REMIfentanil (2 vs. 4 mcg/kg) Facilitated Intubation Without Neuromuscular Blockade Versus Succinylcholine and Rocuronium With Sugammadex for Endotracheal Intubation in Spine Surgery Requiring Motor Evoked Potential Monitoring

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMayo Clinic

About this trial

The purpose of this research is to compare four commonly used anesthesia medication strategies for placing a breathing tube in patients undergoing spine surgery that requires motor evoked potential (MEP) monitoring.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

American Society of Anesthesiologists (ASA) physical status I-III

Scheduled for elective spine surgery (cervical, thoracic, or lumbar) requiring intraoperative MEP monitoring

Able to provide written informed consent

Disqualifiers

Known or suspected difficult airway (Mallampati class IV, history of difficult intubation, limited mouth opening < 3 cm, limited neck extension)

Body mass index (BMI) > 40 kg/m2

Known allergy or hypersensitivity to remifentanil, succinylcholine, rocuronium, sugammadex, or propofol

Personal or family history of malignant hyperthermia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low-Dose Remifentanil

    Drug

    Remifentanil 2 mcg/kg intravenous bolus

  • High-Dose Remifentanil

    Drug

    Remifentanil 4 mcg/kg intravenous bolus

  • Succinylcholine

    Drug

    Succinylcholine 1 mg/kg intravenous bolus

  • Rocuronium

    Drug

    Rocuronium 0.6 mg/kg intravenous bolus

  • Sugammadex

    Drug

    Sugammadex reversal after intubation

Treatment groups

316 Participants
are divided into 4 treatment groups
Group A: Low-Dose RemifentanilExperimental treatment 1 intervention
Group B: High-Dose RemifentanilExperimental treatment 1 intervention
Group C: Succinylcholine ControlActive comparator 1 intervention
Group D: Rocuronium With SugammadexActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants With Clinically Acceptable Intubating Conditions

Clinically acceptable intubating conditions are defined as intubating conditions rated as excellent or good using a standardized intubating conditions assessment. The assessment includes ease of laryngoscopy, vocal cord position and movement, and participant reaction to intubation. Overall intubating conditions are categorized as excellent, good, or poor. Excellent and good conditions will be counted as clinically acceptable, and poor conditions will be counted as not clinically acceptable. The outcome will be reported as the percentage of participants in each arm with clinically acceptable intubating conditions.

Time frame
During the first endotracheal intubation attempt after study drug administration, assessed within approximately 10 minutes after induction of anesthesia

Secondary outcomes

1

Percentage of Participants With Excellent Intubating Conditions

Excellent intubating conditions are defined as all assessed intubating condition domains rated as excellent. Domains include ease of laryngoscopy, vocal cord position and movement, and participant reaction to intubation. The outcome will be reported as the percentage of participants in each arm with excellent intubating conditions.

Time frame
During the first endotracheal intubation attempt after study drug administration, assessed within approximately 10 minutes after induction of anesthesia
2

Percentage of Participants With Successful First-Attempt Endotracheal Intubation

Successful first-attempt endotracheal intubation is defined as successful placement of the endotracheal tube on the first laryngoscopy attempt, confirmed by capnography over four respiratory cycles. The outcome will be reported as the percentage of participants in each arm with successful first-attempt intubation.

Time frame
Within 5 minutes after the study drug administration.
3

Cormack-Lehane Grade of Glottic Visualization grade

Glottic visualization will be assessed using the Cormack-Lehane grading system. Grades range from 1 to 4, with lower grades indicating better visualization of the glottis and higher grades indicating poorer visualization. The outcome will be reported by grade for each arm.

Time frame
During the first laryngoscopy attempt after study drug administration.
4

Intubation Difficulty Scale Score

Intubation difficulty will be assessed using the Intubation Difficulty Scale. Scores range from 0 to infinity, with 0 indicating an easy intubation and scores greater than 5 indicating difficult intubation. The outcome will be reported as the Intubation Difficulty Scale score for each arm.

Time frame
During endotracheal intubation after study drug administration, assessed within approximately 10 minutes after induction of anesthesia

Other outcomes

Sponsors and contacts

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