Comparison of Intubation Conditions During Rapid Sequence Induction Obtained With Modified Time Principal Induction With a Standard Intubation Dose of Rocuronium Versus Succinylcholine

NCT ID: NCT06029049

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-13

Study Completion Date

2025-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Modified Time Principle Induction (MTPI) with rocuronium

Group Type EXPERIMENTAL

Modified Time Principle Induction (MTPI) with rocuronium

Intervention Type DRUG

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 with succinylcholine

Group Type ACTIVE_COMPARATOR

RSI succinylcholine

Intervention Type DRUG

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

Interventions

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Modified Time Principle Induction (MTPI) with rocuronium

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

Intervention Type DRUG

RSI succinylcholine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Lauren Nakazawa

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lauren M Nakazawa, MD,MBA

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lauren M Nakazawa, MD,MBA

Role: CONTACT

Phone: 713-500-6775

Email: [email protected]

Ellie Tuchaai

Role: CONTACT

Phone: 713.614.9355

Email: [email protected]

Facility Contacts

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Lauren M Nakazawa, MD,MBA

Role: primary

Ellie Tuchaai

Role: backup

Other Identifiers

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HSC-MS-23-0468

Identifier Type: -

Identifier Source: org_study_id