Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time P… (NCT06029049) | Clinical Trial Compass
RecruitingPhase 4
Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time Principal Induction With a Standard Intubation Dose of Rocuronium Versus Succinylcholine
United States152 participantsStarted 2023-09-13
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* BMI \> 30kg/m2 or Mallampati class III or IV.
* Requiring general anesthesia and endotracheal intubation
Exclusion Criteria:
* 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.
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ease of laryngoscopy
Timeframe: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
2
Position of vocal cords
Timeframe: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
3
Movement of vocal cords
Timeframe: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
4
Number of participants who moved their limbs during intubation
Timeframe: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
5
number of participants who coughed during tracheal intubation
Timeframe: During procedure (Between laryngoscope insertion to onset of ventilation (less than 7 minutes))
Trial details
NCT IDNCT06029049
SponsorThe University of Texas Health Science Center, Houston