Speed of Recovery of Reversal of Neuromuscular Blockade in Geriatric Patients Undergoing Spine Surgery
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| ClinicalTrials.gov Identifier: NCT03112993 |
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Recruitment Status :
Completed
First Posted : April 13, 2017
Results First Posted : February 10, 2020
Last Update Posted : April 1, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Spine Surgery | Drug: sugammadex Drug: Neostigmine | Phase 4 |
The elderly (age ≥ 65 years) population is the fastest growing segment of the American population. Spine surgery is one of the most common operative procedures in the United States and, as the population ages, a larger percentage of geriatric patients will require this procedure. In addition, spinal surgery is often more complex in the elderly population, resulting in longer surgical times. A previous study reported that the rate of complex procedures increased 15-fold in Medicare recipients. Spine surgery is performed in the prone position and neuromuscular blockade (NMB) is maintained until the patient is returned to the supine position at the end of surgery to avoid the risk of patient movement, injury, and inadvertent tracheal extubation while prone. Currently, NMB is reversed with neostigmine immediately after turning the patients back to the supine position at the end of the procedure.
Rocuronium bromide, an intermediate-acting neuromuscular blocking agent (NMBA), is used in approximately 60% of surgical cases in the United States and is commonly used for muscle relaxation during spinal surgery. With aging, the clearance and half-life of rocuronium is prolonged resulting in a wide variability in the duration of action and time to reversal. Until recently, the only medication available for the reversal of neuromuscular blockade was neostigmine and postoperative residual neuromuscular block (PRNB) was common, especially in elderly patients. A recent study reported that PRNB occurred in 58% of elderly patients who were maintained at a moderate level (2 twitches in the TOF) of muscle relaxation with rocuronium during elective surgery. As a result, these older adults experienced an increased incidence of airway obstruction, hypoxemic events, muscle weakness, postoperative pulmonary complications, and increased PACU and hospital lengths of stay.
A new neuromuscular reversal agent sugammadex (Bridion®) has the ability to rapidly reverse both moderate and deep rocuronium-induced NMB. Another study reported that the mean time to complete reversal (TOF ratio ≥ 0.9) of a moderate block (2 twitches in the TOF) with sugammadex in geriatric patients was 2.9 minutes, which was only 1 minute longer than in younger patients. Reversal of NMB with neostigmine is much slower and it is reported to take approximately 19 minutes to achieve complete reversal in middle-aged patients. There is little available data on the NMB reversal time in older adults, but it will likely be even longer because the age-related physiologic changes prolong neuromuscular recovery. Thus, sugammadex has the potential to more rapidly reverse NMB in geriatric patients at the end of surgery. As a result, the use of sugammadex should decrease time in the OR and possibly PACU time and result in cost savings.
Neostigmine has cardiac muscarinic effects and, therefore, has to be administered with an anticholinergic agent such as glycopyrrolate to counteract these effects. A previous study found a 16% incidence of cardiac dysrhythmias in elderly patients who received neostigmine/glycopyrrolate NMB reversal. The ability of sugammadex to completely reverse NMB without the addition of an anticholinesterase agent should result in an improved safety profile in elderly patients.
The goal of this prospective, randomized, double-blinded controlled trial is to test the hypothesis that the reversal of neuromuscular blockage with sugammadex as compared to neostigmine in geriatric patients will provide a shorter time to complete recovery of neuromuscular function, improve the workflow in the operating room and decrease operative costs.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Participants will receive (per a randomization schedule) either sugammadex, or neostigmine/glycopyrrolate to reverse neuromuscular blockade at the end of the surgery. The reversal agent will be prepared in a blinded fashion. |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | The surgeon, anesthesiologist, operating room staff, patients, personnel in the postanesthesia care unit (PACU) as well as the investigators collecting the postoperative data will be blinded to the group allocation. |
| Primary Purpose: | Treatment |
| Official Title: | A Prospective, Randomized, Double-Blind Clinical Trial Evaluating the Speed of Recovery and Safety of Reversal of Neuromuscular Blockade With Sugammadex (Bridion™) Versus Neostigmine in Geriatric Patients Undergoing Spine Surgery |
| Actual Study Start Date : | May 30, 2017 |
| Actual Primary Completion Date : | August 13, 2018 |
| Actual Study Completion Date : | August 14, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Sugammadex group
2 mg/kg of sugammadex, IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight.
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Drug: sugammadex
once at the end of the surgery
Other Name: Bridion |
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Active Comparator: Neostigmine group
50 micrograms/kg (not to exceed 5 mg) and glycopyrrolate, 10 micrograms/kg (not to exceed 1 mg), IV once at the end of the surgery. Dosing will be based on actual body weight not ideal body weight. |
Drug: Neostigmine
once at the end of the surgery |
- Difference in Time of Neuromuscular Recovery From a Neuromuscular Moderate Blockade [ Time Frame: Day 1 ]Speed of neuromuscular recovery in minutes measured by recovery of the T4:T1 ratio ≥ 0.9 (measured with a TOF-Watch SX)
- Difference in Time From Neuromuscular Reversal to Exit From OR [ Time Frame: Day 1 ]Difference in time from neuromuscular reversal to exit from OR was measured in minutes.
- Difference in Time From Neuromuscular Reversal to Tracheal Extubation [ Time Frame: Day 1 ]Difference in time from neuromuscular reversal to tracheal extubation was measured in minutes.
- Difference in Length of Stay in PACU [ Time Frame: Day 1 ]Length of PACU stay measured in minutes.
- Difference in Time to First Ambulation After Surgery [ Time Frame: From Day 1 up to 1 week, depending on individual recovery time ]Time from end of anesthesia to the first subject ambulation in hours.
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| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112993
| United States, Missouri | |
| University on Missouri Hospital | |
| Columbia, Missouri, United States, 65212 | |
| Principal Investigator: | Boris Mraovic, MD | Univesity of Missouri-Columbia |
Documents provided by Boris Mraovic, University of Missouri-Columbia:
| Responsible Party: | Boris Mraovic, Professor of Clinical Anesthesiology, University of Missouri-Columbia |
| ClinicalTrials.gov Identifier: | NCT03112993 |
| Other Study ID Numbers: |
IRB # 2008066 MISP # 56051. ( Other Grant/Funding Number: Merck & Co. ) |
| First Posted: | April 13, 2017 Key Record Dates |
| Results First Posted: | February 10, 2020 |
| Last Update Posted: | April 1, 2022 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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spine surgery neuromuscular blockade sugammadex elderly |
reversal neostigmine recovery |
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Neostigmine Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents |
Neurotransmitter Agents Physiological Effects of Drugs Parasympathomimetics Autonomic Agents Peripheral Nervous System Agents |