Dataset Information

Efficacy of ?-Blockers on Hemodynamic Control during Pheochromocytoma Resection: A Randomized Controlled Trial.

ABSTRACT: CONTEXT:Pretreatment with ?-adrenergic receptor blockers is recommended to prevent hemodynamic instability during resection of a pheochromocytoma or sympathetic paraganglioma (PPGL). OBJECTIVE:To determine which type of ?-adrenergic receptor blocker provides the best efficacy. DESIGN:Randomized controlled open-label trial (PRESCRIPT; ClinicalTrials.gov NCT01379898). SETTING:Multicenter study including 9 centers in The Netherlands. PATIENTS:134 patients with nonmetastatic PPGL. INTERVENTION:Phenoxybenzamine or doxazosin starting 2 to 3 weeks before surgery using a blood pressure targeted titration schedule. Intraoperative hemodynamic management was standardized. MAIN OUTCOME MEASURES:Primary efficacy endpoint was the cumulative intraoperative time outside the blood pressure target range (ie, SBP >160 mmHg or MAP <60 mmHg) expressed as a percentage of total surgical procedure time. Secondary efficacy endpoint was the value on a hemodynamic instability score. RESULTS:Median cumulative time outside blood pressure targets was 11.1% (interquartile range [IQR]: 4.3-20.6] in the phenoxybenzamine group compared to 12.2% (5.3-20.2)] in the doxazosin group (P = .75, r = 0.03). The hemodynamic instability score was 38.0 (28.8-58.0) and 50.0 (35.3-63.8) in the phenoxybenzamine and doxazosin group, respectively (P = .02, r = 0.20). The 30-day cardiovascular complication rate was 8.8% and 6.9% in the phenoxybenzamine and doxazosin group, respectively (P = .68). There was no mortality after 30 days. CONCLUSIONS:The duration of blood pressure outside the target range during resection of a PPGL was not different after preoperative treatment with either phenoxybenzamine or doxazosin. Phenoxybenzamine was more effective in preventing intraoperative hemodynamic instability, but it could not be established whether this was associated with a better clinical outcome.

SUBMITTER: Buitenwerf E

PROVIDER: S-EPMC7261201 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Efficacy of α-Blockers on Hemodynamic Control during Pheochromocytoma Resection: A Randomized Controlled Trial.

Buitenwerf Edward E Osinga Thamara E TE Timmers Henri J L M HJLM Lenders Jacques W M JWM Feelders Richard A RA Eekhoff Elisabeth M W EMW Haak Harm R HR Corssmit Eleonora P M EPM Bisschop Peter H L T PHLT Valk Gerlof D GD Veldman Ronald Groote RG Dullaart Robin P F RPF Links Thera P TP Voogd Magiel F MF Wietasch Götz J K G GJKG Kerstens Michiel N MN

The Journal of clinical endocrinology and metabolism 20200701 7

<h4>Context</h4>Pretreatment with α-adrenergic receptor blockers is recommended to prevent hemodynamic instability during resection of a pheochromocytoma or sympathetic paraganglioma (PPGL).<h4>Objective</h4>To determine which type of α-adrenergic receptor blocker provides the best efficacy.<h4>Design</h4>Randomized controlled open-label trial (PRESCRIPT; ClinicalTrials.gov NCT01379898).<h4>Setting</h4>Multicenter study including 9 centers in The Netherlands.<h4>Patients</h4>134 patients with no ...[more]

