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The timing of administration of intravenous dexmedetomidine during lower limb surgery: a randomized controlled trial.

ABSTRACT: Dexmedetomidine, a selective alpha-2 agonist, has sedative, analgesic, and anxiolytic effects without respiratory depression. Dexmedetomidine can cause a biphasic cardiovascular response, and induce transient hypertension. Hypotension is a common complication of spinal anesthesia. Decreasing anxiety of patients before procedure is important for high quality of procedure. This study aimed to compare the incidence of hypotension and patients' anxiety and comfort levels when dexmedetomidine was intravenously administered before and after spinal anesthesia.Seventy-four patients with American Society of Anesthesiologists physical status classification I or II were randomly allocated into two groups. Spinal anesthesia was performed using 12 mg of 0.5% heavy bupivacaine. In Group A, 1 ?g/kg of dexmedetomidine was intravenously administered for 10 min, followed by the maintenance infusion of dexmedetomidine 0.2 ?g/kg/hr after 5 min of intrathecal bupivacaine injection. Patients in Group B received same dose of dexmedetomidine by intravenous administration before 5 min of intrathecal bupivacaine injection. Perioperative vital signs, anxiety (using the Spielberger's State-Trait Anxiety Inventory) and comfort (using the numerical rating scale) were evaluated.The incidence of hypotension was significantly lower in Group A (16.1%) than in Group B (48.4%) during infusion of dexmedetomidine (p?=?0.01). The need for treatment of hypotension is higher in Group B than Group A (p?=?0.02). The incidence of bradycardia and desaturation did not significantly differ between the two groups. There were no statistically significant differences regarding the patients' anxiety and comfort.Hypotension is more frequently occurred, and the treatment of hypotension is more needed in Group B. The intravenously administration of dexmedetomidine before spinal anesthesia has no advantages in hemodynamic status and patients' comfort compared to that after spinal anesthesia during lower limb surgery.ClinicalTrials.gov number, NCT02155010 . Retrospectively registered on May 22, 2014.

SUBMITTER: Kang E

PROVIDER: S-EPMC5117579 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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The timing of administration of intravenous dexmedetomidine during lower limb surgery: a randomized controlled trial.

Kang Eunsu E Lee Ki Hwa KH Jeon Sang Yoon SY Lee Kyu Won KW Ko Myoung Jin MJ Kim Hyojoong H Kim Yong Han YH Jung Jae-Wook JW

BMC anesthesiology 20161121 1

<h4>Background</h4>Dexmedetomidine, a selective alpha-2 agonist, has sedative, analgesic, and anxiolytic effects without respiratory depression. Dexmedetomidine can cause a biphasic cardiovascular response, and induce transient hypertension. Hypotension is a common complication of spinal anesthesia. Decreasing anxiety of patients before procedure is important for high quality of procedure. This study aimed to compare the incidence of hypotension and patients' anxiety and comfort levels when dexm ...[more]

PMID: 27871236

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Project description:BACKGROUND:Postoperative delirium is common in elderly cardiac surgery patients. It is multifactorial and is influenced by the patient's baseline status and the nature of the medical and surgical interventions that the patient receives. Some of these factors are potentially modifiable, including postoperative sedation and analgesia protocols. This study has been designed to evaluate the effectiveness of postoperative intravenous acetaminophen in conjunction with either dexmedetomidine or propofol in decreasing the incidence of delirium. METHODS:This is a prospective, randomized, placebo-controlled, double-blinded, factorial trial that includes patients who are at least 60 years old and who are undergoing cardiac surgeries involving cardiopulmonary bypass, including coronary artery bypass graft (CABG) and combined CABG/valve surgeries. Patients are randomly assigned to receive one of four postoperative analgesic-sedation regimens: (1) acetaminophen and dexmedetomidine, (2) acetaminophen and propofol, (3) dexmedetomidine and placebo, or (4) propofol and placebo. The primary outcome, incidence of delirium, will be assessed with the Confusion Assessment Method (CAM or CAM-ICU). The secondary outcome, postoperative cognitive decline, will be assessed with the Montreal Cognitive Assessment. Additional secondary outcomes, including duration of delirium, postoperative analgesic requirement, length of stay, and incidence of adverse events, will also be reported. Data will be analyzed in 120 randomly assigned patients who received at least one dose of the study medication(s) on a modified intention-to-treat basis. DISCUSSION:This study has been approved by the institutional review board at Beth Israel Deaconess Medical Center, and the trial is currently recruiting. This study will systematically examine the implications of modification in postoperative sedative/analgesic protocols after cardiac surgery, specifically for short- and long-term cognitive outcomes. Any positive outcomes from this study could direct simple yet effective practice changes aimed to reduce morbidity. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02546765 , registered January 13, 2015.

