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Clinical trial

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

ID
Name
RC31/20/0443
Description
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.
Trial arms
Trial start
2022-01-13
Estimated PCD
2023-08-11
Trial end
2023-08-11
Status
Completed
Phase
Early phase I
Treatment
Remifentanil Injection
Injection of 3 μg/kg (Ideal Body Weight) of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery
Arms:
Group control
Other names:
orotracheal intubation, anesthesia, bariatric surgery
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
Arms:
Group Active
Other names:
orotracheal intubation, anesthesia, bariatric surgery
Size
60
Primary endpoint
percentage of good to excellent conditions of intubation
Day 0
Eligibility criteria
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. Exclusion Criteria: * Patient with risk of aspiration * Difficult airway known (Cormack score 3 ou 4). * Opioids addiction. * Alcoholism * Chronic use of Opioids * Confirmed Allergy to Propofol or Remifentanil * Severe chronic hepatic, kidney or respiratory failure * Patient already enrolled in another clinical study interfering with this study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized, controlled, double blinded and monocentric Pilot Study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'with randomization envelopes opened by the care provider', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2023-10-16

1 organization

2 products

3 indications

Organization
University Hospital of Toulouse
Product
Remifentanil
Indication
Obesity
Indication
Bariatric Surgery Candidate
Indication
Complications of Intubation
Product
Remifentanil Injection