Phase 4
Completed N=40
Speed of Recovery of Reversal of Neuromuscular Blockade in Geriatric Patients Undergoing Spine Surgery
Source: ClinicalTrials.gov NCT03112993 ↗Enrolled (actual)
40
Serious AEs
15.0%
Results posted
Feb 2020
Primary outcomePrimary: Difference in Time of Neuromuscular Recovery From a Neuromuscular Moderate Blockade — 3.9; 26.29 Minutes
◆ Published Evidence
Emerging
17citations · ~3 / year
Comparison of recovery after sugammadex or neostigmine reversal of rocuronium in geriatric patients undergoing spine surgery: a randomized controlled trial.
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.
Linked Publications
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Comparison of recovery after sugammadex or neostigmine reversal of rocuronium in geriatric patients undergoing spine surgery: a randomized controlled trial.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.