Project description:BackgroundInhalational anesthesia and propofol-based total intravenous anesthesia (TIVA) are the two most popular methods of general anesthesia with distinct characteristics that may affect quality of recovery (QOR) differently. This study compared QOR after corrective lower limb osteotomy between desflurane-based inhalational anesthesia and propofol-based TIVA.MethodsSixty-eight patients, ASA class I or II who underwent corrective lower limb osteotomy were randomized to receive either desflurane anesthesia or propofol TIVA. The primary outcome was quality of recovery 40 (QoR-40) questionnaire scores on postoperative day (POD) 1 and 2. Postoperative nausea scores, antiemetic requirements, and amount of opioid consumption via intravenous patient-controlled analgesia (IV PCA) were assessed as secondary outcomes.ResultsGlobal QoR-40 scores on POD 1 (153.5 (140.3, 171.3) vs. 140.0 (120.0, 173.0), P = 0.056, 95% CI; -22.5, 0.2) and POD 2 (155.5 (146.8, 175.5) vs. 152.0 (134.0, 179.0), P = 0.209, 95% CI; -17.5, 3.9) were comparable between the two groups. Among the five dimensions of QoR-40, physical independence scores were significantly higher in the TIVA group compared to the Desflurane group on POD both 1 and 2. Nausea scores (0.0 (0.0, 0.0) vs. 1.0 (0.0, 3.5), P < 0.001) and number of patients requiring rescue antiemetics (0% vs. 15.2%, P = 0.017) were significantly lower in the TIVA group at the post anesthesia care unit (PACU). Although the number of bolus attempts between 0-24 h and the morphine equivalent dose of analgesics administered via IV PCA between 12-24 h were significantly less in the TIVA group compared to the Desflurane group, there was no significant difference between groups for the overall 48 h postoperative period.ConclusionsPropofol-based TIVA did not improve global QoR-40 scores compared with desflurane-based inhalational anesthesia. However, considering the better QoR-40 scores in the domain of physical independence and less nausea in the early postoperative period, propofol TIVA should be considered as a useful option in patients undergoing corrective lower limb osteotomy.

Project description:BackgroundDexmedetomidine is a sedative agent that may have the potential to reduce the risk of post-intensive care syndrome (PICS). This study aimed to establish whether prophylactic nocturnal dexmedetomidine safely reduces postoperative PICS incidence and to develop an easy-to-use model for predicting the risk of PICS following cardiac surgery.MethodsThis was a single-center, double-blind, randomized, prospective, placebo-controlled trial. Patients undergoing cardiac surgery were randomly assigned (1:1) to dexmedetomidine or placebo (normal saline) groups between January 2019 and July 2020. Dexmedetomidine or a similar volume of saline was administered, with an infusion rate up to 1.2 μg/kg/h until the RASS remained between - 1 and 0. The primary study endpoint was PICS incidence at 6 months follow-up, as defined by cognitive, physical, or psychological impairments.ResultsWe assessed 703 individuals for eligibility, of whom 508 were enrolled. Of these, there were 251 in the dexmedetomidine group and 257 in the placebo group that received the trial agent, forming a modified intention-to-treat population. PICS incidence at 6-month follow-up was significantly decreased in the dexmedetomidine group (54/251, 21.5%) relative to the placebo group (80/257, 31.1%) (odds ratio [OR] 0.793, 95% CI 0.665-0.945; p = 0.014). Psychological impairment was significantly reduced in the dexmedetomidine group relative to the placebo group (18.7% vs. 26.8%, OR 0.806, CI 0.672-0.967, p = 0.029). However, dexmedetomidine treatment was associated with a higher rate of hypotension. A nomogram revealed that age, education, a medical history of diabetes and smoking, dexmedetomidine treatment, postoperative atrial fibrillation, and sequential organ failure assessment scores at 8 h post-surgery were independent predictors of PICS.ConclusionsProphylactic nocturnal dexmedetomidine administration significantly reduced PICS incidence by a marked reduction in psychological impairment within a 6-month follow-up period.Trial registrationChiCTR, ChiCTR1800014314 . Registered 5 January 2018, http://www.chictr.org.cn/index.aspx.

