The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
NCT Number: NCT05509192
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Houston, Texas, 77030, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Between laryngoscope insertion to onset of ventilation (less than 7 minutes)
Time frame: after 5 minutes of successful ventilation
Time frame: after 5 minutes of successful ventilation
Time frame: after 3 failed intubation attempts (less than 7 minutes from start of intubation)
Time frame: from start of induction to 5 minutes of successful ventilation
The Cormack-Lehane classification system is a method used to categorize the airway view at the time of laryngoscopy. Data is reported categorically as follows 1(Full view of glottis),2(Partial view of glottis), 3(Only epiglottis seen, none of glottis seen) and 4(Neither glottis nor epiglottis seen)
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Time frame: within 24 hours after surgery
Injury is defined as injury of teeth, lips, tongue, and pharyngeal bleed
Time frame: during surgery
Time frame: during surgery
Time frame: within one hour after surgery
Awareness of Muscle Paralysis or Weakness before loss of consciousness was assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction through in person interviews to evaluate explicit and implicit recall. Number of Participants with Positive Explicit recall and Positive Implicit recall are reported.
Explicit recall: Participants were asked, "Describe the last thing you remember before falling asleep." If the participant describes memories of paralysis or awareness of the intubation event this is classified as positive explicit recall. If none of these memories are described it is considered negative explicit recall.
Implicit recall: Participants with negative explicit recall, were asked "Did you ever feel weakness or paralysis as you fell asleep?" If they answered yes, this is classified as positive implicit recall.
Time frame: within one hour after surgery
Level of throats soreness is scored from 0(no pain) to 10(worst pain), a higher number indicating worse throat soreness.
Time frame: within one hour after surgery
Time frame: within one hour after surgery
Patient satisfaction is scored from 0(not satisfied) to 10(extremely satisfied), a higher number indicating greater satisfaction.
Time frame: within one hour after surgery
Time frame: at time of surgery
Time frame: within one hour after surgery
The University of Texas Health Science Center, Houston
Other
Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction: A Prospective Randomized and Blind Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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