Comparison of Remifentanil With a Combination of Remimazolam and Dexmedetomidine for Awake Tracheal Intubation
NCT Number: NCT06581731
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Difficult or Failed Intubation|Sedative Adverse Reaction
Interventions: DRUG: Midazolam
Sponsor: Nanjing First Hospital, Nanjing Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2024-10-20
Completion Date: 2025-10-10

Summary:
Awake fiberoptic intubation (AFOI) requires airway surface anesthesia to inhibit pharyngeal reflex, glottis closure reflex, and cough reflex. Additionally, the use of sedative drugs can enhance patient comfort and tolerance, reduce anxiety, and eliminate harmful effects on systemic hemodynamics.Remifentanil is a rapid-onset, short-acting opioid analgesic that does not rely on liver or kidney function for metabolism. As the first ultra-short-acting opioid drug in clinical use, its effects are not significantly related to infusion time or dose. It provides sufficient analgesia and good anesthetic control for patients undergoing awake intubation in difficult airway situations.Remimazolam is an esterified metabolite of the benzodiazepine midazolam. It has a rapid onset, short duration of sedation, and quick recovery time, with a half-life of 5-10 minutes. Additionally, remimazolam does not affect heart rate, electrocardiogram, blood pressure, or respiratory rate. It rarely accumulates after prolonged infusion and does not impact liver or kidney function. Studies suggest that a combination of benzodiazepines and opioids may be an ideal choice for Awake Fiberoptic Intubation (AFOI)Dexmedetomidine is a highly selective α2-adrenergic agonist that produces dose-dependent sedative and anxiolytic effects, with some degree of analgesia. It can preserve airway reflexes, relax bronchial smooth muscle, and suppress coughing without causing respiratory depression. However, it may lead to bradycardia, cardiac conduction block, and hypotension, and its onset of action can be slow when used alone.Therefore, the objective of this study is to compare the safety and efficacy of remifentanil alone versus a combination of dexmedetomidine and remifentanil for sedation during conscious tracheal intubation

Primary Outcome Measures: intubation scores, Perform a four-level scoring based on vocal cord movement (open, movement, closed), cough intensity (none, mild, moderate, severe), and limb movement (none, mild, moderate, severe)., preoperative|intubation comfort scores, patient tolerance was assessed by intubation comfort scores (1, no reaction, no change or a single change in the facial expression; 2, slight reaction, grimacing facial expressions; 3, moderate reaction, severe facial grimace but retained ability to follow verbal command and no reflex head movements; 4 severe reaction, severe facial grimace associated with head movements, but patient remains able to obey verbal commands; 5, very severe reaction, severe facial grimace associated with protective head and limb movements hindering the procedure and an inability to obey any verbal command; 6, uncooperative), preoperative
Secondary Outcome Measures: hypoxia, SPO2\<90%, intraoperative|occurrence of adverse reactions other than hypoxia, hypertension, hypotension, tachycardia, bradycardia, intraoperative|clinical outcome immediately following the AFOI, 1, cooperative; 2, restless with minimal resistance; 3, severe resistance with immediate application of general anesthesia, intraoperative|recall of the AFOI, 1 = none, 2 = partial, and 3 = full, after surgery, up to 24h|satisfaction score of the AFOI, 1 = none, 2 = mild, 3 = moderate, and 4 = severe, after surgery, up to 24h