Background:The aim of this clinical study was to evaluate the efficacy of neurobehavioral, hemodynamics and sedative characteristics of dexmedetomidine compared with morphine and midazolam-based regimen after cardiac surgery at equivalent levels of sedation and analgesia in improving clinically relevant outcomes such as delirium.Methods:Sixty patients were randomly allocated into one of two equal groups: group A = 30 patients received dexmedetomidine infusion (0.4–0.7 μg/kg/h) and Group B = 30 patients received morphine in a dose of 10–50 μg/kg/h as an analgesic with midazolam in a dose of 0.05 mg/kg up to 0.2 mg/kg as a sedative repeated as needed. Titration of the study medication infusions was conducted to maintain light sedation (Richmond agitation-sedation scale) (−2 to +1). Primary outcome was the prevalence of delirium measured daily through confusion assessment method for intensive care.Results:Group A was associated with shorter length of mechanical ventilation, significant shorter duration of intensive care unit (ICU) stay (P = 0.038), and lower risk of delirium following cardiac surgery compared to Group B. Group A showed statistically significant decrease in heart rate values 4 h after ICU admission (P = 0.015) without significant bradycardia. Group A had lower fentanyl consumption following cardiac surgery compared to Group B.Conclusion:Dexmedetomidine significantly reduced the length of stay in ICU in adult cardiac surgery with no significant reduction in the incidence of postoperative delirium compared to morphine and midazolam.
Background:Patients’ surgical experiences are influenced by their perception of pain management. Duloxetine (Dulox) and dexamethasone (Dex) are used in multimodal analgesia to reduce opioid use and side effects. Dulox is a selective serotonin and norepinephrine reuptake inhibitor and has efficacy in chronic pain conditions. Dex enhances postoperative (PO) analgesia and reduces PO nausea and vomiting (PONV).Methods:Seventy-five female patients were randomly allocated into one of three equal groups. GI received Dulox 60 mg orally and 100 ml 0.9% sodium chloride (normal saline [NS]) intravenous infusion (IVI) over 15 min, GII: received as GI except Dex 0.1 mg/kg was mixed with NS and GIII received identical placebo for Dulox capsule and Dex IVI, 2 h preoperatively. Patients’ vitals, visual analog scale (VAS), and sedation score were assessed at 30 min, 1 h, 2 h, 6 h, and 12 h postoperatively. Total pethidine requirements, plasma cortisol, PONV, and patients satisfaction were recorded.Results:PO time for 1st rescue analgesic was significantly high in GI and GII compared to GIII and in GII compared to GI. There was a significant less VAS score, heart rate, mean arterial pressure, and a high sedation score in GI and GII compared to GIII at 30 min, 1, 2, and 6 h postoperatively. Total pethidine requirements were significantly less in GI and GII compared to GIII 12 h postoperatively. There was a significant reduction in the 2 h PO serum cortisol (μg/dl) and a significant increase in the PO patients satisfaction score in GI and GII compared to GIII. PONV was decreased significantly in GII compared to GI and GIII.Conclusion:The use of oral Dulox 60 mg combined with Dex 0.1 mg/kg IVI is more effective than oral Dulox 60 mg alone, 2 h preoperatively, for improving PO pain by reducing the requirements for rescue analgesia and PONV.
