Time necessary for complete reduction in the operating room.
GA/Spinal vs. GA/Spinal/NMB for Operative Repair of Hip Fracture
Brief Summary
Intervention / Treatment
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Rocuronium (DRUG)The neuromuscular blockade group will receive intravenous rocuronium
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Sugammadex (DRUG)The neuromuscular blockade group will receive intravenous sugammadex for reversal of residual rocuronium
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Normal saline (DRUG)Normal saline will be administered as a placebo in equal volume for the placebo group
Condition or Disease
- Hip Fractures
- Anesthesia, Spinal
- Anesthesia, General
- Neuromuscular Blockade
Phase
Study Design
Study type: | INTERVENTIONAL |
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Status: | Withdrawn |
Study results: | No Results Available |
Age: | 55 Years and older (Adult, Older Adult) |
Enrollment: | 0 (ACTUAL) |
Funded by: | Other |
Allocation: | Randomized |
Primary Purpose: | Treatment |
MaskingThe investigators, surgeons, intraoperative anesthesiology providers, and patients will be blinded. TRIPLE:
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Clinical Trial Dates
Start date: | Jul 19, 2017 | ACTUAL |
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Primary Completion: | Aug 01, 2019 | ESTIMATED |
Completion Date: | Aug 01, 2020 | ESTIMATED |
Study First Posted: | Jul 21, 2017 | ACTUAL |
Results First Posted: | Aug 31, 2020 | |
Last Updated: | Aug 17, 2019 |
Sponsors / Collaborators
Location
Participant Groups
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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.
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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.
Eligibility Criteria
Sex: | All |
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Minimum Age: | 55 |
Age Groups: | Adult / Older Adult |
Healthy Volunteers: | Yes |
* ASA I-IV Age 55 or older Scheduled for operative repair of isolated intertrochanteric hip fracture
Exclusion Criteria:
* Inability to consent/refusal Allergy to any of the study medications Multiple traumatic injuries Contraindication to neuraxial or general anesthesia Pregnancy
Primary Outcomes
Secondary Outcomes
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The surgeon's opinion of the operative conditions, as measured using a 4 point likert scale.
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Final estimated blood loss in mL for the procedure
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Total number of minutes spent in the operating room
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Total time from intubation to extubation
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Total amount (in mcg) of intravenous fentanyl used during the procedure
More Details
NCT Number: | NCT03226080 |
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Other IDs: | 209397 |
Study URL: | https://clinicaltrials.gov/study/NCT03226080 |