AnesthesiaPhase 4NCT06029049
Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time Principal Induction With a Standard Intubation Dose of Rocuronium Versus Succinylcholine
A Phase 4 study testing Modified Time Principle Induction (MTPI) with rocuronium and RSI succinylcholine 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 conditions for tracheal intubation obtained with modified time principal induction with 0.6 mg/kg rocuronium and 1 mg/kg succinylcholine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Modified Time Principle Induction (MTPI) with rocuronium and RSI succinylcholine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2023to 1 Jul 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 > 30kg/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.
- The American Society of Anesthesiologists (ASA) physical status classification > III.
- Patients requiring awake intubation.
- Pregnant women.
- Untreated ischemic heart disease.
- Patients requiring an induction dose of propofol < 1 mg/kg.
Show all 10Show fewer
- Allergy to propofol, rocuronium, succinylcholine, or sugammadex.
- Patients with renal failure and unknown potassium (K+) level, or patients with K+ level > 5.0
- Personal history of malignant hyperthermia (MH), or family history of MH
- Patients with suspected or diagnosed neuromuscular disease, patients with burn injuries
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Lauren M Nakazawa, MD,MBA, 713-500-6775, Lauren.M.Nakazawa@uth.tmc.edu
Ellie Tuchaai, 713.614.9355, Ellie.J.Tuchaai@uth.tmc.edu
About this study
Official title: Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time Principal Induction With a Standard Intubation Dose of Rocuronium Versus Succinylcholine : A Prospective Non-inferiority Randomized and Blind Trial
The purpose of this study is to assess and compare conditions for tracheal intubation obtained with modified time principal induction with 0.6 mg/kg rocuronium and 1 mg/kg succinylcholine. Specifically, the investigators will be evaluating ease of laryngoscopy, vocal cord view, vocal cord opening, and movement of limbs and coughing during tracheal intubation in order to assess intubation conditions, to compare efficiency and success rate of tracheal intubation between two induction agents and to determine the rate of patient awareness during induction and post-operative recall of paralysis.
- Conditions
- Anesthesia
- Being tested
- Modified Time Principle Induction (MTPI) with rocuronium, RSI succinylcholine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Time Principle Induction (MTPI) with rocuroniumDrug
Participants will be induced using lidocaine 1 mg/kg IV, an opioid such a fentanyl (1-2 mcg/kg) IV, followed by 0.6 mg/kg IV rocuronium, and IV propofol with dosage at the discretion of the care team, administered within 10 seconds of rocuronium and the intubation will be performed with a C-MAC
RSI succinylcholineDrug
Participants will be induced as per routine care using lidocaine 1 mg/kg IV, an opioid such a fentanyl (1-2 mcg/kg) IV, propofol 1-2 mg/kg IV, and succinylcholine 1mg/kg IV, and the intubation will be performed with a C-MAC
| Study group | Role | What they receive |
|---|---|---|
| Modified Time Principle Induction (MTPI) with rocuronium | Experimental | Not described Receives: Drug: Modified Time Principle Induction (MTPI) with rocuronium |
| RSI with succinylcholine | Active comparator | Not described Receives: Drug: RSI succinylcholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of laryngoscopy
Ease of laryngoscopy is scored categorically as easy (Jaw relaxed, no resistance to blade during laryngoscopy) , fair (Jaw not fully relaxed, some resistance to blade) or difficult (Poor jaw relaxation, active resistance by patient to laryngoscopy)
Measured: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
Position of vocal cords
Position of vocal cords is scored categorically as abducted, intermediate or closed
Measured: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
Movement of vocal cords
Movement of vocal cords is scored categorically as none , moving or closing
Measured: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
Number of participants who moved their limbs during intubation
none, slight or vigorous
Measured: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
number of participants who coughed during tracheal intubation
none, diaphragm or sustained (>10s)
Measured: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
Secondary outcomes (17)
Number of participants for whom tracheal intubations were successful on the first attempt
Measured: 5 minutes after intubation and successful ventilation
Number of times tracheal intubations are attempted
Measured: 5 minutes after intubation and 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 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)
Measured: from start of induction to 5 minutes of successful ventilation
Satisfaction of providers with intubating conditions
Providers will answer yes or no for satisfaction
Measured: from 5 minutes of successful ventilation
Heart Rate
Measured: from the start of induction drug administration to about 5 minutes after successful ventilation
Diastolic Blood Pressure
Measured: from the start of induction drug administration to about 5 minutes after successful ventilation
Systolic Blood Pressure
Measured: from the start of induction drug administration to about 5 minutes after successful ventilation
End-tidal carbon dioxide (CO2)
Measured: from the start of induction drug administration to about 5 minutes after successful ventilation
Oxygen saturation (SpO2)
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 to dentition, lips, tongue, and pharyngeal bleeding.
