NCT07835295

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for phase_4

Timeline
27mo left

Started Sep 2026

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Jan 2029

Study Start

First participant enrolled

September 1, 2026

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

September 14, 2026

Last Update Submit

September 18, 2026

Conditions

Airway ManagementEndotracheal Intubation

Outcome Measures

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.

    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

    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

    Within 5 minutes after the study drug administration.

  • Cormack-Lehane Grade of Glottic Visualization grade

    During the first laryngoscopy attempt after study drug administration.

  • Intubation Difficulty Scale Score

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

  • Number of Laryngoscopy Attempts

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

  • +14 more secondary outcomes

Study Arms (4)

Low-Dose Remifentanil

EXPERIMENTAL

Participants receive remifentanil 2 mcg/kg intravenous bolus after standardized propofol induction.

Drug: Low-Dose Remifentanil

High-Dose Remifentanil

EXPERIMENTAL

Participants receive remifentanil 4 mcg/kg intravenous bolus after standardized propofol induction.

Drug: High-Dose Remifentanil

Succinylcholine Control

ACTIVE COMPARATOR

Participants receive succinylcholine 1 mg/kg intravenous bolus after standardized propofol induction.

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.

Drug: RocuroniumDrug: Sugammadex

Interventions

Low-Dose RemifentanilDRUG

Remifentanil 2 mcg/kg intravenous bolus

Low-Dose Remifentanil
High-Dose RemifentanilDRUG

Remifentanil 4 mcg/kg intravenous bolus

High-Dose Remifentanil
SuccinylcholineDRUG

Succinylcholine 1 mg/kg intravenous bolus

Succinylcholine Control
RocuroniumDRUG

Rocuronium 0.6 mg/kg intravenous bolus

Rocuronium With Sugammadex
SugammadexDRUG

Sugammadex reversal after intubation

Rocuronium With Sugammadex

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Interventions

RemifentanilSuccinylcholineRocuroniumSugammadex

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCholineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesSuccinatesDicarboxylic AcidsOnium CompoundsAndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compoundsgamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Officials

  • Shaun Gruenbaum, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariel Anne Reyes

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 14, 2026

First Posted

September 22, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

September 22, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)