PMID: 31714582

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Project description:BackgroundHemodynamic instability is frequently observed during adrenalectomy for pheochromocytoma (PCC). Guidelines recommend liberal preoperative volume administration. However, it is unclear whether fluid deficiency or vasoplegia causes shifting hemodynamics and whether minimally invasive hemodynamic monitoring with esophageal Doppler (EDM) can help visualize intraoperative changes avoiding volume overload and complications.MethodsTen patients with biochemically verified PCC and five patients with hormonally inactive adrenal tumors (HIAT; control group) were treated following a strict protocol. During laparoscopic adrenalectomy, goal-directed fluid therapy was performed using EDM. Hemodynamic and biochemical data were documented. The primary outcome variables were fluid requirement and hemodynamic parameters.ResultsApplying EDM, total intraoperative fluid administration was slightly higher in PCC patients than in patients with HIAT (2100 ± 516 vs. 1550 ± 622 ml, p = 0.097; 12.9 ± 4.8 vs. 8.3 ± 0.7 ml kg-1 h-1, p = 0.014). Hemodynamics varied considerably within the PCC group and was associated with type and level of secreted catecholamines. Arterial blood pressure and systemic vascular resistance index reached their minimum in the 10-min period after resection of PCC. Without liberal fluid administration, an increase in cardiac index was observed in both groups comparing baseline measurements to end of surgery. This increase was statistically significant only in PCC patients (PCC: 2.31 vs. 3.15 l min-1 m-2, p = 0.005; HIAT: 2.08 vs. 2.56 l min-1 m-2, p = 0.225).ConclusionsAs vasoplegia, but not hypovolemia, was documented after tumor resection, there is no evidence that PCC patients profit from liberal fluid administration during laparoscopic adrenalectomy. To avoid volume overload, noninvasive techniques such as EDM should be routinely used to visualize the variable intraoperative course.Trial registrationClinicalTrials.gov, Identifier: NCT01425710.

Project description:BACKGROUND:Use of minimally invasive surgical techniques for lung resection surgery (LRS), such as video-assisted thoracoscopy (VATS), has increased in recent years. However, there is little information about the best anesthetic technique in this context. This surgical approach is associated with a lower intensity of postoperative pain, and its use has been proposed in programs for enhanced recovery after surgery (ERAS). This study compares the severity of postoperative complications in patients undergoing LRS who have received lidocaine intraoperatively either intravenously or via paravertebral administration versus saline. METHODS/DESIGN:We will conduct a single-center randomized controlled trial involving 153 patients undergoing LRS through a thoracoscopic approach. The patients will be randomly assigned to one of the following study groups: intravenous lidocaine with more paravertebral thoracic (PVT) saline, PVT lidocaine with more intravenous saline, or intravenous remifentanil with more PVT saline. The primary outcome will be the comparison of the postoperative course through Clavien-Dindo classification. Furthermore, we will compare the perioperative pulmonary and systemic inflammatory response by monitoring biomarkers in the bronchoalveolar lavage fluid and blood, as well as postoperative analgesic consumption between the three groups of patients. We will use an ANOVA to compare quantitative variables and a chi-squared test to compare qualitative variables. DISCUSSION:The development of less invasive surgical techniques means that anesthesiologists must adapt their perioperative management protocols and look for anesthetic techniques that provide good analgesic quality and allow rapid rehabilitation of the patient, as proposed in the ERAS protocols. The administration of a continuous infusion of intravenous lidocaine has proven to be useful and safe for the management of other types of surgery, as demonstrated in colorectal cancer. We want to know whether the continuous administration of lidocaine by a paravertebral route can be substituted with the intravenous administration of this local anesthetic in a safe and effective way while avoiding the risks inherent in the use of regional anesthetic techniques. In this way, this technique could be used in a safe and effective way in ERAS programs for pulmonary resection. TRIAL REGISTRATION:EudraCT, 2016-004271-52; ClinicalTrials.gov, NCT03905837 . Protocol number IGGFGG-2016 version 4.0, 27th April 2017.

