CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 154 enrolled
Drug / intervention
MTPI +1 moredrug
Likely dose
Propofol 1-2 mg/kg IV; rocuronium 0.6 mg/kg IVAI-extracted
Key inclusion· 2
  • BMI >30 kg/m² or Mallampati class III or IV
  • Requiring general anesthesia and endotracheal intubation
Key exclusion· 8
  • Acute and chronic respiratory disorders, including COPD and asthma
  • ASA physical status >III
  • Emergency surgery
  • Requiring awake intubation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05509192
NCT05509192Phase 4Completed

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

The University of Texas Health Science Center, Houston·interventional·Posted Aug 22, 2022·Updated Feb 11, 2026

In Brief

A Phase 4 clinical trial evaluating MTPI and Classic Induction for Anesthesia. Completed, enrolled 154 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedAug 22, 2022
Enrollment StartAug 17, 2022
Primary CompletionJan 24, 2025
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 3.9 years ago

Interventions

MTPIdrug

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 Inductiondrug

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.