A Prospective Comparative Study Between Dexmedetomidine And Remifentanil For Sedation In Awake Fibreoptic Nasotracheal Intubation
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- MS Ramaiah Medical College
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- first attempt success rate and quality of intubation
Overview
Brief Summary
The Difficult Airway Society (DAS) recommends considering awake fiberoptic nasotracheal intubation (AFONTI) for patients with a predicted difficult airway as they are at risk of complications during airway management under general anaesthesia. The core principles of AFONTI include maintaining oxygenation, ensuring adequate topical anaesthesia of the airway, performing the procedure efficiently, and, when necessary, using sedation as majority of the patients are uncooperative. AFONTI performed in the absence of a sedative is extremely uncomfortable, calling for the need of controlled sedation.
Sedation used cautiously can help reduce anxiety and discomfort, provide amnesia, and enhance procedural tolerance. The ideal sedative should be short-acting, easy to titrate, and provide adequate sedation with amnesia while ensuring spontaneous ventilation by reducing the patient’s airway reflex response like coughing and laryngospasm. Controlled sedation maintains physiological hemodynamic parameters thereby guaranteeing patient cooperation and comfort. However, sedation also carries risks such as airway obstruction, oxygen desaturation, and cardiovascular instability. Therefore, careful selection of drug regimens is crucial to ensure safe and effective AFONTI. The most commonly used sedatives for this setting include benzodiazepines, ketamine, propofol, sevoflurane, dexmedetomidine, and remifentanil.
Dexmedetomidine (D), a selective alpha 2 adrenergic G protein coupled receptor agonist, acting on the postsynaptic alpha 2 receptors in the locus coeruleus attributing its sedative, anxiolytic, amnestic and sympatholytic properties. D also influences the release of substance P from dorsal horn of spinal cord attributing its analgesic properties. D has a short distribution half-life of 6 minutes and a terminal elimination half life of 2 hours.
Remifentanil (R) is an ultra-short-acting opioid with selective mu receptor agonist properties, offering sedative, strong analgesic effects and antitussive properties. R has rapid onset and redistribution half-life of 3 minutes as it is metabolized by non-specific plasma esterases and elimination half-life of 6 minutes ensuring quick recovery and attenuation of stress responses allowing easier patient communication. Pharmacokinetics of R vary with age and lean body mass while pharmacodynamics varies only with age.
In this study, which is a randomized control trial with a sample size of 50 that will be conducted in MS Ramaiah Medical College, Bangalore, we aim to compare the effectiveness of Dexmedetomidine and Remifentanil as sole sedative agents for AFONTI with the hypothesis that Remifentanil with its higher analgesic efficacy and anti-tussive property, may provide more favourable intubation conditions yielding higher first attempt success rates.
The primary outcome will be the first attempt success rate and quality of intubation assessed by a 5 point intubation score depicted by 1for No movement, 2 for Grimacing, 3 for Mild cough , 4 for Major limb movement and 5 for Prolonged coughing.
The secondary outcome will be based on,
• Time required to achieve a Ramsay Sedation Score (RSS) of 2 with RSS ranging from 1 to 6 depicted by 1 for Patient is anxious, agitated, or restless, 2 for Patient is cooperative, oriented, and tranquil, 3 for Patient responds to commands only, 4 for Patient exhibits a brisk response to a light glabellar (between the eyebrows) tap or a loud auditory stimulus, 5 for Patient exhibits a sluggish response to a light glabellar tap or a loud auditory stimulus and 6 for Patient exhibits no response to stimulus. • Patient tolerance to endotracheal tube. • Total duration for successful tracheal intubation. • Hemodynamic parameters
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •18-75 year olds
- •ASA I-III
- •Maxillofacial trauma patients
- •Patients with oral carcinoma 5.
Exclusion Criteria
- •Nasal trauma
- •Pregnant and lactating women
- •Heart Rate less than 50 bpm
- •AV block on ECG
- •History of angina
- •Liver cirrhosis
- •History of long time opioid use or use within last 14days
- •Allergy to drugs.
Outcomes
Primary Outcomes
first attempt success rate and quality of intubation
Time Frame: Time interval between sedation and confirmation of ventilation with end tidal carbon dioxide being displayed on the monitor, in the first attempt, approximately 10minutes after the loading dose is completed
Secondary Outcomes
- time required to achieve RSS of 2(interval between start of sedation to when patient is cooperative, oriented & tranquil, approximately 5minutes after the loading dose is completed)
- Total duration for successful tracheal intubation(sum of all attempts taken to successfully intubate the patient endotracheally, approximately 15minutes after the loading dose is completed)
Investigators
Dr N Hemapriya
M S Ramaiah Medical College