NCT03112993

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

Completed Phase 4 Results posted Last updated 1 April 2022

What this trial tests

Phase 4 trial testing sugammadex in Spine Surgery in 40 participants. Completed in 14 August 2018.

Timeline

30 May 2017

Primary endpoint
13 August 2018

14 August 2018

Quick facts

Lead sponsor	University of Missouri-Columbia
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	40
Start date	30 May 2017
Primary completion	13 August 2018
Estimated completion	14 August 2018
Sites	1 location across United States

Drugs / interventions tested

• sugammadex — full drug profile →
• Neostigmine (NEOSTIGMINE) — full drug profile →

Conditions studied

• Spine Surgery — all drugs for Spine Surgery →

Sponsor

University of Missouri-Columbia

Who can join

65 and older, any sex, with Spine Surgery. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Difference in Time of Neuromuscular Recovery From a Neuromuscular Moderate Blockade Primary · Day 1

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

Group	Value	95% CI
Sugammadex Group	3.9	± 2.2
Neostigmine Group	26.29	± 17.51

Difference in Time From Neuromuscular Reversal to Exit From OR Primary · Day 1

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

Group	Value	95% CI
Sugammadex Group	3.9	± 2.2
Neostigmine Group	19.8	± 13.8

Difference in Time From Neuromuscular Reversal to Tracheal Extubation Secondary · Day 1

Difference in time from neuromuscular reversal to tracheal extubation was measured in minutes.

Group	Value	95% CI
Sugammadex Group	5.3	± 2.5
Neostigmine Group	23.6	± 18.7

Difference in Length of Stay in PACU Secondary · Day 1

Length of PACU stay measured in minutes.

Group	Value	95% CI
Sugammadex Group	81.4	± 16.5
Neostigmine Group	85.3	± 29.5

Difference in Time to First Ambulation After Surgery Secondary · From Day 1 up to 1 week, depending on individual recovery time

Time from end of anesthesia to the first subject ambulation in hours.

Group	Value	95% CI
Sugammadex Group	17.4	± 14.6
Neostigmine Group	17.8	± 11.1

Adverse events — posted to ClinicalTrials.gov

Time frame: Each subjects was assessed for all-cause mortality, serious adverse events, and other adverse events across their entire duration of study participation, which was the time a subject provided written informed consent until their inpatient hospital discharge following surgery. This time frame was on average 4 days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sugammadex Group

Serious: 2/19 (11%)

Deaths: 0/19

Neostigmine Group

Serious: 4/21 (19%)

Deaths: 0/21

Serious adverse events (3 terms)

Reaction	System	Sugammadex Group	Neostigmine Group
Blood transfusion	Surgical and medical procedures	—	—
Prolonged hospitalization	Surgical and medical procedures	—	—
ICU admission	Surgical and medical procedures	—	—

Most-reported serious reactions: Blood transfusion, Prolonged hospitalization, ICU admission.

Data from ClinicalTrials.gov NCT03112993 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of recovery after sugammadex or neostigmine reversal of rocuronium in geriatric patients undergoing spine surgery: a randomized controlled trial.
   Mraovic B, Timko NJ, Choma TJ. · · 2021 · cited 5× · PMID 34981693