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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MTPI group | Experimental |
| |
| Classic Induction group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MTPI | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants for Whom Tracheal Intubations Were Successful on the First Attempt | after 5 minutes of successful ventilation | |
| Number of Times Tracheal Intubations Are Attempted | after 5 minutes of successful ventilation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren M Nakazawa, MD, MBA | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | MTPI Group | 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. |
| FG001 | Classic Induction Group | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MTPI Group | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Total Time Between Laryngoscope Insertion Into Mouth and the Onset of Ventilation After Tracheal Intubation | Posted | Median | Inter-Quartile Range | seconds | Between laryngoscope insertion to onset of ventilation (less than 7 minutes) |
|
Up to 24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MTPI Group | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren M Nakazawa, MD, MBA | The University of Texas Health Science Center at Houston | 713-500-6775 | Lauren.M.Nakazawa@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 28, 2025 | Jan 23, 2026 | Prot_SAP_000.pdf |
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|
| Classic Induction | Drug | 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. |
|
| Number of Participants for Whom Tracheal Intubations Failed | after 3 failed intubation attempts (less than 7 minutes from start of intubation) |
| Airway Cord View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (Before External Manipulation) | 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) | from start of induction to 5 minutes of successful ventilation |
| Minimum Systolic Blood Pressure | from the start of induction drug administration to about 5 minutes after successful ventilation |
| Maximum Systolic Blood Pressure | from the start of induction drug administration to about 5 minutes after successful ventilation |
| Minimum Diastolic Blood Pressure | from the start of induction drug administration to about 5 minutes after successful ventilation |
| Maximum Diastolic Blood Pressure | from the start of induction drug administration to about 5 minutes after successful ventilation |
| Minimum Heart Rate | from the start of induction drug administration to about 5 minutes after successful ventilation |
| Maximum Heart Rate | from the start of induction drug administration to about 5 minutes after successful ventilation |
| Minimum Oxygen Saturation (SpO2) | from the start of induction drug administration to about 5 minutes after successful ventilation |
| Maximum Oxygen Saturation (SpO2) | from the start of induction drug administration to about 5 minutes after successful ventilation |
| Expired Tidal Volume | from the start of induction drug administration to about 5 minutes after successful ventilation |
| End-tidal Carbon Dioxide (CO2) Level | 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 of teeth, lips, tongue, and pharyngeal bleed | within 24 hours after surgery |
| Physical Response During Intubation, as Assessed by the Number of Participants Who Moved | during surgery |
| Physical Response During Intubation, as Assessed by the Number of Participants Who Coughed | during surgery |
| 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 | 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. | within one hour after surgery |
| Level of Throat Soreness as Assessed by a Question on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction | Level of throats soreness is scored from 0(no pain) to 10(worst pain), a higher number indicating worse throat soreness. | within one hour after surgery |
| Number of Participants Who Had Nausea as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction | within one hour after surgery |
| Overall Patient Satisfaction as Assessed by a Question on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction | Patient satisfaction is scored from 0(not satisfied) to 10(extremely satisfied), a higher number indicating greater satisfaction. | within one hour after surgery |
| Number of Participants Who Had Recollection of Pain on Induction | within one hour after surgery |
| Provider Determination of Intubating Conditions, Based on Whether Intubation Was Classified as "Not Difficult" or "Difficult" | at time of surgery |
| Number of Participants Who Had Vomiting as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction | within one hour after surgery |
| BG001 | Classic Induction Group | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| American Society of Anesthesiology (ASA) Classification | ASA Physical Status Classification System - The purpose of the system is to assess and communicate a patient's pre-anesthesia medical co-morbidities. ASA I :A normal healthy patient ASA II :A patient with mild systemic disease ASA III: A patient with severe systemic disease ASA IV: A patient with severe systemic disease that is a constant threat to life | Count of Participants | Participants |
|
| Mallampati class | The Mallampati score assesses the relative size of the tongue base in relation to the oropharyngeal opening to predict potential airway difficulty. It is assessed categorically as follows: Class I: Full view of soft palate, uvula, and tonsillar pillars Class II: Soft palate and uvula visible, pillars obscured Class III: Soft palate and uvula base visible Class IV: Visualization restricted to the hard palate | Count of Participants | Participants |
|
| Patients with both BMI ≥ 30 and Mallampati class ≥ 3 | Count of Participants | Participants |
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| Providers' training levels | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | centimeters |
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| Weight | Mean | Standard Deviation | Kilograms |
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| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Classic Induction Group | 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. |
|
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| Secondary | Number of Participants for Whom Tracheal Intubations Were Successful on the First Attempt | Posted | Count of Participants | Participants | after 5 minutes of successful ventilation |
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| Secondary | Number of Times Tracheal Intubations Are Attempted | Posted | Count of Participants | Participants | after 5 minutes of successful ventilation |
