date :

Jan 13, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group control 3 μg/kg (Ideal Body Weight) of Remifentanil	Drug: Remifentanil Injection 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
Experimental: Group Active 3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil	Drug: Remifentanil Injection plus 30% 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

Arm

Intervention/Treatment

Active Comparator: Group control

3 μg/kg (Ideal Body Weight) of Remifentanil

Drug: Remifentanil Injection

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

Experimental: Group Active

3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil

Drug: Remifentanil Injection plus 30%

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

Outcome Measures

Primary Outcome Measures

percentage of good to excellent conditions of intubation [Day 0]
percentage of good to excellent conditions of intubation in obese patients using the Intubation Difficulty Scale (IDS). The IDS is graded in the operating theater during the induction of general anesthesia.

Secondary Outcome Measures

Hemodynamic events day 0 [Day 0]
Incidence rate of haemodynamic events at day 0
Hemodynamic events day 3 [Day 3]
Incidence rate of haemodynamic events at day 3
Respiratory events day 0 [day 0]
Incidence rate of respiratory events at day 0
Respiratory events day 3 [day 3]
Incidence rate of respiratory events at day 3

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient over 18 and under 60 years old.
ASA score ≤ 3
Elective bariatric surgery for patient with BMI between 35 and 60 or elective revision of a bariatric surgery for patient with a BMI over 30.
Patient with a written consent obtained with accurate information.