What side effects are associated with this type of intervention?

Common side effects of anesthesia treatments, particularly those involving agents like propofol and rocuronium used in Modified Time Principle Induction (MTPI) for tracheal intubation, include hypotension, bradycardia, and respiratory depression. Propofol can cause pain at the injection site, and rapid administration may lead to a significant reduction in blood pressure. Rocuronium, a neuromuscular blocking agent, can cause prolonged muscle paralysis and, in rare cases, allergic reactions. General anesthesia side effects also include nausea, vomiting, and postoperative confusion or delirium.

What prior FDA approvals exist?

The FDA has approved several anesthetic agents and techniques for tracheal intubation, including the use of rocuronium and propofol. Rocuronium is a neuromuscular blocking agent that facilitates rapid sequence intubation by providing muscle relaxation. Propofol is a widely used intravenous anesthetic known for its rapid onset and short duration of action, making it suitable for induction and maintenance of anesthesia. The Modified Time Principle Induction (MTPI) technique, which involves the rapid co-administration of these agents, aims to optimize intubation conditions by synchronizing the onset of muscle relaxation and anesthesia. This method is designed to improve the efficiency and safety of tracheal intubation in clinical settings.

What other types of research exist?

One promising alternative to Modified Time Principle Induction (MTPI) for tracheal intubation is the use of rapid co-administration of rocuronium and propofol. This method aims to achieve optimal intubation conditions more quickly and with potentially fewer adverse events compared to classical induction techniques. Another alternative is the use of laryngeal mask airway (LMA) insertion after induction with propofol, which has been shown to be superior to thiopentone for this purpose. These methods offer efficient and effective options for anesthesia induction and tracheal intubation.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of induction to 5 minutes of successful ventilation

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

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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.