CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
sugammadex +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03112993
NCT03112993Phase 4Completed

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

University of Missouri-Columbia·interventional·Posted Apr 13, 2017·Updated Apr 1, 2022

In Brief

A Phase 4 clinical trial evaluating sugammadex and Neostigmine for Spine Surgery. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpine Surgery
CountriesUnited States

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedApr 13, 2017
Enrollment StartMay 30, 2017
Primary CompletionAug 13, 2018
Study CompletionAug 14, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.2 years ago

Interventions

sugammadexdrug

once at the end of the surgery

Neostigminedrug

once at the end of the surgery