Mayo Clinic
Jacksonville, Florida, 32224, United States
NCT Number: NCT07835295
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 4
Jacksonville, Florida, 32224, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Remifentanil 2 mcg/kg intravenous bolus
Remifentanil 4 mcg/kg intravenous bolus
Succinylcholine 1 mg/kg intravenous bolus
Rocuronium 0.6 mg/kg intravenous bolus
Sugammadex reversal after intubation
Time frame: During the first endotracheal intubation attempt after study drug administration, assessed within approximately 10 minutes after induction of anesthesia
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
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: Within 5 minutes after the study drug administration.
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: During the first laryngoscopy attempt after study drug administration.
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 endotracheal intubation after study drug administration, assessed within approximately 10 minutes after induction of anesthesia
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
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: From study drug administration until successful endotracheal intubation, assessed within approximately 10 minutes after induction of anesthesia
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: During attempted endotracheal intubation after study drug administration, assessed within approximately 10 minutes after induction of anesthesia
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
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: Within 5 minutes after the study drug administration
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: From induction of anesthesia through successful endotracheal intubation, assessed within approximately 10 minutes after induction of anesthesia
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 baseline before induction of anesthesia through successful endotracheal intubation, assessed within approximately 10 minutes after induction of anesthesia
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
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 induction of anesthesia through successful endotracheal intubation, assessed within approximately 10 minutes after induction of anesthesia
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: During endotracheal intubation after study drug administration, assessed within approximately 10 minutes after induction of anesthesia
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: From successful endotracheal intubation until acquisition of baseline motor evoked potentials before patient positioning
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: At baseline neuromonitoring assessment after successful endotracheal intubation and before patient positioning
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: 24 hours after surgery
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: 48 hours after surgery
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: From completion of surgery through 48 hours after surgery
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.
Contact information is provided by the study sponsor or research team.
Mayo Clinic
Other
Acronym: REMI-MEP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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