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.
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)
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- 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.
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.
- Conditions
- Airway Management, Endotracheal Intubation
- 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 group | Role | What they receive |
|---|---|---|
| Low-Dose Remifentanil | Experimental | Participants receive remifentanil 2 mcg/kg intravenous bolus after standardized propofol induction. Receives: Drug: Low-Dose Remifentanil |
| High-Dose Remifentanil | Experimental | Participants receive remifentanil 4 mcg/kg intravenous bolus after standardized propofol induction. Receives: Drug: High-Dose Remifentanil |
| Succinylcholine Control | Active comparator | Participants receive succinylcholine 1 mg/kg intravenous bolus after standardized propofol induction. Receives: Drug: Succinylcholine |
| Rocuronium With Sugammadex | Active comparator | Participants 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.
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)
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
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted22 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaun Gruenbaum, Mayo Clinic
- Investigators
- Shaun Gruenbaum, MD, Principal investigator, Mayo Clinic
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07835295
- Acronym / sponsor ID
- REMI-MEP / 26-007617
- Conditions
- Airway Management, Endotracheal Intubation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Remifentanil | Experimental | Drug: Low-Dose RemifentanilParticipants receive remifentanil 2 mcg/kg intravenous bolus after standardized propofol induction. |
| High-Dose Remifentanil | Experimental | Drug: High-Dose RemifentanilParticipants receive remifentanil 4 mcg/kg intravenous bolus after standardized propofol induction. |
| Succinylcholine Control | Active comparator | Drug: SuccinylcholineParticipants receive succinylcholine 1 mg/kg intravenous bolus after standardized propofol induction. |
| Rocuronium With Sugammadex | Active comparator | Drug: Rocuronium, Drug: SugammadexParticipants receive rocuronium 0.6 mg/kg intravenous bolus after standardized propofol induction, followed by sugammadex reversal after intubation according to protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Dose RemifentanilRemifentanil 2 mcg/kg intravenous bolus | Drug | Low-Dose Remifentanil |
| High-Dose RemifentanilRemifentanil 4 mcg/kg intravenous bolus | Drug | High-Dose Remifentanil |
| SuccinylcholineSuccinylcholine 1 mg/kg intravenous bolus | Drug | Succinylcholine Control |
| RocuroniumRocuronium 0.6 mg/kg intravenous bolus | Drug | Rocuronium With Sugammadex |
| SugammadexSugammadex reversal after intubation | Drug | Rocuronium With Sugammadex |
Primary outcome
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
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.
19 secondary outcomes
Percentage of Participants 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
Time frame: Within 5 minutes after the study drug administration.
Cormack-Lehane Grade of Glottic Visualization grade
Time frame: During the first laryngoscopy attempt after study drug administration.
Intubation Difficulty Scale Score
Time frame: During endotracheal intubation after study drug administration, assessed within approximately 10 minutes after induction of anesthesia
Number of Laryngoscopy Attempts
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 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
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
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
Time frame: Within 5 minutes after the study drug administration
Percentage of Participants Requiring Adjunct Medication to Facilitate Induction or Intubation
Time frame: From induction of anesthesia through successful endotracheal intubation, assessed within approximately 10 minutes after induction of anesthesia
Change in Mean Arterial Pressure
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
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
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
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 frame: From successful endotracheal intubation until acquisition of baseline motor evoked potentials before patient positioning
Motor Evoked Potential Signal Quality
Time frame: At baseline neuromonitoring assessment after successful endotracheal intubation and before patient positioning
Percentage of Participants With Postoperative Myalgia at 24 Hours
Time frame: 24 hours after surgery
Percentage of Participants With Postoperative Myalgia at 48 Hours
Time frame: 48 hours after surgery
Postoperative Opioid Consumption
Time frame: From completion of surgery through 48 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shaun Gruenbaum, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
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.