Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction

Anesthesia Clinical Trial

Official title:

Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction: A Prospective Randomized and Blind Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05509192
• Other study ID #: HSC-MS-22-0495
• Status: Recruiting
• Phase: Phase 4
• Start date: August 16, 2022
• Est. completion date: December 15, 2024

Study information

• Verified date: May 2024
• 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 the conditions for tracheal intubation obtained with Modified Time Principle Induction (MTPI) and that obtained with classic induction (CI). This study will compare the efficiency of tracheal intubation with the two induction techniques, as well as evaluate for potential adverse events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 143
• Est. completion date: December 15, 2024
• Est. primary completion date: November 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• BMI >30 kg/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

• American Society of Anesthesiologists (ASA) physical status classification > III

• Emergency surgery

• Induction requiring cricoid pressure

• Patients requiring awake intubation

• Pregnant women

• Patients who require an induction dose of propofol less than 1 mg/kg

• Untreated ischemic heart disease

• Contraindication to mask ventilation

• Allergy to propofol, rocuronium, or Sugammadex

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• MTPI
Patients from both study groups will receive premedication in the usual fashion, typically 0-2 mg of IV midazolam at the discretion of the care team. Patients in both study groups will receive 1 mg/kg of lidocaine intravenously, followed by an opioid such as fentanyl (1-2 mcg/kg), prior to administration of induction drugs. Patients assigned to MTPI will then be given rocuronium (0.6mg/kg), followed by propofol intravenously as a single bolus within 10 seconds. A typical propofol bolus for induction ranges from 1-2mg/kg, depending on the patient's age, medical history, and co-morbidities. Propofol dosing will be at the discretion of the care team. Patients will count down from one hundred. Once apnea occurs, as indicated by a lack of respiratory effort, the eyes will be taped, and intubation with C-MAC (Karl Storz 8403ZX, Tuttlingen, Germany) is initiated.
• Classic Induction
Patients assigned to CI will be induced as per routine care using lidocaine 1 mg/kg, an opioid such a fentanyl (1-2 mcg/kg), propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg, and the intubation will be performed with a C-MAC. Patients will also count down from one hundred. The medications used for induction of anesthesia in both arms of the study are those used for routine anesthesia care. In both study arms, dosing of medications for induction of anesthesia is standardized (lidocaine 1 mg/kg, fentanyl 1-2 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg). The only difference between the two arms will be the timing of the medication administration, and the order in which medications are administered. The documentation of induction and intubation will be the same as that of the MTPI group. Vital signs and other parameters will continuously be recorded in the intraoperative record. Emergence and extubation are not protocolized.

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	The total time between laryngoscope insertion into mouth and the onset of ventilation after tracheal intubation		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		after 5 minutes of successful ventilation
Secondary	Number of times tracheal intubations are attempted		after 5 minutes of 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	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) level		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 of teeth, lips, tongue, and pharyngeal bleed	within 24 hours after surgery
Secondary	Physical response during intubation, as assessed by the number of participants who moved		during surgery
Secondary	Physical response during intubation, as assessed by the number of participants who coughed		during surgery
Secondary	Number of participants who had Awareness of muscle paralysis before loss of consciousness as assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction		within one hour 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 one hour after surgery
Secondary	Number of participants who had nausea and vomiting as assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction		within one hour 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 one hour after surgery
Secondary	Number of participants who had recollection of pain on induction		within one hour after surgery