Project description:Major abdominal surgery is associated with significant risk of morbidity and mortality in the perioperative period. Optimising intraoperative fluid administration may result in improved outcomes. Our aim was to compare the effects of central venous pressure (CVP), and central venous oxygen saturation (ScvO2)-assisted fluid therapy on postoperative complications in patients undergoing high risk surgery.Patients undergoing elective major abdominal surgery were randomised into control and ScvO2 groups. The target level of mean arterial pressure (MAP) was???60 mmHg in both groups. In cases of MAP?<?60 mmHg patients received either a fluid or vasopressor bolus according to the CVP?<?8 mmHg in the control group. In the ScvO2 group, in addition to the MAP, an ScvO2 of <75% or a >3% decrease indicated need for intervention, regardless of the actual MAP. Data are presented as mean?±?standard deviation or median (interquartile range).We observed a lower number of patients with complications in the ScvO2 group compared to the control group, however it did not reach statistical significance (ScvO2 group: 10 vs.19; p?=?0.07). Patients in the ScvO2 group (n?=?38) received more colloids compared to the control group (n?=?41) [279(161) vs. 107(250) ml/h; p?<?0.001]. Both groups received similar amounts of crystalloid (1126?±?471 vs. 1049?±?431 ml/h; p?=?0.46) and norepinephrine [37(107) vs. 18(73) mcg/h; p?=?0.84]. Despite similar blood loss in both groups, the ScvO2 group received more blood transfusions (63% vs. 37%; p?=?0.018). More patients in the control group had a postoperative PaO2/FiO2?<?200 mmHg (23 vs. 10, p?<?0.01). Twenty eight day survival was significantly higher in the ScvO2 group (37/38 vs. 33/41 p?=?0.018).ScvO2-assisted intraoperative haemodynamic support provided some benefits, including significantly better postoperative oxygenation and 28 day survival rate, compared to CVP-assisted therapy without a significant effect on postoperative complications during major abdominal surgery.ClinicalTrials.gov NCT02337010.

Project description:BackgroundSome children feel pain during wound closures using tissue adhesives. We sought to determine whether a topically applied analgesic solution of lidocaine-epinephrine-tetracaine would decrease pain during tissue adhesive repair.MethodsWe conducted a randomized, placebo-controlled, blinded trial involving 221 children between the ages of 3 months and 17 years. Patients were enrolled between March 2011 and January 2012 when presenting to a tertiary-care pediatric emergency department with lacerations requiring closure with tissue adhesive. Patients received either lidocaine-epinephrine-tetracaine or placebo before undergoing wound closure. Our primary outcome was the pain rating of adhesive application according to the colour Visual Analogue Scale and the Faces Pain Scale--Revised. Our secondary outcomes were physician ratings of difficulty of wound closure and wound hemostasis, in addition to their prediction as to which treatment the patient had received.ResultsChildren who received the analgesic before wound closure reported less pain (median 0.5, interquartile range [IQR] 0.25-1.50) than those who received placebo (median 1.00, IQR 0.38-2.50) as rated using the colour Visual Analogue Scale (p=0.01) and Faces Pain Scale--Revised (median 0.00, IQR 0.00-2.00, for analgesic v. median 2.00, IQR 0.00-4.00, for placebo, p<0.01). Patients who received the analgesic were significantly more likely to report having or to appear to have a pain-free procedure (relative risk [RR] of pain 0.54, 95% confidence interval [CI] 0.37-0.80). Complete hemostasis of the wound was also more common among patients who received lidocaine-epinephrine-tetracaine than among those who received placebo (78.2% v. 59.3%, p=0.008).InterpretationTreating minor lacerations with lidocaine-epinephrine-tetracaine before wound closure with tissue adhesive reduced ratings of pain and increased the proportion of pain-free repairs among children aged 3 months to 17 years. This low-risk intervention may benefit children with lacerations requiring tissue adhesives instead of sutures.Trial registrationClinicalTrials.gov, no. PR 6138378804.

Dataset Information

Efficacy of ?-Blockers on Hemodynamic Control during Pheochromocytoma Resection: A Randomized Controlled Trial.

Publications

Efficacy of α-Blockers on Hemodynamic Control during Pheochromocytoma Resection: A Randomized Controlled Trial.

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