Preoperative Amlodipine Is More Efficacious Than Prazosin in Preventing Intraoperative Haemodynamic Instability in Pheochromocytoma/Paraganglioma Patients: Interim Analysis of a Pilot Randomized Controlled Study

Abstract Background: Preoperative blockade with α-blockers is recommended in patients with pheochromocytoma/paraganglioma (PPGL). The data on calcium channel blockade (CCB) in PPGL is scarce. We aim to compare the efficacy of CCB and α-blockers on intraoperative haemodynamic instability (HDI) in PPGL. Methods: In the interim analysis of this monocentric, pilot, open-label, randomized controlled trial, patients with solitary, secretory, and nonmetastatic PPGL were randomized to oral prazosin (maximum 30mg, n=9) or amlodipine (maximum 20mg, n=11). The primary outcomes were the episodes and duration of hypertension (SBP≥160mmHg) and hypotension (MAP<60mmHg) and duration of HDI (hypertension and/or hypotension) as a percentage of total surgical time (from induction of anaesthesia to skin closure). Findings: The median (IQR) episodes (2 [1–3] vs. 0 [0–1], p 0·002) and duration of hypertension (19 [14–42] min vs. 0 [0–3] min, p 0·001) and intraoperative HDI duration (22·85±18.4% vs 2·44±2·4%, CI 8·68-32·14%, p 0·002) were significantly higher in the prazosin arm than the amlodipine arm whereas episodes and duration of hypotension did not differ between the two groups. There was no perioperative mortality whereas one patient had intraoperative ST depression on the electrocardiogram. The drug-related adverse effects were pedal edema (1 in amlodipine), dizziness (1 in prazosin), and tachycardia (6 in prazosin and 3 in amlodipine). Interpretation: Preoperative blockade with amlodipine was more efficacious than prazosin in preventing intraoperative HDI in PPGL. Larger studies that compare preoperative blockade with amlodipine and both competitive and noncompetitive α-blockers inPPGL patients of various biochemical phenotypes are warranted.

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Preoperative amlodipine is efficacious in preventing intraoperative HDI in pheochromocytoma- pilot RCT

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/clinem/dgab231 ◽

2021 ◽

Author(s):

Sanjeet Kumar Jaiswal ◽

Saba Samad Memon ◽

Anurag Lila ◽

Vijaya Sarathi ◽

Manjunath Goroshi ◽

...

Keyword(s):

Controlled Trial ◽

Haemodynamic Instability ◽

Skin Closure ◽

Open Label ◽

Surgical Time ◽

Perioperative Mortality ◽

St Depression ◽

Pilot Rct ◽

Pedal Edema ◽

Induction Of Anaesthesia

Abstract Background Preoperative blockade with α-blockers is recommended in patients with pheochromocytoma/paraganglioma (PPGL). The data on calcium channel blockade (CCB) in PPGL is scarce. We aimed to compare the efficacy of CCB and α-blockers on intraoperative haemodynamic instability (HDI) in PPGL. Methods In the interim analysis of this monocentric, pilot, open-label, randomized controlled trial, patients with solitary, secretory, and nonmetastatic PPGL were randomized to oral prazosin GITS (maximum 30mg, n=9) or amlodipine (maximum 20mg, n=11). The primary outcomes were the episodes and duration of hypertension (SBP≥160mmHg) and hypotension (MAP<60mmHg) and duration of HDI (hypertension and/or hypotension) as a percentage of total surgical time (from induction of anaesthesia to skin closure). Findings The median (IQR) episodes (2 [1-3] vs. 0 [0-1], p 0·002) and duration of hypertension (19 [14-42] min vs. 0 [0-3] min, p 0·001) and intraoperative HDI duration (22·85±18.4% vs 2·44±2·4%, CI 8·68–32·14%, p 0·002) were significantly higher in the prazosin GITS arm than the amlodipine arm whereas episodes and duration of hypotension did not differ between the two groups. There was no perioperative mortality whereas one patient had intraoperative ST depression on the electrocardiogram. The drug-related adverse effects were pedal edema (1 in amlodipine), dizziness (1 in prazosin GITS), and tachycardia (6 in prazosin GITS and 3 in amlodipine). Interpretation Preoperative blockade with amlodipine is an efficacious alternative to prazosin GITS in preventing intraoperative HDI in PPGL. Larger studies that compare preoperative blockade by amlodipine with other α-blockers like phenoxybenzamine and/or doxazosin in PPGL patients are warranted.

