Speed of Recovery of Reversal of Neuromuscular Blockade in Geriatric Patients Undergoing Spine Surgery

NCT03112993 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: IRB # 2008066MISP # 56051.
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spine Surgery

Keywords

spine surgery; neuromuscular blockade; sugammadex; elderly; reversal; neostigmine; recovery

Outcome Measures

Primary Outcomes (2)

• Difference in Time of Neuromuscular Recovery From a Neuromuscular Moderate Blockade

  Speed of neuromuscular recovery in minutes measured by recovery of the T4:T1 ratio ≥ 0.9 (measured with a TOF-Watch SX)

  Day 1

• Difference in Time From Neuromuscular Reversal to Exit From OR

  Difference in time from neuromuscular reversal to exit from OR was measured in minutes.

  Day 1

Secondary Outcomes (2)

• Difference in Time From Neuromuscular Reversal to Tracheal Extubation

  Day 1

• Difference in Length of Stay in PACU

  Day 1

Other Outcomes (1)

• Difference in Time to First Ambulation After Surgery

  From Day 1 up to 1 week, depending on individual recovery time

Study Arms (2)

Sugammadex group

EXPERIMENTAL

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.

Drug: sugammadex

Neostigmine group

ACTIVE COMPARATOR

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

Interventions

sugammadex DRUG

once at the end of the surgery

Also known as: Bridion

Sugammadex group

Neostigmine DRUG

once at the end of the surgery

Neostigmine group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Posterior spinal surgery
• Age ≥ 65 years
• American Society of Anesthesiologists (ASA) grade I-III

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University on Missouri Hospital

Columbia, Missouri, 65212, United States

Location

Related Publications (1)

• Mraovic B, Timko NJ, Choma TJ. Comparison of recovery after sugammadex or neostigmine reversal of rocuronium in geriatric patients undergoing spine surgery: a randomized controlled trial. Croat Med J. 2021 Dec 31;62(6):606-613. doi: 10.3325/cmj.2021.62.606.

  PMID: 34981693 RESULT

MeSH Terms

Interventions

Sugammadex; Neostigmine

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Results Point of Contact

• Title: Dr. Boris Mraovic, MD, Professor of Clinical Anesthesiology
• Organization: University of Missouri

mraovicb@health.missouri.edu

573-882-2568

Study Officials

• Boris Mraovic, MD

  Univesity of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Anesthesiology

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 13, 2017
• Study Start: May 30, 2017
• Primary Completion: August 13, 2018
• Study Completion: August 14, 2018
• Last Updated: April 1, 2022
• Results First Posted: February 10, 2020

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)