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GA/Spinal vs. GA/Spinal/NMB for Operative Repair of Hip Fracture

NCT03226080 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-08-20

No results posted yet for this study

Summary

Surgical repair of hip fractures may be performed with various anesthetic techniques, but are most commonly completed under general anesthesia (GA) or neuraxial anesthesia (NA). Numerous prospective and retrospective studies demonstrate improved morbidity and mortality when NA is used; however, many surgeons prefer the use of GA with neuromuscular blockade (NMB) due to the perception of better operative conditions. This study aims to compare the operative conditions obtained from the use of combined GA and spinal with NMB vs. the use of GA with spinal without NMB. 84 patients will all receive a single shot spinal and GA and then will be randomized to receive either NMB or placebo. The fracture reduction time will be measured.

Conditions

  • Hip Fractures
  • Anesthesia, Spinal
  • Anesthesia, General
  • Neuromuscular Blockade

Interventions

DRUG

Rocuronium

The neuromuscular blockade group will receive intravenous rocuronium

DRUG

Sugammadex

The neuromuscular blockade group will receive intravenous sugammadex for reversal of residual rocuronium

DRUG

Normal saline

Normal saline will be administered as a placebo in equal volume for the placebo group

Sponsors & Collaborators

  • Loyola University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-19
Primary Completion
2019-08-31
Completion
2020-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03226080 on ClinicalTrials.gov