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Major Abdominal Surgery clinical trials

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NCT ID: NCT02361060 Completed - Clinical trials for Major Abdominal Surgery

Effects of Neuromuscular Block Reversal With Sugammadex vs Neostigmine on Postoperative Respiratory Outcomes After Major Abdominal Surgery

Start date: February 2015
Phase: Phase 4
Study type: Interventional

Pulmonary complications are relatively frequent after surgery, and can be associated with an increase in morbidity and mortality. Although there are several causative mechanisms that can lead to postoperative pulmonary complications, alterations in the shape and motion of the chest wall are of primary importance. In the investigator´s institution the incidence of postoperatory hypoxemia defined as pO2/FiO2 <300 is over 20% for patients after major abdominal surgery. Observational and randomized clinical trials have demonstrated that incomplete neuromuscular recovery during the early postoperative period may result in acute respiratory events (hypoxemia and airway obstruction) and an increased risk of postoperative pulmonary complications. A recent study in laparoscopic bariatric surgery showed that patients in which neuromuscular block reversal was done with sugammadex had less chest X-ray pathological changes than those from an historical cohort reversed with neostigmine. The hypothesis is that differences in pulmonary complications, as atelectasis and hypoxemia, between patients reverted with sugammadex or neostigmine may be more apparent with more sensitive techniques like spirometry or lung ultrasound when they exist. Lung ultrasound (LUS) has demonstrated a sensitivity of 90% and a specificity of 98%, to detect alveolar consolidation in critical ill patients while chest radiography data are known to be imprecise.The investigator would like to explore the utility of LUS in postsurgical patients and the relationship between degree of hypoxemia and consolidation area. Objectives: 1. Primary: Forced vital capacity decreases after surgery. This reduction may be relieved in the absence of residual neuromuscular block. Objective is to assess differences after reversal with neostigmine versus sugammadex in: • Forced vital capacity (FVC) 2. Secondary objectives: To assess differences after reversal with neostigmine versus sugammadex in: - Atelectasis size determined by lung ultrasound (Plannimetry) - pO2/FiO2 <300 1 hour after surgery - Explore the accuracy of lung ultrasound (LUS) to diagnosis postoperative atelectasis and its correlation with chest Xray, FVC and pO2/FiO2. Hypotheses: 1. Sugammadex NMB reversal results in a lower reduction of forced vital capacity (FVC) as compared to NMB reversal with neostigmine. 2. Atelectasis is common after major surgery. Size of atelectasis determined by lung ultrasound planimetry is lower one hour after sugammadex reversal as compared to the neostigmine group. 3. The incidence of post-surgical hypoxemia is lower in the sugammadex group as compared to the neostigmine group (Hypoxemia defined as pO2/FiO2 less than 300 is expected in 20% of patients after major abdominal surgery). 4. Lung ultrasound has a better capacity to detect alveolar consolidation than Chest Xray after major surgery. 5. Atelectasis size determine by planimetry has a good correlation with pO2/FiO2 and decrease of FVC after surgery

NCT ID: NCT02337010 Completed - Clinical trials for Postoperative Complications

Continuous Central Venous Oxygen Saturation Assisted Intraoperative Hemodynamic Management

Start date: October 2010
Phase: N/A
Study type: Interventional

Patients who are scheduled for: elective oesophageal tumour resection, total gastrectomy, pancreas resection, major vascular, total cystectomy will be recruited.To investigate effects of central venous pressure (CVP) and central venous saturation (ScvO2) guided fluid management on intraoperative haemodynamic parameters, volume and vasopressor requirement, and postoperative organ function and postoperative inflammatory response.

NCT ID: NCT02142816 Completed - Colorectal Surgery Clinical Trials

Fluid Requirement During Surgery PVI v Doppler

PVIvDoppler
Start date: January 2013
Phase: N/A
Study type: Interventional

Targeting the amount of fluid given to measurements of the patients own fluid status during major abdominal surgery has been linked with improved speed of recovery of gut function and reduced length of hospital stay, mortality and complications. Pleth variability index (PVI) offers a noninvasive, risk and pain free alternative to more invasive forms of monitoring to direct how much fluid to give. The study aims primarily to measure and compare how much fluid is given when guided by PVI compared to the established technique; oesophageal doppler during major abdominal surgery. The study will compare 40 patients undergoing major elective abdominal surgery. Patients will receive intraoperative fluid guided by either oesophageal doppler or PVI. Secondarily, the study will examine biochemical markers, length of hospital stay and how frequently complications occur

NCT ID: NCT02104687 Completed - Clinical trials for Major Abdominal Surgery

Intraoperative Haemodynamic Optimization Comparing Flow and Pressure Parameters

Flow-press
Start date: April 2014
Phase: N/A
Study type: Interventional

The purpose of the study is to confirm the hypothesis that flow treatment algorithm based on cardiac index trending by transesophageal Dopplerometry would result in reduced complications and reduced length of hospital stay in major abdominal surgery patients, when compared to patients treated with press treatment algorithm.