Background Post-spinal anesthesia (PSA) hypotension in elderly patients is challenging. Correction of PSA hypotension by fluids either colloids or crystalloids or by vasoconstrictors pose the risk of volume overload or compromising cardiac conditions. Dexamethasone is used to treat conditions manifested by decrease of peripheral vascular resistance. The research team was the first to test the hypothesis of its role in preventing or decreasing the incidence of PSA hypotension. Methods One hundred ten patients, aged 60 years or more were recruited to receive a single preoperative dose of dexamethasone 8 mg IVI in 100 ml normal saline (D group) (55 patients) 2 h preoperatively, and 55 patients were given placebo (C group) in a randomized, double-blind trial. Variations in blood pressure and heart rate in addition to the needs of ephedrine and/or atropine following spinal anesthesia (SA) were recorded. SA was achieved using subarachnoid injection of 3 ml hyperbaric bupivacaine 0.5%. Results Demographic data and the quality of sensory and motor block were comparable between groups. At 5th, 10th minutes post SA; systolic, diastolic and mean arterial pressures were statistically significant higher in D group. At 20th minutes post SA; the obtained blood pressure readings and heart rate changes didn’t show any statistically significance between groups. The need for ephedrine and side effects were statistically significant lower in D group than C group. Conclusion Post-spinal anesthesia hypotension, nausea, vomiting and shivering in elderly patients were less common after receiving a single preoperative dose of dexamethasone 8 mg IVI than control. Registration number ClinicalTrials.gov Identifier: NCT 03664037, Registered 17 September 2018 - Retrospectively registered, http://www.ClinicalTrial.gov
The Vigileo-FloTrac system High-risk patients Major abdominal surgeries Postoperative Morbidity Mortality a b s t r a c tBackground: This study evaluated impact of intraoperative goal-directed therapy (GDT) judged by changes of stroke volume variation (SVV) and cardiac index (CI) using the Vigileo/FloTrac system on postoperative (PO) morbidities and mortality rates in high risk patients scheduled for major abdominal surgeries in comparison to conventional fluid therapy (CT). Methods: 86 patients were randomly allocated into one of two equal groups: CT group = 43 patients received crystalloid solution and on demand bolus of 250 ml colloids with possible addition of vasopressor or inotrope to target MAP at 60-90 mmHg, CVP at 8-12 mmHg and urine output at >0.5 ml/kg/hr and GDT group = 43 patients received crystalloid fluid therapy (FT) and colloids (3 ml/kg) with possible addition of vasopressor or inotrope according to predefined protocol with a target CI 2.5 L/min/m 2 , SVV < 12% with MAP > 65 mmHg. Physiological and Operative Severity Score for Enumeration of Mortality and Morbidity (POSSUM) was used to predict morbidity and mortality rates. Study outcomes included ICU and total hospital morbidity and mortality rates and length of stay (LOS). Results: Intraoperative GDT reduced ICU morbidity rate (16.3%) than the POSSUM predicted rate (39.78%) and significantly (p = 0.039) than CT group (37.2%), while in CT group ICU morbidity rate coincided with POSSUM predicted rate (42.86%). ICU and total hospital LOS were significantly shorter with GDT group than with CT group. However, mortality rates weren't significantly lower with GDT group than CT group (7% vs. 11.6%). The applied protocol for intraoperative GDT reduced significantly crystalloid infusion and despite of significantly higher amount of received colloids, the total amount of FT was significantly less than CT group. Conclusion: The applied protocol for intraoperative GDT provided significant reduction of PO morbidities, ICU and hospital LOS but couldn't significantly reduce mortality rates in high risk patients scheduled for major abdominal surgeries.
Background. Critically ill patients have an increased requirement for vitamin C in sepsis and these patients have low levels of vitamin C. The researchers validated the efficacy of high-dose vitamin C intravenous infusion (IVI) in patients with sepsis requiring mechanical ventilation. Methods. Forty patients were randomly assigned to 2 groups (20 each) in a 1 : 1 ratio in accordance with the vitamin C treatment regimen: Group I (GI): patients received 1.5 g/6 h vitamin C in 50 ml of dextrose 5% in water (D5W) IVI over 30 minutes for 4 consecutive days; Group II (GII): patients received 100 mg vitamin C/day as a first single dose in 50 ml of D5W IVI over 30 minutes and the other three subsequent doses were 50 ml of plain D5W IVI over 30 minutes for 4 consecutive days. Primary outcomes were the change in sequential organ failure assessment (SOFA) score at day 7, the incidence of ventilator-associated pneumonia (VAP), and the plasma vitamin C level. The glutathione peroxidase (GPX) activity, C-reactive protein (CRP) level, duration of vasopressor therapy, and 28-day mortality were secondary outcomes. Results. The change in SOFA score at day 7 showed a significant difference between GI and GII ( p < 0.001 ). The incidence of early VAP was significantly lower in GI ( p = 0.044 ). Vitamin C levels showed a significant rise in GI at day 1 and day 4 ( p < 0.001 and p < 0.001 , respectively). GPX activity of day 4 and day 7 was significantly higher in GI ( p = 0.005 and p = 0.014 , respectively). CRP levels of day 4 and day 7 were significantly higher in GII ( p < 0.001 and p < 0.001 , respectively). There was a significant difference in 28-day mortality ( p = 0.038 ) and duration of vasopressor therapy ( p = 0.033 ) in GI compared to GII. Conclusion. The early use of high-dose vitamin C intravenous infusion in patients with sepsis requiring mechanical ventilation in combination with the standard treatment for sepsis lowered the incidence of VAP, increased the antioxidant status, and improved the illness severity. Trial Registration. This trial is registered with ClinicalTrials.gov Identifier (NCT04029675).