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| Secondary | Number of Participants for Whom Tracheal Intubations Failed | Posted | Count of Participants | Participants | after 3 failed intubation attempts (less than 7 minutes from start of intubation) |
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| Secondary | Airway Cord View at the Time of Laryngoscopy as Categorized by the Modified Cormack-Lehane Classification (Before External Manipulation) | 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) | Posted | Count of Participants | Participants | from start of induction to 5 minutes of successful ventilation |
|
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| Secondary | Minimum Systolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | from the start of induction drug administration to about 5 minutes after successful ventilation |
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| Secondary | Maximum Systolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | from the start of induction drug administration to about 5 minutes after successful ventilation |
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| Secondary | Minimum Diastolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | from the start of induction drug administration to about 5 minutes after successful ventilation |
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| Secondary | Maximum Diastolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | from the start of induction drug administration to about 5 minutes after successful ventilation |
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| Secondary | Minimum Heart Rate | Posted | Mean | Standard Deviation | beats per minute (BPM) | from the start of induction drug administration to about 5 minutes after successful ventilation |
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| Secondary | Maximum Heart Rate | Posted | Mean | Standard Deviation | beats per minute (BPM) | from the start of induction drug administration to about 5 minutes after successful ventilation |
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| Secondary | Minimum Oxygen Saturation (SpO2) | Posted | Mean | Standard Deviation | Percentage | from the start of induction drug administration to about 5 minutes after successful ventilation |
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| Secondary | Maximum Oxygen Saturation (SpO2) | Posted | Mean | Standard Deviation | Percentage | from the start of induction drug administration to about 5 minutes after successful ventilation |
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| Secondary | Expired Tidal Volume | Posted | Mean | Standard Deviation | mL | from the start of induction drug administration to about 5 minutes after successful ventilation |
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| Secondary | End-tidal Carbon Dioxide (CO2) Level | Posted | Mean | Standard Deviation | mmHg | from the start of induction drug administration to about 5 minutes after successful ventilation |
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| Secondary | Number of Participants That Had Injury Associated With Intubation | Injury is defined as injury of teeth, lips, tongue, and pharyngeal bleed | Posted | Count of Participants | Participants | within 24 hours after surgery |
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| Secondary | Physical Response During Intubation, as Assessed by the Number of Participants Who Moved | Posted | Count of Participants | Participants | during surgery |
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| Secondary | Physical Response During Intubation, as Assessed by the Number of Participants Who Coughed | Posted | Count of Participants | Participants | during surgery |
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| 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 | 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. | Posted | Count of Participants | Participants | within one hour after surgery |
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| Secondary | Level of Throat Soreness as Assessed by a Question on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction | Level of throats soreness is scored from 0(no pain) to 10(worst pain), a higher number indicating worse throat soreness. | Posted | Mean | Standard Deviation | score on a scale | within one hour after surgery |
|
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| Secondary | Number of Participants Who Had Nausea as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction | Posted | Count of Participants | Participants | within one hour after surgery |
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| Secondary | Overall Patient Satisfaction as Assessed by a Question on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction | Patient satisfaction is scored from 0(not satisfied) to 10(extremely satisfied), a higher number indicating greater satisfaction. | Posted | Mean | Standard Deviation | score on a scale | within one hour after surgery |
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| Secondary | Number of Participants Who Had Recollection of Pain on Induction | Posted | Count of Participants | Participants | within one hour after surgery |
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| Secondary | Provider Determination of Intubating Conditions, Based on Whether Intubation Was Classified as "Not Difficult" or "Difficult" | Posted | Count of Participants | Participants | at time of surgery |
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| Secondary | Number of Participants Who Had Vomiting as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction | Posted | Count of Participants | Participants | within one hour after surgery |
|
|
|
| 0 |
| 77 |
| 0 |
| 77 |
| 0 |
| 77 |
| EG001 | Classic Induction Group | 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. | 0 | 77 | 0 | 77 | 0 | 77 |
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| ASA III: A patient with severe systemic disease |
|
| ASA IV: A patient with severe systemic disease that is a constant threat to life |
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| Class III |
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| Class IV |
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| Unknown |
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| Anesthesia residents |
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| 3 times |
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| 3 |
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| 4 |
|