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Neuromuscular Blocking Agent

Rocuronium vs Succinylcholine 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
BMI > 30kg/m2 or Mallampati class III or IV
Requiring general anesthesia and endotracheal intubation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 3 failed intubation attempts (less than 7 minutes from start of intubation)
Awards & highlights

Study Summary

This trial will compare two drugs for tracheal intubation to assess intubation conditions, efficiency, success rate, patient awareness, and post-op paralysis.

Who is the study for?
This trial is for adults needing general anesthesia and intubation, with a BMI over 30 or a Mallampati score of III/IV. It's not for those allergic to certain anesthetics, pregnant women, people with severe health issues (ASA > III), renal failure with high potassium levels, respiratory disorders like COPD/asthma, untreated heart disease, history of malignant hyperthermia or neuromuscular diseases.Check my eligibility
What is being tested?
The study compares two drugs used during rapid anesthesia induction: rocuronium (0.6 mg/kg) and succinylcholine (1 mg/kg). It looks at how well they work for putting in a breathing tube by checking ease of laryngoscopy, vocal cord view/opening, limb movement and coughing during the procedure.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs used; muscle pain from succinylcholine; changes in heart rate or blood pressure; nausea or vomiting post-operation. Rocuronium may require reversal agents if it lasts too long.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is over 30, or I have a high Mallampati score.
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I will need general anesthesia and a breathing tube for my procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 3 failed intubation attempts (less than 7 minutes from start of intubation)
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 3 failed intubation attempts (less than 7 minutes from start of intubation) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ease of laryngoscopy
Movement of vocal cords
Number of participants who moved their limbs during intubation
+2 more
Secondary outcome measures
Airway view at the time of laryngoscopy as categorized by the modified Cormack-Lehane classification (before external manipulation)
Diastolic Blood Pressure
End-tidal carbon dioxide (CO2)
+14 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Modified Time Principle Induction (MTPI) with rocuroniumExperimental Treatment1 Intervention
Group II: RSI with succinylcholineActive Control1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,808 Total Patients Enrolled
Lauren M Nakazawa, MD,MBAPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the outcomes of Modified Time Principle Induction (MTPI) with rocuronium verified by the FDA?

"After careful consideration, the team at Power assigned Modified Time Principle Induction (MTPI) with rocuronium a score of 3 as it is currently approved and has been through multiple phases of testing."

Answered by AI

Is the opportunity to join this therapeutic experiment still accessible for those seeking medical help?

"According to the clinicaltrials.gov website, this particular trial is not presently accepting participants. The investigation was initially posted on September 5th 2023 and last updated August 31st 2023, however 137 other similar studies are actively recruiting right now."

Answered by AI
~55 spots leftby Sep 2024