Background Shivering is known to be a frequent complication in patients undergoing surgery under neuraxial anesthesia with incidence of 40–70%. Although many pharmacological agents have been used to treat or prevent postspinal anesthesia shivering (PSAS), the ideal treatment wasn’t found. This study evaluated the efficacy of paracetamol and dexamethasone to prevent PSAS in patients undergoing lower abdominal and lower limb surgeries. Methods Three hundred patients scheduled for surgeries under spinal anesthesia (SA) were allocated into three equal groups to receive a single preoperative dose of oral paracetamol 1 g (P group), dexamethasone 8 mg intravenous infusion (IVI) in 100 ml normal saline (D group) or placebo (C group), 2 h preoperatively, in a randomized, double-blind trial. The primary endpoint was the incidence of clinically significant PSAS. Secondary endpoints included shivering score, the change in hemodynamics, adverse events (e.g., nausea, vomiting and pruritis) and patients` satisfaction. Results Clinically significant PSAS was recorded as (15%) in P group, (40%) in D group and (77%) in C group (P < 0.001). The mean blood pressure values obtained over a 5-25 min observation period were significantly higher in the D group (P < 0.001). Core temperature 90 min after SA was significantly lower in the 3 groups compared to prespinal values (P < 0.001). Nausea, vomiting and pruritis were significantly higher in the C group (P < 0.001). P and D groups were superior to C group regarding the patients’ satisfaction score (P < 0.001). Conclusion Paracetamol and dexamethasone were effective in prevention of PSAS in patients undergoing lower abdominal and lower limb surgeries compared to placebo controls. Trial registration ClinicalTrials.gov Identifier: NCT03679065 / Registered 20 September 2018 - Retrospectively registered, http://www.ClinicalTrial.gov.
Background. The frequency of shivering regarding regional anesthesia is 55%. Newer effective and tolerable options for postspinal anesthesia shivering (PSAS) prophylaxis are necessary to improve patients’ quality of care. This research assessed the impact of preemptive mirtazapine versus preemptive dexamethasone to decrease frequency and severity of PSAS in gynecological procedures. Methods. 300 patients booked for gynecological procedures under spinal anesthesia (SA) were randomly apportioned into three groups (100 each) to get one preemptive dose of 30 mg mirtazapine tablet (M group), 8 mg dexamethasone diluted in 100 ml of saline infusion (D group) or placebo (C group) two hours before surgery. Incidence of clinically significant PSAS was the primary outcome. Core temperature, shivering score, hemodynamics changes, adverse events, and patient satisfaction score were documented as secondary outcomes. Results. Compared with C group, mirtazapine and dexamethasone decreased incidence of clinically significant shivering (74% vs. 16% and 31%, respectively; P < 0.001 ). M and D groups had less hypotensive episodes during 5–25 min after intrathecal injection ( P < 0.001 ). 90 min after SA, tympanic temperatures were lower than baseline values in the three groups ( P < 0.001 ). Pruritus, nausea, and vomiting were more often in C group ( P < 0.001 ), whereas sedation was more frequent in M group ( P < 0.001 ). C group had the lowest satisfaction scores ( P < 0.001 ). Conclusion. Prophylactic administration of mirtazapine or dexamethasone attenuated shivering with minimal hazards in patients scheduled for gynecological surgeries under spinal anesthesia with priority to mirtazapine. The trial is registered with NCT03675555.
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