NCT ID: NCT02073162 Completed - Clinical trials for Major Abdominal Surgery

REstrictive Versus LIbEral Fluid Therapy in Major Abdominal Surgery

Start date: February 2014
Phase: N/A
Study type: Interventional

Physicians differ in their approaches to surgical fluid therapy, with some preferring higher volumes and others lower volumes. Each approach has potential advantages and disadvantages. Currently, there is no compelling evidence that one approach is better than the other. This study tests whether giving a volume on the low end of the usual amount ("restrictive management") has a different rate of complications compared to a volume on the high end of the usual amount ("liberal management"). This study will compare liberal and restrictive fluid management to determine their effects on major complications after abdominal surgery. Those who take part in the study will be visited five times before and after surgery in the hospital. Once discharged from the hospital, participants will be called 4 times on the telephone. Preadmission Clinic/Preoperative Visit - Sign the consent document - Have blood drawn for standard preoperative tests (standard of care) - Have an electrocardiogram (standard of care) - Complete a questionnaire on disability (research) Day of Surgery - Have blood drawn if not already done during the first visit (standard of care) - Have an electrocardiogram if not already done during the first visit (standard of care) - Be randomly assigned to either restrictive or liberal fluid management (research) Post-op Day 1 - Have an electrocardiogram done (research) - Have blood drawn for standard tests (standard of care) - Have a wound inspection, if there is a change of dressing (standard of care) - Complete a questionnaire about your recovery (research) Post-op Day 3 - Have blood drawn for standard tests (standard of care) and c-reactive protein, which can indicate infection (for research). - Have a wound inspection, if there is a change of dressing (standard of care) - Complete a questionnaire about your recovery (research) Day of Discharge - Have a wound inspection, if there is a change of dressing (standard of care) 30-Day Follow-up Phone Call - Complete a questionnaire about your recovery (research) - Complete a questionnaire about disability (research) 3 Month, 6-Month, and 12-Month Follow-up Phone Calls - Complete a questionnaire about disability (research)

NCT ID: NCT01950845 Completed - Colorectal Surgery Clinical Trials

Automated Versus Manual Fluid Management for High Risk Abdominal Surgical Patient. A Prospective, Randomized Trial

CL vs CP
Start date: February 2014
Phase: N/A
Study type: Interventional

Dynamic parameters like pulse pressure variation have been shown to be accurate predictors of fluid responsiveness. Hemodynamic optimization based on fluid management and stroke volume optimization have been shown to improve patient outcomes, especially for moderate and high risk abdominal surgical patients. A novel closed-loop fluid administration system based on multi-parameter hemodynamic monitoring have been described recently. This prospective, randomized, surgeon and patient blinded study aims at comparing the cardiac output provided by either this closed-loop system or the anesthesiologist team in high-rish surgical patient elected for abdominal surgery at Pierre Bénite University Hospital, Hospices Civils of Lyon, France. Primary endpoint is the mean indexed cardiac output during surgery per group. We will also compare hemodynamic parameter (cardiac output, stroke volume, blood pressure heart rate…) and patient's outcomes (morbidity, mortality, transfusion rate, hospital length of stay) between groups

NCT ID: NCT01403909 Withdrawn - Clinical trials for Major Abdominal Surgery

Effect of Pneumatic Intermittent Venous Compression on Fluid Volumes Infused During Major Abdominal Surgery

Start date: November 2014
Phase: N/A
Study type: Interventional

The main objective of this study was to evaluate the effect of intermittent pneumatic venous compression on intra-operative fluid intake by comparing two groups of patients with or without intermittent pneumatic compression of the lower limbs.

NCT ID: NCT01217151 Completed - Clinical trials for Major Abdominal Surgery

Perioperative Hemodynamic Optimization Using the NICOM Device

Start date: January 2011
Phase: N/A
Study type: Interventional

In the last years, there is a growing interest in the improvement of prognosis and shortening of hospital length of stay in high-risk surgical patients. Several evidence-based protocols ("fast-track" surgery) have been developed and implemented in some hospitals for this purpose. Cardiovascular optimization through the so-called "goal-directed therapy" (GDT) is a key element in these protocols. Previous studies in the literature use invasive monitors to assess hemodynamics. The NICOM ™ is a non-invasive monitor validated in several clinical scenarios. The aim of the present randomized, international, multi-center, open-label clinical trial is to use a GDT protocol (including colloid boluses and vasoactive drug infusion) based on data obtained from the NICOM™ device (cardiac index and mean arterial pressure) to test the hypothesis that GDT is superior to standard practice in terms of reduction in the incidence of perioperative complications and length of hospital stay in high-risk major abdominal surgery patients (requiring ICU surveillance for, at least, 24 hours). As secondary objectives, time to first flatus, wound infection, anastomotic leaks and mortality will be analysed. All patients will be followed from the day of surgery up to hospital discharge (determined by a specialist surgeon not involved in the study) or death.

NCT ID: NCT01194492 Completed - Clinical trials for Major Abdominal Surgery

Albumin Kinetics in Generalized Inflammation

Start date: September 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether the kinetics of endogenous albumin is altered by the generalized inflammation caused by major abdominal surgery.

NCT ID: NCT01075646 Completed - Postoperative Pain Clinical Trials

Local Anesthesia Versus Saline Serum in Surgical Incision of Colorectal or Hepatic Surgery

CATROP-2007
Start date: March 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether a continuous infusion of local anesthesia with a catheter in the surgical wound reduces patient consumption of opiates by 30% in the 48-hour postoperative period following surgery for colorectal neoplasm and hepatic surgery versus the continuous infusion of physiological serum.