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Airway ManagementPhase 4REMI-MEPNCT07835295

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

A Phase 4 study testing Low-Dose Remifentanil, High-Dose Remifentanil and Succinylcholine in people with Airway Management and Endotracheal Intubation, run by Mayo Clinic at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Airway Management, Endotracheal Intubation
What is being tested?
Low-Dose Remifentanil, High-Dose Remifentanil and Succinylcholine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
316 participants
Where
1 siteUnited States
Study dates
Sep 2026to Jan 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mariel Anne Reyes contact

904-953-4797

reyes.mariel@mayo.edu

United States1 site
  • Mayo Clinic

    Jacksonville, Florida, 32224

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Low-Dose Remifentanil, High-Dose Remifentanil, Succinylcholine, Rocuronium, Sugammadex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • RocuroniumDrug

    Rocuronium 0.6 mg/kg intravenous bolus

  • SugammadexDrug

    Sugammadex reversal after intubation

Study groups in NCT07835295
Study groupRoleWhat they receive
Low-Dose RemifentanilExperimentalParticipants receive remifentanil 2 mcg/kg intravenous bolus after standardized propofol induction.
Receives: Drug: Low-Dose Remifentanil
High-Dose RemifentanilExperimentalParticipants receive remifentanil 4 mcg/kg intravenous bolus after standardized propofol induction.
Receives: Drug: High-Dose Remifentanil
Succinylcholine ControlActive comparatorParticipants receive succinylcholine 1 mg/kg intravenous bolus after standardized propofol induction.
Receives: Drug: Succinylcholine
Rocuronium With SugammadexActive comparatorParticipants receive rocuronium 0.6 mg/kg intravenous bolus after standardized propofol induction, followed by sugammadex reversal after intubation according to protocol.
Receives: Drug: Rocuronium; Drug: Sugammadex

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (19)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

    Measured: Within 5 minutes after the study drug administration

  10. 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.

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

  11. 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.

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

  12. 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.

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

  13. 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.

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

  14. 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.

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

  15. 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.

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

  16. 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.

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

  17. 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.

    Measured: 24 hours after surgery

  18. 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.

    Measured: 48 hours after surgery

  19. 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.

    Measured: From completion of surgery through 48 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionSep 2028 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
316 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07835295
Sponsor's protocol ID
26-007617
Acronym
REMI-MEP
Status last verified
Sep 2026
First submitted
14 Sep 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Low-Dose Remifentanil, High-Dose Remifentanil and Succinylcholine in people with Airway Management and Endotracheal Intubation, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mariel Anne Reyes (904-953-4797, reyes.mariel@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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