Phase 4
N=40
Speed of Recovery of Reversal of Neuromuscular Blockade in Geriatric Patients Undergoing Spine Surgery
Spine Surgery
Bottom Line
View on ClinicalTrials.gov: NCT03112993 ↗Enrolled (actual)
40
Serious AEs
15.0%
Results posted
Feb 2020
Primary outcome: Primary: Difference in Time of Neuromuscular Recovery From a Neuromuscular Moderate Blockade — 3.9; 26.29 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- sugammadex (Drug); Neostigmine (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- University of Missouri-Columbia
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Time of Neuromuscular Recovery From a Neuromuscular Moderate Blockade |
3.9; 26.29 | — |
| PRIMARY Difference in Time From Neuromuscular Reversal to Exit From OR |
3.9; 19.8 | — |
| SECONDARY Difference in Time From Neuromuscular Reversal to Tracheal Extubation |
5.3; 23.6 | — |
| SECONDARY Difference in Length of Stay in PACU |
81.4; 85.3 | — |
Summary
Spine surgery is one of the most common operative procedures in the United States. It is performed in the prone position (a patient laying on belly). Muscle relaxants are given for neuromuscular blockade often referred as paralysis for surgical exposure which is maintained until the patient is returned to the supine position (a patient laying on back) at the end of surgery. At the end of the surgery the paralysis is reversed with a drug (neostigmine). A new drug (sugammadex) has the ability to rapidly reverse the paralysis but it is not well investigated in elderly. This study will investigate speed of recovery and complications of the two reversal drugs in elderly patients (age ≥ 65 years) undergoing posterior spine surgery.
Eligibility Criteria
Inclusion Criteria
- Posterior spinal surgery
- Age ≥ 65 years
- American Society of Anesthesiologists (ASA) grade I-III
Exclusion Criteria
- Inability to obtain written informed consent
- Allergy to rocuronium or anesthetic agents used in the protocol
- Known or suspected neuromuscular disorders
- Significant renal disease with a serum creatinine ≥ 2 mg/dl
- Significant liver disease
- A family history of malignant hyperthermia
Data sourced from ClinicalTrials.gov (NCT03112993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.