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- Klinische proef NCT03226080
GA/Spinal vs. GA/Spinal/NMB for Operative Repair of Hip Fracture
17 augustus 2019 bijgewerkt door: Scott Byram MD, Loyola University
Combined General and Spinal Anesthesia vs. Combined General and Spinal Anesthesia With Neuromuscular Blockade for Operative Repair of Hip Fractures
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.
Studie Overzicht
Toestand
Ingetrokken
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Illinois
-
Maywood, Illinois, Verenigde Staten, 60153
- Loyola University Medical Center
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
55 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- 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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Placebo-vergelijker: Placebo
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.
|
Normal saline will be administered as a placebo in equal volume for the placebo group
|
Actieve vergelijker: Neuromuscular Blockade
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.
|
The neuromuscular blockade group will receive intravenous rocuronium
The neuromuscular blockade group will receive intravenous sugammadex for reversal of residual rocuronium
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Time to complete reduction of the fracture
Tijdsspanne: Measured once Post-Op Day #0 in the recovery room
|
Time necessary for complete reduction in the operating room.
|
Measured once Post-Op Day #0 in the recovery room
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Surgical Operative Conditions
Tijdsspanne: Measured once Post-Op Day #0 in the recovery room
|
The surgeon's opinion of the operative conditions, as measured using a 4 point likert scale.
|
Measured once Post-Op Day #0 in the recovery room
|
Estimated Blood Loss
Tijdsspanne: Measured once Post-Op Day #0 in the recovery room
|
Final estimated blood loss in mL for the procedure
|
Measured once Post-Op Day #0 in the recovery room
|
Total operating room time
Tijdsspanne: Measured once Post-Op Day #0 in the recovery room
|
Total number of minutes spent in the operating room
|
Measured once Post-Op Day #0 in the recovery room
|
Time to extubation
Tijdsspanne: Measured once Post-Op Day #0 in the recovery room
|
Total time from intubation to extubation
|
Measured once Post-Op Day #0 in the recovery room
|
Intraoperative fentanyl use
Tijdsspanne: Measured once Post-Op Day #0 in the recovery room
|
Total amount (in mcg) of intravenous fentanyl used during the procedure
|
Measured once Post-Op Day #0 in the recovery room
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. doi: 10.1136/bmj.321.7275.1493.
- Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int. 2006 Dec;17(12):1726-33. doi: 10.1007/s00198-006-0172-4. Epub 2006 Sep 16.
- Neuman MD, Silber JH, Elkassabany NM, Ludwig JM, Fleisher LA. Comparative effectiveness of regional versus general anesthesia for hip fracture surgery in adults. Anesthesiology. 2012 Jul;117(1):72-92. doi: 10.1097/ALN.0b013e3182545e7c.
- Minville V, Fourcade O, Grousset D, Chassery C, Nguyen L, Asehnoune K, Colombani A, Goulmamine L, Samii K. Spinal anesthesia using single injection small-dose bupivacaine versus continuous catheter injection techniques for surgical repair of hip fracture in elderly patients. Anesth Analg. 2006 May;102(5):1559-63. doi: 10.1213/01.ane.0000218421.18723.cf.
- Roche JJ, Wenn RT, Sahota O, Moran CG. Effect of comorbidities and postoperative complications on mortality after hip fracture in elderly people: prospective observational cohort study. BMJ. 2005 Dec 10;331(7529):1374. doi: 10.1136/bmj.38643.663843.55. Epub 2005 Nov 18.
- Marsh JL, Slongo TF, Agel J, Broderick JS, Creevey W, DeCoster TA, Prokuski L, Sirkin MS, Ziran B, Henley B, Audige L. Fracture and dislocation classification compendium - 2007: Orthopaedic Trauma Association classification, database and outcomes committee. J Orthop Trauma. 2007 Nov-Dec;21(10 Suppl):S1-133. doi: 10.1097/00005131-200711101-00001.
- Chu CC, Weng SF, Chen KT, Chien CC, Shieh JP, Chen JY, Wang JJ. Propensity Score-matched Comparison of Postoperative Adverse Outcomes between Geriatric Patients Given a General or a Neuraxial Anesthetic for Hip Surgery: A Population-based Study. Anesthesiology. 2015 Jul;123(1):136-47. doi: 10.1097/ALN.0000000000000695.
- Basques BA, Bohl DD, Golinvaux NS, Samuel AM, Grauer JG. General versus spinal anaesthesia for patients aged 70 years and older with a fracture of the hip. Bone Joint J. 2015 May;97-B(5):689-95. doi: 10.1302/0301-620X.97B5.35042.
- Bulka CM, Terekhov MA, Martin BJ, Dmochowski RR, Hayes RM, Ehrenfeld JM. Nondepolarizing Neuromuscular Blocking Agents, Reversal, and Risk of Postoperative Pneumonia. Anesthesiology. 2016 Oct;125(4):647-55. doi: 10.1097/ALN.0000000000001279.
- Stewart PA, Liang SS, Li QS, Huang ML, Bilgin AB, Kim D, Phillips S. The Impact of Residual Neuromuscular Blockade, Oversedation, and Hypothermia on Adverse Respiratory Events in a Postanesthetic Care Unit: A Prospective Study of Prevalence, Predictors, and Outcomes. Anesth Analg. 2016 Oct;123(4):859-68. doi: 10.1213/ANE.0000000000001513.
- Chang CC, Lin HC, Lin HW, Lin HC. Anesthetic management and surgical site infections in total hip or knee replacement: a population-based study. Anesthesiology. 2010 Aug;113(2):279-84. doi: 10.1097/ALN.0b013e3181e2c1c3.
- Zorrilla-Vaca A, Grant MC, Mathur V, Li J, Wu CL. The Impact of Neuraxial Versus General Anesthesia on the Incidence of Postoperative Surgical Site Infections Following Knee or Hip Arthroplasty: A Meta-Analysis. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):555-63. doi: 10.1097/AAP.0000000000000437.
- Mauermann WJ, Shilling AM, Zuo Z. A comparison of neuraxial block versus general anesthesia for elective total hip replacement: a meta-analysis. Anesth Analg. 2006 Oct;103(4):1018-25. doi: 10.1213/01.ane.0000237267.75543.59.
- 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.
- Holmstrom B, Laugaland K, Rawal N, Hallberg S. Combined spinal epidural block versus spinal and epidural block for orthopaedic surgery. Can J Anaesth. 1993 Jul;40(7):601-6. doi: 10.1007/BF03009695.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
19 juli 2017
Primaire voltooiing (Verwacht)
1 augustus 2019
Studie voltooiing (Verwacht)
1 augustus 2020
Studieregistratiedata
Eerst ingediend
1 mei 2017
Eerst ingediend dat voldeed aan de QC-criteria
19 juli 2017
Eerst geplaatst (Werkelijk)
21 juli 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 augustus 2019
Laatste update ingediend die voldeed aan QC-criteria
17 augustus 2019
Laatst geverifieerd
1 augustus 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 209397
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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