Measured: within 24 hours after surgery
Number of participants with muscle paralysis awareness prior to loss of consciousness as assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Measured: within 24 hours after surgery
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)
Measured: within 24 hours after surgery
Number of participants who had nausea as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Measured: within 24 hours after surgery
Number of participants who had vomiting as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Measured: within 24 hours after surgery
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)
Measured: within 24 hours after surgery
Number of participants who had recollection of pain on induction
Measured: within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start13 Sep 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 152 participants (estimated)
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
- NCT06029049
- Sponsor's protocol ID
- HSC-MS-23-0468
- Status last verified
- Dec 2024
- First submitted
- 22 Aug 2023
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time Principal Induction With a Standard Intubation Dose of Rocuronium Versus Succinylcholine : A Prospective Non-inferiority Randomized and Blind Trial
- ClinicalTrials.gov ID
- NCT06029049
- Acronym / sponsor ID
- HSC-MS-23-0468
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
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 conditions for tracheal intubation obtained with modified time principal induction with 0.6 mg/kg rocuronium and 1 mg/kg succinylcholine. Specifically, the investigators will be evaluating ease of laryngoscopy, vocal cord view, vocal cord opening, and movement of limbs and coughing during tracheal intubation in order to assess intubation conditions, to compare efficiency and success rate of tracheal intubation between two induction agents and to determine the rate of patient awareness during induction and post-operative recall of paralysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Time Principle Induction (MTPI) with rocuronium | Experimental | Drug: Modified Time Principle Induction (MTPI) with rocuronium |
| RSI with succinylcholine | Active comparator | Drug: RSI succinylcholine |
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 > 30kg/m2 or Mallampati class III or IV.
- Requiring general anesthesia and endotracheal intubation
Key exclusion criteria (10 listed)
- Acute and chronic respiratory disorders, including Chronic obstructive pulmonary disease(COPD) and asthma.
- The American Society of Anesthesiologists (ASA) physical status classification > III.
- Patients requiring awake intubation.
- Pregnant women.
- Untreated ischemic heart disease.
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 |
|---|---|---|
| Modified Time Principle Induction (MTPI) with rocuroniumParticipants will be induced using lidocaine 1 mg/kg IV, an opioid such a fentanyl (1-2 mcg/kg) IV, followed by 0.6 mg/kg IV rocuronium, and IV propofol with dosage at the discretion of the care team, administered within 10 seconds of rocuronium and the intubation will be performed with a C-MAC | Drug | Modified Time Principle Induction (MTPI) with rocuronium |
| RSI succinylcholineParticipants will be induced as per routine care using lidocaine 1 mg/kg IV, an opioid such a fentanyl (1-2 mcg/kg) IV, propofol 1-2 mg/kg IV, and succinylcholine 1mg/kg IV, and the intubation will be performed with a C-MAC | Drug | RSI with succinylcholine |
Primary outcome
Ease of laryngoscopy
Time frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
Ease of laryngoscopy is scored categorically as easy (Jaw relaxed, no resistance to blade during laryngoscopy) , fair (Jaw not fully relaxed, some resistance to blade) or difficult (Poor jaw relaxation, active resistance by patient to laryngoscopy)
Position of vocal cords
Time frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
Position of vocal cords is scored categorically as abducted, intermediate or closed
Movement of vocal cords
Time frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
Movement of vocal cords is scored categorically as none , moving or closing
Number of participants who moved their limbs during intubation
Time frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
none, slight or vigorous
number of participants who coughed during tracheal intubation
Time frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
none, diaphragm or sustained (>10s)
17 secondary outcomes
Number of participants for whom tracheal intubations were successful on the first attempt
Time frame: 5 minutes after intubation and successful ventilation
Number of times tracheal intubations are attempted
Time frame: 5 minutes after intubation and 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 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
Satisfaction of providers with intubating conditions
Time frame: from 5 minutes of successful ventilation
Heart Rate
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Diastolic Blood Pressure
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Systolic Blood Pressure
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
End-tidal carbon dioxide (CO2)
Time frame: from the start of induction drug administration to about 5 minutes after successful ventilation
Oxygen saturation (SpO2)
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
Number of participants with muscle paralysis awareness prior to loss of consciousness as assessed by the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Time frame: within 24 hours after surgery
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
Time frame: within 24 hours after surgery
Number of participants who had nausea as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Time frame: within 24 hours after surgery
Number of participants who had vomiting as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Time frame: within 24 hours after surgery
Overall patient satisfaction as assessed by the score on the Post Anesthesia Care Unit Survey of Modified Time Principle Induction
Time frame: within 24 hours after surgery
Number of participants who had recollection of pain on induction
Time frame: within 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
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 Modified Time Principle Induction (MTPI) with rocuronium and RSI succinylcholine 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 10 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: looking for participants now, as of the sponsor's last update on 10 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren M Nakazawa, MD,MBA (713-500-6775, Lauren.M.Nakazawa@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of laryngoscopy (time frame: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))). The study lists 5 primary outcomes in all. 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 10 Dec 2024.