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

NCT03226080 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 209397
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Time to complete reduction of the fracture

  Time necessary for complete reduction in the operating room.

  Measured once Post-Op Day #0 in the recovery room

Secondary Outcomes (5)

• Surgical Operative Conditions

  Measured once Post-Op Day #0 in the recovery room

• Estimated Blood Loss

  Measured once Post-Op Day #0 in the recovery room

• Total operating room time

  Measured once Post-Op Day #0 in the recovery room

• Time to extubation

  Measured once Post-Op Day #0 in the recovery room

• Intraoperative fentanyl use

  Measured once Post-Op Day #0 in the recovery room

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients will be monitored and then sedated with midazolam, fentanyl, and ketamine as necessary per standard practice to facilitate lateral positioning. Patients will be positioned with the operative side down for the spinal blockade. Under sterile conditions, spinal anesthesia will be induced with 9mg (1.2mL) of hyperbaric 0.75% bupivacaine as per standard practice. The patient will then be given a standard general anesthetic induction consisting of propofol, succinylcholine, fentanyl, and lidocaine. At the time of incision, this group will be given 10cc normal saline. Once skin closure has been initiated, 2mL normal saline will be administered.

Drug: Normal saline

Neuromuscular Blockade

ACTIVE COMPARATOR

Patients will be monitored and then sedated with midazolam, fentanyl, and ketamine as necessary per standard practice to facilitate lateral positioning. Patients will be positioned with the operative side down for the spinal blockade. Under sterile conditions, spinal anesthesia will be induced with 9mg (1.2mL) of hyperbaric 0.75% bupivacaine as per standard practice. The patient will then be given a standard general anesthetic induction consisting of propofol, succinylcholine, fentanyl, and lidocaine. At the time of incision, this group will be given IV rocuronium 0.6mg/kg in a volume of 10cc. Once skin closure has been initiated, sugammadex 200mg in 2ml will be administered.

Drug: Rocuronium; Drug: Sugammadex

Interventions

Rocuronium DRUG

The neuromuscular blockade group will receive intravenous rocuronium

Neuromuscular Blockade

Sugammadex DRUG

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

Neuromuscular Blockade

Normal saline DRUG

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

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-IV Age 55 or older Scheduled for operative repair of isolated intertrochanteric hip fracture

You may not qualify if:

• Inability to consent/refusal Allergy to any of the study medications Multiple traumatic injuries Contraindication to neuraxial or general anesthesia Pregnancy

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (15)

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  PMID: 25922465 BACKGROUND

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  PMID: 11118174 BACKGROUND

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  PMID: 27496656 BACKGROUND

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  PMID: 27537929 BACKGROUND

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• Mazze RI, Fujinaga M. Postdural puncture headache after continuous spinal anesthesia with 18-gauge and 20-gauge needles. Reg Anesth. 1993 Jan-Feb;18(1):47-51.

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  PMID: 18277234 BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Interventions

Rocuronium; Sugammadex; Saline Solution

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators, surgeons, intraoperative anesthesiology providers, and patients will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 84 patient under GA with spinal anesthesia will be block randomized to either neuromuscular blockade or placebo. Randomization will be tracked by the research pharmacist at Loyola University

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: July 21, 2017
• Study Start: July 19, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2020
• Last Updated: August 20, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)