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

Phase 4Not Yet RecruitingNCT07835295

Mayo Clinic316 enrolled

Overview

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.

Specifically, the study will compare two different doses of remifentanil, succinylcholine, and rocuronium followed by sugammadex to determine which approach provides the best conditions for endotracheal intubation while minimizing interference with nerve monitoring. Researchers will also evaluate how these approaches affect blood pressure and heart rate during anesthesia induction, the quality of motor evoked potential monitoring, the need for additional airway interventions or rescue medications, and the occurrence of side effects such as muscle soreness after surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

316

Conditions

Airway Management Endotracheal Intubation

Interventions

Low-Dose RemifentanilDRUG

Remifentanil 2 mcg/kg intravenous bolus

High-Dose RemifentanilDRUG

Remifentanil 4 mcg/kg intravenous bolus

SuccinylcholineDRUG

Succinylcholine 1 mg/kg intravenous bolus

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Known or suspected pseudocholinesterase deficiency * Conditions predisposing to succinylcholine-induced hyperkalemia (e.g., major burns within the last year, denervation injuries or upper motor neuron lesions within 6 months, severe crush injuries, prolonged immobilization \> 72 hours, known hyperkalemia \> 5.5 mEq/L) * Severe preoperative motor deficit (manual muscle testing ≤ 2/5 in monitored extremities) * Neuromuscular disorders (e.g., myasthenia gravis, muscular dystrophy, Guillain-Barre syndrome, prior stroke with residual motor deficits) * Severe cardiovascular disease (e.g., ejection fraction \< 30%, unstable angina, myocardial infarction within 3 months) * Severe bradycardia (heart rate \< 50 bpm) or high-grade atrioventricular block without a pacemaker * Current use of medications affecting neuromuscular function (aminoglycosides, magnesium infusion, certain antiepileptic meds, etc.) * Emergency surgery * High aspiration risk (e.g., uncontrolled gastroesophageal reflux disease) * Pregnancy or breastfeeding

Locations (1)

Mayo Clinic

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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

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

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.

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.

Central Contacts

Mariel Anne Reyes

CONTACT

904-953-4797 reyes.mariel@mayo.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Rocuronium 0.6 mg/kg intravenous bolus

SugammadexDRUG

Sugammadex reversal after intubation

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

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

Number of Laryngoscopy Attempts

The number of laryngoscopy attempts required to achieve successful endotracheal intubation will be recorded. The outcome will be reported as the number of attempts for each arm.

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

Time From Study Drug Administration to Successful Endotracheal Intubation

Time to successful endotracheal intubation is defined as the elapsed time, in seconds, from administration of the assigned study drug to successful endotracheal tube placement confirmed by capnography. The outcome will be reported in seconds for each arm.

Time frame: From study drug administration until successful endotracheal intubation, assessed within approximately 10 minutes after induction of anesthesia

Percentage of Participants Requiring Rescue Neuromuscular Blockade

Rescue neuromuscular blockade is defined as administration of succinylcholine in participants assigned to a remifentanil arm because of poor intubating conditions or unsuccessful intubation after two attempts. The outcome will be reported as the percentage of participants in the remifentanil arms who required rescue neuromuscular blockade.

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

Percentage of Participants Requiring an Alternative Intubation Technique

Alternative intubation technique is defined as use of an additional airway technique or device, such as a bougie or different laryngoscope blade, to facilitate endotracheal intubation. The outcome will be reported as the percentage of participants in each arm requiring an alternative intubation technique.

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

Percentage of Participants With Movement During Intubation

Participant movement during intubation will be assessed by the blinded observer and recorded as present or absent. Movement may include diaphragmatic movement, coughing, bucking, or other clinically observable movement during intubation. The outcome will be reported as the percentage of participants in each arm with movement during intubation.

Time frame: Within 5 minutes after the study drug administration

Percentage of Participants Requiring Adjunct Medication to Facilitate Induction or Intubation

Adjunct medication is defined as any additional medication administered to facilitate induction or intubation beyond the assigned study drug and standardized induction regimen. Examples may include midazolam, fentanyl, or lidocaine. The outcome will be reported as the percentage of participants in each arm requiring adjunct medication.

Time frame: From induction of anesthesia through successful endotracheal intubation, assessed within approximately 10 minutes after induction of anesthesia

Change in Mean Arterial Pressure

Mean arterial pressure will be measured using standard intraoperative monitoring. Change from baseline will be calculated as the post-induction or intubation value minus the baseline value recorded before induction of anesthesia. The outcome will be reported for each arm.

Time frame: From baseline before induction of anesthesia through successful endotracheal intubation, assessed within approximately 10 minutes after induction of anesthesia

Change in Heart Rate

Heart rate will be measured using standard intraoperative monitoring. Change from baseline will be calculated as the post-induction or intubation value minus the baseline value recorded before induction of anesthesia. The outcome will be reported for each arm.

Time frame: From baseline before induction of anesthesia through successful endotracheal intubation, assessed within approximately 10 minutes after induction of anesthesia

Percentage of Participants With Hypotension, Bradycardia, or Oxygen Desaturation During Induction and Intubation

Hypotension, bradycardia, and oxygen desaturation occurring during induction and intubation will be recorded according to protocol-defined safety monitoring procedures. The outcome will be reported as the percentage of participants in each arm with one or more of these events.

Time frame: From induction of anesthesia through successful endotracheal intubation, assessed within approximately 10 minutes after induction of anesthesia

Percentage of Participants With Intubation-Related Complications

Intubation-related complications include dental trauma, aspiration, airway trauma, or other clinically documented complications related to endotracheal intubation. The outcome will be reported as the percentage of participants in each arm with at least one intubation-related complication.

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

Time From Successful Endotracheal Intubation to Acquisition of Baseline Motor Evoked Potentials

Time to baseline motor evoked potential acquisition is defined as the elapsed time, in minutes, from successful endotracheal intubation to acquisition of baseline motor evoked potential signals according to institutional neuromonitoring procedures. The outcome will be reported in minutes for each arm.

Time frame: From successful endotracheal intubation until acquisition of baseline motor evoked potentials before patient positioning

Motor Evoked Potential Signal Quality

Motor evoked potential signal quality will be assessed using neuromonitoring documentation, including signal amplitude and successful detection of baseline signals. The outcome will be reported for each arm using the protocol-specified signal quality variables.

Time frame: At baseline neuromonitoring assessment after successful endotracheal intubation and before patient positioning

Percentage of Participants With Postoperative Myalgia at 24 Hours

Postoperative myalgia is defined as participant-reported muscle pain after surgery, assessed at approximately 24 hours postoperatively. The outcome will be reported as the percentage of participants in each arm with postoperative myalgia at 24 hours.

Time frame: 24 hours after surgery

Percentage of Participants With Postoperative Myalgia at 48 Hours

Postoperative myalgia is defined as participant-reported muscle pain after surgery, assessed at approximately 48 hours postoperatively. The outcome will be reported as the percentage of participants in each arm with postoperative myalgia at 48 hours.

Time frame: 48 hours after surgery

Postoperative Opioid Consumption

Postoperative opioid consumption will be obtained from the medical record and summarized using the protocol-specified opioid consumption unit or conversion method. The outcome will be reported for each arm over the postoperative assessment period.

Time frame: From completion of surgery through 48 hours after surgery