Combined General and Spinal Anesthesia vs. Combined General and Spinal Anesthesia With Neuromuscular Blockade for Operative Repair of Hip Fractures
Description:
Eighty-four ASA I-IV patients presenting for operative repair of an unstable
intertrochanteric femur fracture will be enrolled. This will include fractures classified
according to the Orthopaedic Trauma Association / Arbeitsgemeinschaft fur
Osteosynthesisfragen (OTA/AO) classification system as 31A2.2, 31A2.3, 31A3.1, 31A3.2, and
31A3.3.15 After consent and upon arrival to the operating room, 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 10mg
(1.2mL) of hyperbaric 0.75% bupivicaine as per standard practice. The patient will then be
given a standard general anesthetic induction consisting of propofol, succinylcholine,
fentanyl, and lidocaine. The patient will be intubated and anesthesia will be maintained with
desflurane in oxygen and air. At the time of incision, the patient will be randomized to one
of two groups. The surgeon and the anesthesiologist will be blinded to the patient’s
randomization status. Group 1 (NMB) will be given IV rocuronium 0.6mg/kg in a volume of 10cc.
Group 2 (placebo) will be given 10cc normal saline. The anesthesia practitioner will test a
Train of Four (TOF) and confirm a return of twitches prior to administering the study
intervention. The nerve stimulator will then be disconnected until the conclusion of the
case. Hemodynamic changes which suggest light anesthesia will be treated with additional
fentanyl in 50mcg increments and/or increasing the desflurane concentration. Any hypotension
directly attributed to the anesthetic by the anesthetic practitioner will be managed using a
phenylephrine bolus and/or infusion as per standard anesthetic practice. Surgery will be
performed by one of three fellowship trained orthopedic trauma surgeons, and fixation of
these fractures will be with a single type of cephalomedullary implant (Synthes TFN-A, West
Chester, PA). These three surgeons employ an identical bed, patient position, and traction
technique (sterile skeletal traction) for these procedures. A percutaneous reduction will
first be attempted. If unsuccessful, an open reduction will then be pursued. Following
adequate reduction, fixation with the cephalomedullary implant will then be completed. Once
skin closure has been initiated, to reverse any NMB, sugammadex 200mg in 2ml will be given to
those patients randomized to the NMB group, and 2mL normal saline for the placebo group. At
the discretion of the attending anesthesiologist, a nerve stimulator may be reapplied not
less than 5 minutes after NMB reversal (or saline) is given. Once the attending surgeon has
evaluated the final radiographs, all patients will have their anesthetics discontinued and
will be extubated after emergence from anesthesia.
Condition:
Hip Fractures
Treatment:
Rocuronium
Start Date:
July 19, 2017
Sponsor:
Loyola University
For More Information:
https://clinicaltrials.gov/show/NCT03226080