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Randomized Comparison of Subcuticular Sutures Versus Staples for Skin Closure After Open Abdominal Surgery: a Multicenter Open-Label Randomized Controlled Trial

Journal of Gastrointestinal Surgery ◽

10.1007/s11605-016-3283-z ◽

2016 ◽

Vol 20 (12) ◽

pp. 2083-2092 ◽

Cited By ~ 9

Author(s):

Kazuhiro Imamura ◽

Kensuke Adachi ◽

Ritsuko Sasaki ◽

Satoko Monma ◽

Sadaaki Shioiri ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Abdominal Surgery ◽

Controlled Trial ◽

Skin Closure ◽

Open Label ◽

Randomized Controlled ◽

Open Abdominal Surgery

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Comparison of skin closure technique with stapler and subcuticular suture in patients with inguinal hernia undergoing lichtenstein tension-free mesh repair – An open-label randomized controlled trial

International Journal of Advanced Medical and Health Research ◽

10.4103/ijamr.ijamr_27_20 ◽

2020 ◽

Vol 7 (1) ◽

pp. 27

Author(s):

Vikram Kate ◽

Sathasivam Sureshkumar ◽

Datta Souraja ◽

Elangovan Archana ◽

Sahla Sathar ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Inguinal Hernia ◽

Mesh Repair ◽

Controlled Trial ◽

Skin Closure ◽

Open Label ◽

Closure Technique ◽

Subcuticular Suture ◽

Tension Free ◽

Randomized Controlled

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Prospective randomized controlled trial comparing the efficacy and safety of Roux-en-Y gastric bypass and one-anastomosis gastric bypass (the RYSA trial): trial protocol and interim analysis

Trials ◽

10.1186/s13063-019-3898-y ◽

2019 ◽

Vol 20 (1) ◽

Author(s):

Tuure Saarinen ◽

Sanna Meriläinen ◽

Vesa Koivukangas ◽

Kirsi Hannele Pietiläinen ◽

Anne Juuti

Keyword(s):

Gastric Bypass ◽

Interim Analysis ◽

Controlled Trial ◽

Bile Reflux ◽

Subcutaneous Fat ◽

University Hospital ◽

One Anastomosis Gastric Bypass ◽

Controlled Study ◽

Trial Protocol ◽

Randomized Controlled

Abstract Introduction There is a lack of prospective studies comparing Roux-en-Y gastric bypass (RYGB) and one-anastomosis gastric bypass (OAGB). Also, the effects of bariatric surgery and weight loss need a deeper understanding through metabolic studies. We describe the trial protocol and interim analysis of a prospective randomized controlled study comparing RYGB and OAGB: the RYSA trial. Materials and methods In total, 120 bariatric patients will be randomized between RYGB and OAGB in two academic centers. All patients will be followed up for 10 years with analysis and measurements of weight, comorbidities, blood tests, body composition and questionnaires. Extensive metabolic analyses (mixed meal tests, energy expenditure, biopsies of muscle and subcutaneous fat, urine, saliva and fecal samples) will be carried out in the Obesity Research Unit, University of Helsinki, for all patients treated at the Helsinki University Hospital (80 patients) at baseline, 6 months and 12 months. Bile reflux will be studied for the OAGB group at the Helsinki University Hospital at 6 months with gastroscopy and scintigraphy. Results At an interim analysis at 3 months (half-way) through recruitment (30 RYGB and 30 OAGB patients) there have been no deaths and no intensive care unit admittances. One patient in both groups required additional gastroscopy, with anastomosis dilatation in the RYGB group but with no additional intervention in the OAGB group. Conclusion The trial can be safely carried out. Recruitment is estimated to be complete by the end of 2019. Trial registration Clinical Trials Identifier NCT02882685. Registered on August 30th 2016.

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