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

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06029049
• Other study ID #: HSC-MS-23-0468
• Status: Recruiting
• Phase: Phase 4
• Start date: September 13, 2023
• Est. completion date: September 12, 2024

Study information

• Verified date: November 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Lauren M Nakazawa, MD,MBA
• Phone: 713-500-6775
• Email: Lauren.M.Nakazawa[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: September 12, 2024
• Est. primary completion date: September 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• 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
• RSI succinylcholine
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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))
Primary	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))
Primary	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))
Primary	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))
Primary	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	Number of participants for whom tracheal intubations were successful on the first attempt		5 minutes after intubation and successful ventilation
Secondary	Number of times tracheal intubations are attempted		5 minutes after intubation and successful ventilation
Secondary	Number of participants for whom tracheal intubations failed		After 3 failed intubation attempts (less than 7 minutes from start of intubation)
Secondary	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
Secondary	Satisfaction of providers with intubating conditions	Providers will answer yes or no for satisfaction	from 5 minutes of successful ventilation
Secondary	Heart Rate		from the start of induction drug administration to about 5 minutes after successful ventilation
Secondary	Diastolic Blood Pressure		from the start of induction drug administration to about 5 minutes after successful ventilation
Secondary	Systolic Blood Pressure		from the start of induction drug administration to about 5 minutes after successful ventilation
Secondary	End-tidal carbon dioxide (CO2)		from the start of induction drug administration to about 5 minutes after successful ventilation
Secondary	Oxygen saturation (SpO2)		from the start of induction drug administration to about 5 minutes after successful ventilation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of participants who had recollection of pain on induction		within 24 hours after surgery