Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time Principal Induction With a Standard Intubation Dose of Rocuronium Versus Succinylcholine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess and compare conditions for tracheal intubation obtained with modified time principal induction with 0.6 mg/kg rocuronium and 1 mg/kg succinylcholine. Specifically, the investigators will be evaluating ease of laryngoscopy, vocal cord view, vocal cord opening, and movement of limbs and coughing during tracheal intubation in order to assess intubation conditions, to compare efficiency and success rate of tracheal intubation between two induction agents and to determine the rate of patient awareness during induction and post-operative recall of paralysis.

Official Title
-----------------
Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time Principal Induction With a Standard Intubation Dose of Rocuronium Versus Succinylcholine : A Prospective Non-inferiority Randomized and Blind Trial

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: Modified Time Principle Induction (MTPI) with rocuronium
* Drug: RSI succinylcholine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI > 30kg/m2 or Mallampati class III or IV. Requiring general anesthesia and endotracheal intubation Exclusion Criteria: Acute and chronic respiratory disorders, including Chronic obstructive pulmonary disease(COPD) and asthma. The American Society of Anesthesiologists (ASA) physical status classification > III. Patients requiring awake intubation. Pregnant women. Untreated ischemic heart disease. Patients requiring an induction dose of propofol < 1 mg/kg. Allergy to propofol, rocuronium, succinylcholine, or sugammadex. Patients with renal failure and unknown potassium (K+) level, or patients with K+ level > 5.0 Personal history of malignant hyperthermia (MH), or family history of MH Patients with suspected or diagnosed neuromuscular disease, patients with burn injuries

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Time Principle Induction (MTPI) with rocuronium<br> | Drug: Modified Time Principle Induction (MTPI) with rocuronium<br>* Participants will be induced using lidocaine 1 mg/kg IV, an opioid such a fentanyl (1-2 mcg/kg) IV, followed by 0.6 mg/kg IV rocuronium, and IV propofol with dosage at the discretion of the care team, administered within 10 seconds of rocuronium and the intubation will be performed with a C-MAC<br>|
| Active Comparator: RSI with succinylcholine<br> | Drug: RSI succinylcholine<br>* Participants will be induced as per routine care using lidocaine 1 mg/kg IV, an opioid such a fentanyl (1-2 mcg/kg) IV, propofol 1-2 mg/kg IV, and succinylcholine 1mg/kg IV, and the intubation will be performed with a C-MAC<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of laryngoscopy | Ease of laryngoscopy is scored categorically as easy (Jaw relaxed, no resistance to blade during laryngoscopy) , fair (Jaw not fully relaxed, some resistance to blade) or difficult (Poor jaw relaxation, active resistance by patient to laryngoscopy) | During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes)) | 
| Position of vocal cords | Position of vocal cords is scored categorically as abducted, intermediate or closed | During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes)) | 
| Movement of vocal cords | Movement of vocal cords is scored categorically as none , moving or closing | During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes)) | 
| Number of participants who moved their limbs during intubation | none, slight or vigorous | During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes)) | 
| number of participants who coughed during tracheal intubation | none, diaphragm or sustained (>10s) | During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes)) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants for whom tracheal intubations were successful on the first attempt |  | 5 minutes after intubation and successful ventilation | 
| Number of times tracheal intubations are attempted |  | 5 minutes after intubation and successful ventilation | 
| Number of participants for whom tracheal intubations failed |  | After 3 failed intubation attempts (less than 7 minutes from start of intubation) | 
| Airway view at the time of laryngoscopy as categorized by the modified Cormack-Lehane classification (before external manipulation) | Data is reported categorically as follows 1(Full view of glottis),2a(Partial view of glottis), 2b(Only posterior extremity of glottis seen or only arytenoid cartilages), 3(Only epiglottis seen, none of glottis seen) and 4(Neither glottis nor epiglottis seen) | from start of induction to 5 minutes of successful ventilation | 
| Satisfaction of providers with intubating conditions | Providers will answer yes or no for satisfaction | from 5 minutes of successful ventilation | 
| Heart Rate |  | from the start of induction drug administration to about 5 minutes after successful ventilation | 
| Diastolic Blood Pressure |  | from the start of induction drug administration to about 5 minutes after successful ventilation | 
| Systolic Blood Pressure |  | from the start of induction drug administration to about 5 minutes after successful ventilation | 
| End-tidal carbon dioxide (CO2) |  | from the start of induction drug administration to about 5 minutes after successful ventilation | 
| Oxygen saturation (SpO2) |  | from the start of induction drug administration to about 5 minutes after successful ventilation | 
| Number of participants that had injury associated with intubation | Injury is defined as injury to dentition, lips, tongue, and pharyngeal bleeding. | within 24 hours after surgery | 
| Number of participants with muscle paralysis awareness prior to loss of consciousness as assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction |  | within 24 hours after surgery | 
| Number of participants who had presence of sore throat as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction | This is scored from 0(no pain) to 10(worst pain) | within 24 hours after surgery | 
| Number of participants who had nausea as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction |  | within 24 hours after surgery | 
| Number of participants who had vomiting as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction |  | within 24 hours after surgery | 
| Overall patient satisfaction as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction | This is scored from 0(not satisfied) to 10(extremely satisfied) | within 24 hours after surgery | 
| Number of participants who had recollection of pain on induction |  | within 24 hours after surgery |