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Oral Midodrine Hydrochloride for Prevention of Orthostatic Oral Midodrine Hydrochloride for Prevention of Orthostatic Hypotension during Early Mobilization after Hip Arthroplasty A Randomized, Double-blind, Placebo-controlled Trial Øivind Jans, M.D., Ph.D., Jesper Mehlsen, M.D., Per Kjærsgaard-Andersen, M.D., Henrik Husted, M.D., D.M.Sc., Søren Solgaard, M.D., D.M.Sc., Jakob Josiassen, M.S., Troels Haxholdt Lunn, M.D., Ph.D., Henrik Kehlet, M.D., Ph.D. ABSTRACT Downloaded from http://pubs.asahq.org/anesthesiology/article-pdf/123/6/1292/372945/20151200_0-00021.pdf by guest on 25 September 2021 Background: Early postoperative mobilization is essential for rapid recovery but may be impaired by orthostatic intolerance (OI) and orthostatic hypotension (OH), which are highly prevalent after major surgery. Pathogenic mechanisms include an insufficient postoperative vasopressor response. The oral α-1 agonist midodrine hydrochloride increases vascular resistance, and the authors hypothesized that midodrine would reduce the prevalence of OH during mobilization 6 h after total hip arthroplasty relative to placebo. Methods: This double-blind, randomized trial allocated 120 patients 18 yr or older and scheduled for total hip arthroplasty under spinal anesthesia to either 5 mg midodrine hydrochloride or placebo orally 1 h before mobilization at 6 and 24 h post- operatively. The primary outcome was the prevalence of OH (decrease in systolic or diastolic arterial pressures of > 20 or 10 mmHg, respectively) during mobilization 6 h after surgery. Secondary outcomes were OI and hemodynamic responses to mobilization at 6 and 24 h. Results: At 6 h, 14 (25%; 95% CI, 14 to 38%) versus 23 (39.7%; 95% CI, 27 to 53%) patients had OH in the midodrine and placebo group, respectively, relative risk 0.63 (0.36 to 1.10; P = 0.095), whereas OI was present in 15 (25.0%; 15 to 38%) versus 22 (37.3%; 25 to 51%) patients, relative risk 0.68 (0.39 to 1.18; P = 0.165). At 24 h, OI and OH prevalence did not differ between groups. Conclusions: Preemptive use of oral 5 mg midodrine did not significantly reduce the prevalence of OH during early postop- erative mobilization compared with placebo. However, further studies on dose and timing are warranted since midodrine is effective in chronic OH conditions. ( ANESTHESIOLOGY 2015; 123:1292-300) ARLY postoperative mobilization is essential to avoid E postoperative morbidity and in ensuring early recov- What We Already Know about This Topic ery. 1,2 Thus, early postoperative mobilization, often on • The oral α1-adrenergic agonist, midodrine, is effective in treat- the day of surgery, has become an integral part of several ment of chronic orthostatic hypotension • Orthostatic hypotension is common during early mobilization “fast-track” or “enhanced-recovery” protocols, which reduce after surgery and interferes with recovery, but the effects of postoperative morbidity and hospital length of stay (LOS).3 midodrine in this population have not been tested However, early postoperative mobilization may be hindered What This Article Tells Us That Is New by orthostatic hypotension (OH), defined as a decrease in systolic arterial pressure (SAP) greater than 20 mmHg or • In 120 patients undergoing total hip arthroplasty, administration 4 of 5 mg midodrine 1 h before early mobilization at 6 h after sur- diastolic arterial pressure (DAP) greater than 10 mmHg, gery did not reduce the incidence of orthostatic hypotension and orthostatic intolerance (OI) defined as symptoms such • Further studies examining other doses and timing are war- as dizziness, nausea, vomiting, blurred vision, or syncope ranted during mobilization.5,6 The prevalence of OI and OH dur- ing mobilization 6 h after surgery has been reported to be prostatectomy8,9 and was associated with a prolonged LOS.9 as high 40 and 50%, respectively, after hip arthroplasty.7 In The use of perioperative goal-directed fluid therapy did not addition, OI occurred in up to 60% of patients 6 h after reduce OI during early mobilization,9 whereas an attenuated This article is featured in “This Month in Anesthesiology,” page 3A. James C. Eisenach, M.D., served as Handling Editor for this article. Submitted for publication May 28, 2015. Accepted for publication August 10, 2015. From the Section of Surgical Pathophysiology, The Juliane Marie Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark (Ø.J., J.J., T.H.L., H.K.); Coordinating Research Centre, Frederiksberg Hospital, Frederiksberg, Denmark (J.M.); Department of Orthopedic Surgery, Vejle Sygehus, Vejle, Denmark (P.K.