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General Anesthetic

MTPI vs Classic Induction for Anesthesia

Phase 4
Recruiting
Led By Lauren M Nakazawa, MD, MBA
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within one hour after surgery
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares two methods to help patients sleep before inserting a breathing tube, checking which method works better and is safer.

Who is the study for?
This trial is for individuals with a BMI over 30 or a Mallampati score of III or IV who need general anesthesia and tracheal intubation. It's not suitable for those with severe respiratory conditions, high-risk physical status, emergency surgery needs, specific induction requirements, pregnancy, untreated heart disease, contraindications to mask ventilation, or allergies to the drugs used.
What is being tested?
The study aims to compare two methods of inducing anesthesia: Modified Time Principle Induction (MTPI) versus Classic Induction (CI). It will evaluate how well each method prepares patients for tracheal intubation and monitor any adverse effects that may occur during the process.
What are the potential side effects?
Potential side effects from the anesthetic drugs propofol and rocuronium include allergic reactions, breathing difficulties, low blood pressure, nausea or vomiting. The severity of side effects can vary based on individual patient factors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of induction to 5 minutes of successful ventilation
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of induction to 5 minutes of successful ventilation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Airway view at the time of laryngoscopy as categorized by the modified Cormack-Lehane classification (before external manipulation)
Number of participants that had injury associated with intubation
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
+1 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MTPI groupExperimental Treatment1 Intervention
Group II: Classic Induction groupActive Control1 Intervention

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common anesthesia treatments, such as propofol and rocuronium, work through distinct mechanisms to achieve sedation and muscle relaxation. Propofol, a hypnotic agent, acts by enhancing the inhibitory neurotransmitter GABA, leading to sedation and loss of consciousness. Rocuronium, a neuromuscular blocking agent, works by competitively inhibiting acetylcholine at the neuromuscular junction, causing muscle paralysis. These mechanisms are crucial for anesthesia patients as they ensure rapid and effective induction of anesthesia, facilitating procedures like tracheal intubation. The timing and administration rate of these agents, as studied in Modified Time Principle Induction (MTPI), are vital to optimize their efficacy and minimize adverse effects, ensuring patient safety and procedural success.
The effect of speed of injection on the potency of anaesthetic induction agents.Influence of rate of administration on the mechanism behind propofol induced loss of consciousness.Influence of rate of administration on the mechanism behind propofol induced loss of consciousness.

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,714 Total Patients Enrolled
Lauren M Nakazawa, MD, MBAPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

Classic Induction (General Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05509192 — Phase 4
~43 spots leftby Dec 2025
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