AnesthesiaPhase 4NCT05509192
Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction
A Phase 4 study testing MTPI and Classic Induction in people with Anesthesia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- MTPI and Classic Induction
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2022to 24 Jan 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI >30 kg/M2 or Mallampati class III or IV
- Requiring general anesthesia and endotracheal intubation
Who cannot join
- 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
Show all 11Show fewer
- 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
- Induction requiring succinylcholine
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction: A Prospective Randomized and Blind Trial
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.
- Conditions
- Anesthesia
- Being tested
- MTPI, Classic Induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| MTPI group | Experimental | Not described Receives: Drug: MTPI |
| Classic Induction group | Active comparator | Not described Receives: Drug: Classic Induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Total Time Between Laryngoscope Insertion Into Mouth and the Onset of Ventilation After Tracheal Intubation
Measured: Between laryngoscope insertion to onset of ventilation (less than 7 minutes)
Secondary outcomes (24)
Number of Participants for Whom Tracheal Intubations Were Successful on the First Attempt
Measured: after 5 minutes of successful ventilation
Number of Times Tracheal Intubations Are Attempted
Measured: after 5 minutes of successful ventilation
Number of Participants for Whom Tracheal Intubations Failed
Measured: 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)
Measured: from start of induction to 5 minutes of successful ventilation
Minimum Systolic Blood Pressure
Measured: from the start of induction drug administration to about 5 minutes after successful ventilation
Maximum Systolic Blood Pressure
Measured: from the start of induction drug administration to about 5 minutes after successful ventilation
Minimum Diastolic Blood Pressure
Measured: from the start of induction drug administration to about 5 minutes after successful ventilation
Maximum Diastolic Blood Pressure
Measured: from the start of induction drug administration to about 5 minutes after successful ventilation
Minimum Heart Rate
Measured: from the start of induction drug administration to about 5 minutes after successful ventilation
Maximum Heart Rate
Measured: from the start of induction drug administration to about 5 minutes after successful ventilation
Minimum Oxygen Saturation (SpO2)
Measured: from the start of induction drug administration to about 5 minutes after successful ventilation
Maximum Oxygen Saturation (SpO2)
Measured: from the start of induction drug administration to about 5 minutes after successful ventilation
Expired Tidal Volume
Measured: from the start of induction drug administration to about 5 minutes after successful ventilation
End-tidal Carbon Dioxide (CO2) Level
Measured: 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
Measured: within 24 hours after surgery
Physical Response During Intubation, as Assessed by the Number of Participants Who Moved
Measured: during surgery
Physical Response During Intubation, as Assessed by the Number of Participants Who Coughed
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: within one hour after surgery
Number of Participants Who Had Recollection of Pain on Induction
Measured: within one hour after surgery
Provider Determination of Intubating Conditions, Based on Whether Intubation Was Classified as "Not Difficult" or "Difficult"
Measured: at time of surgery
Number of Participants Who Had Vomiting as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Measured: within one hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start17 Aug 2022
- Primary completion24 Jan 2025
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Nakazawa, The University of Texas Health Science Center, Houston
- Investigators
- Lauren M Nakazawa, MD, MBA, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509192
- Sponsor's protocol ID
- HSC-MS-22-0495
- Status last verified
- Jan 2026
- First submitted
- 16 Aug 2022
- Last updated
- 11 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intubation Conditions Achieved With Rapid Co-administration of Rocuronium and Propofol Versus Classical Induction: A Prospective Randomized and Blind Trial
- ClinicalTrials.gov ID
- NCT05509192
- Acronym / sponsor ID
- HSC-MS-22-0495
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Posted 11 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTPI group | Experimental | Drug: MTPI |
| Classic Induction group | Active comparator | Drug: Classic Induction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI >30 kg/M2 or Mallampati class III or IV
- Requiring general anesthesia and endotracheal intubation
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTPIPatients 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. | Drug | MTPI group |
| Classic InductionPatients 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. | Drug | Classic Induction group |
Primary outcome
The Total Time Between Laryngoscope Insertion Into Mouth and the Onset of Ventilation After Tracheal Intubation
Time frame: Between laryngoscope insertion to onset of ventilation (less than 7 minutes)
24 secondary outcomes
Number of Participants for Whom Tracheal Intubations Were Successful on the First Attempt
Time frame: after 5 minutes of successful ventilation
Number of Times Tracheal Intubations Are Attempted
Time frame: after 5 minutes of successful ventilation
Number of Participants for Whom Tracheal Intubations Failed
Time frame: 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)
Time frame: from start of induction to 5 minutes of successful ventilation
Minimum Systolic Blood Pressure
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Maximum Systolic Blood Pressure
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Minimum Diastolic Blood Pressure
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Maximum Diastolic Blood Pressure
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Minimum Heart Rate
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Maximum Heart Rate
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Minimum Oxygen Saturation (SpO2)
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Maximum Oxygen Saturation (SpO2)
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Expired Tidal Volume
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
End-tidal Carbon Dioxide (CO2) Level
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Number of Participants That Had Injury Associated With Intubation
Time frame: within 24 hours after surgery
Physical Response During Intubation, as Assessed by the Number of Participants Who Moved
Time frame: during surgery
Physical Response During Intubation, as Assessed by the Number of Participants Who Coughed
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: within one hour after surgery
Number of Participants Who Had Recollection of Pain on Induction
Time frame: within one hour after surgery
Provider Determination of Intubating Conditions, Based on Whether Intubation Was Classified as "Not Difficult" or "Difficult"
Time frame: at time of surgery
Number of Participants Who Had Vomiting as Assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Time frame: within one hour after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren M Nakazawa, MD, MBA principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MTPI and Classic Induction in people with Anesthesia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Total Time Between Laryngoscope Insertion Into Mouth and the Onset of Ventilation After Tracheal Intubation (time frame: Between laryngoscope insertion to onset of ventilation (less than 7 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.