Project description:BACKGROUND:Cognitive decline after cardiac surgery occurs frequently and persists in a significant proportion of patients. Preclinical studies and human trials suggest that intravenous lidocaine may confer protection in the setting of neurologic injury. It was hypothesized that lidocaine administration would reduce cognitive decline after cardiac surgery compared to placebo. METHODS:After institutional review board approval, 478 patients undergoing cardiac surgery were enrolled into this multicenter, prospective, randomized, double-blinded, placebo-controlled, parallel group trial. Subjects were randomized to lidocaine 1?mg/kg bolus after the induction of anesthesia followed by a continuous infusion (48 ?g · kg · min for the first hour, 24 ?g · kg · min for the second hour, and 10 ?g · kg · min for the next 46?h) or saline with identical volume and rate changes to preserve blinding. Cognitive function was assessed preoperatively and at 6 weeks and 1 yr postoperatively using a standard neurocognitive test battery. The primary outcome was change in cognitive function between baseline and 6 weeks postoperatively, adjusting for age, years of education, baseline cognition, race, and procedure type. RESULTS:Among the 420 allocated subjects who returned for 6-week follow-up (lidocaine: N = 211; placebo: N = 209), there was no difference in the continuous cognitive score change (adjusted mean difference [95% CI], 0.02 (-0.05, 0.08); P = 0.626). Cognitive deficit (greater than 1 SD decline in at least one cognitive domain) at 6 weeks occurred in 41% (87 of 211) in the lidocaine group versus 40% (83 of 209) in the placebo group (adjusted odds ratio [95% CI], 0.94 [0.63, 1.41]; P = 0.766). There were no differences in any quality of life outcomes between treatment groups. At the 1-yr follow-up, there continued to be no difference in cognitive score change, cognitive deficit, or quality of life. CONCLUSIONS:Intravenous lidocaine administered during and after cardiac surgery did not reduce postoperative cognitive decline at 6 weeks.

Project description:Phantom limb pain is a prevalent condition that is difficult to manage, with a lack of robust evidence to support the use of many adjunctive treatments. Acupuncture can be effective in the management of many painful conditions but little is known about its effectiveness in treating phantom limb pain. The aim of this study is to explore the feasibility of conducting a randomized controlled trial comparing acupuncture and routine care in a group of lower limb amputees with phantom limb pain.An unstratified, pragmatic, randomized, two-armed, controlled trial of parallel design comparing acupuncture and usual care control will be conducted. A total of 20 participants will be randomly assigned to receive either usual care or usual care plus acupuncture. Acupuncture will include eight 1 hour treatments delivered pragmatically over 4 weeks by practitioners trained in traditional Chinese medicine. As outcome measures, the Numerical Pain Rating Scale, short-form McGill Pain Questionnaire 2, EQ-5D-5 L, Hospital Anxiety and Depression Scale, 10-Item Perceived Stress Scale, Insomnia Severity Index, and Patient Global Impression of Change will be completed at baseline, weekly for the duration of the study and at 1 month after completion of the study. After completion of the trial, participants will provide feedback though semi-structured interviews. Feasibility will be determined through the ability to recruit to the study, success of the randomization process, completion of acupuncture intervention, acceptability of random allocation and completion of outcome measures. Acceptability of the acupuncture intervention will be determined through semi-structured interviews with participants. The appropriateness of outcome measures for a future trial will be addressed through completion rates of questionnaires and participant feedback.Data generated on effect size will be used for future sample size calculations and will inform the development of an appropriate and feasible protocol for use in a definitive multicentre randomized controlled trial.ClinicalTrials.gov: NCT02126436.

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The timing of administration of intravenous dexmedetomidine during lower limb surgery: a randomized controlled trial.

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The timing of administration of intravenous dexmedetomidine during lower limb surgery: a randomized controlled trial.

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