-A.); Departments of Orthopedic Surgery (H.H.) and Anesthesia (T.H.L.), Hvidovre Hospital, Hvidovre, Denmark; Department of Orthopedic Surgery, Gentofte Hospital, Hellerup, Denmark (S.S.); and The Lundbeck Centre for Fast-Track Hip and Knee Arthroplasty, Copenhagen, Denmark (Ø.J., T.H.L., H.K.). Copyright © 2015, the American Society of Anesthesiologists, Inc. Wolters Kluwer Health, Inc. All Rights Reserved. Anesthesiology 2015; 123:1292-300 Anesthesiology, V 123 • No 6 1292 December 2015 Copyright © 2015, the American Society of Anesthesiologists, Inc. Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited. PERIOPERATIVE MEDICINE postural vasopressor response early after surgery may be an urinary retention requiring treatment, history of recurrent important contributing factor.7–9 OI/hypotension, known autonomous nervous system dis- The oral α1-adrenoreceptor agonist midodrine hydro- ease, alcohol or drug abuse, current active malignant disease, chloride is a prodrug for desglymidodrine that acts directly premenopausal women, treatment with vitamin-K antago- on peripheral arteriolar and venous vasculature, thereby nists, body mass index greater than 40 kg/m2, dementia, cog- increasing the systemic vascular resistance.10 Midodrine nitive dysfunction, or participation in other trials. Patients is used for treating recurrent symptomatic OH and OI were recruited through the participating clinics. Screening in patients with various forms of autonomic failure11 and for eligibility, enrollment, and allocation of patients was car- has, in several randomized controlled trials, demonstrated a ried out by dedicated research nurses at each participating reduction in OI symptoms and an improvement in the abil- hospital. ity to stand compared with placebo.12–14 In addition, a 5-mg Downloaded from http://pubs.asahq.org/anesthesiology/article-pdf/123/6/1292/372945/20151200_0-00021.pdf by guest on 25 September 2021 midodrine dose administered 1 h before head-up-tilt (HUT) Randomization, Trial Intervention, and Blinding markedly reduced the prevalence of HUT-induced neurally Patients were randomly assigned to receive an oral mediated syncope.15 administration of either 5 mg midodrine hydrochloride Therefore, we hypothesized that midodrine may or placebo at 5 and 23 h after surgery (1 h before mobili- ameliorate the postoperatively attenuated postural vaso- zation at 6 and 24 h postoperatively). The Capital Region pressor response and prevent postoperative OH. Con- pharmacy (Herlev, Denmark), prepared the study drug; sequently, in this double-blind, placebo-controlled, generated the randomization list (1:1 allocation ratio); randomized trial, we investigated whether the preemp- and prepared sequentially numbered, opaque, sealed tive administration of 5 mg midodrine hydrochloride envelopes that were distributed directly to the participat- could reduce the prevalence of OH and OI during early ing centers. To ensure balance in the number of patients postoperative mobilization 6 and 24 h after total hip for each allocation group at each site, block random- arthroplasty (THA). ization with a block size of 10 was performed. To pre- serve concealment, both midodrine hydrochloride and Material and Methods placebo were placed in identical capsules and packed in one container per patient labeled with the allocated ran- Trial Design and Oversight domization number. All participating patients, hospital The study was a three-center, double-blinded, placebo- personnel, outcome assessors, and trial investigators were controlled, superiority trial and was conducted according blinded to allocation group. After study termination, the to the International Conference on Harmonization guide- blinded randomization list was dispatched by the Capital lines for Good Clinical Practice (GCP) and was approved Regional Pharmacy to the principal investigator enabling by the ethics Committee for the Capital Region of Denmark blinded analyses. This list was unblinded with respect to (H-4-2012-097), the Danish Data Protection Agency, and intervention type only after all statistical analyses had the Danish National Board of Health (EudraCT 2012- been carried out. 002572-13) and registered on ClinicalTrials.gov under the U.S. National Library of Medicine on October 10, 2015 Anesthesia and Surgery (NCT01707953, principal investigator: Ø.J.). The trial was All patients were anesthetized by spinal anesthesia with monitored by the GCP units of the Copenhagen University bupivacaine 5 mg/ml at a maximum dose of 15 mg (3 ml) Hospital, Copenhagen, Denmark, and Odense University and operated using a standard posterolateral approach. Hospital, Odense, Denmark, and was carried out in three Propofol sedation (1 to 5 mg kg−1 h−1) was administered high-volume orthopedic surgical centers in Denmark with at the discretion of the attending anesthesiologist. One more than 500 THA procedures per year. Oral and writ- gram tranexamic acid was administered intravenously ten informed consent was
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