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

Phase 4RecruitingNCT06029049

The University of Texas Health Science Center, Houston152 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

152

Conditions

Anesthesia

Interventions

Modified Time Principle Induction (MTPI) with rocuronium

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))

Secondary Outcomes

Number of participants for whom tracheal intubations were successful on the first attempt

Time frame: 5 minutes after intubation and successful ventilation

Number of times tracheal intubations are attempted

Time frame: 5 minutes after intubation and successful ventilation

Number of participants for whom tracheal intubations failed

Time frame: 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)

Time frame: from start of induction to 5 minutes of successful ventilation

Satisfaction of providers with intubating conditions

Providers will answer yes or no for satisfaction

Time frame: from 5 minutes of successful ventilation

Heart Rate

Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation

Diastolic Blood Pressure

Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation

Systolic Blood Pressure

Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation

End-tidal carbon dioxide (CO2)

Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation

Oxygen saturation (SpO2)

Time frame: 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.