CLINICAL TRIALS PROFILE FOR SUGAMMADEX SODIUM
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All Clinical Trials for Sugammadex Sodium
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02327494 ↗ | Study to Evaluate Oxygen Monitoring at Different Stages of Neuromuscular Blockade in Colorectal Surgery | Unknown status | Hospital Universitari de Bellvitge | 2015-01-01 | Anesthesia favouring deep/intense neuromuscular blockade during laparoscopy may restore hemodynamics. However, no studies has been performed comparing oxygenation parameters during laparoscopy in colorectal surgery in either moderate or intense neuromuscular blockade. The investigators aim to investigate whether the intense neuromuscular blockade produces a better oxygenation profile measured by the central venous oxygen saturation than the moderate neuromuscular blockade. This is a one centre, prospective clinical trial to compare oxygenation data at different stages of neuromuscular blockade in high-risk patients scheduled for colorectal surgery. Data recording will be blinded to the anesthesiologist in charge of the patient, who will manage patients by a determined protocol, based on stroke volume data to direct fluidotherapy. Data analyzer will be not be involved in the study design or in writing reports from the study. Inclusion criteria: Be a candidate to a colorectal surgical resection procedure and one of these conditions: ≥ 70 y.o, or respiratory co-morbidity, or cardiac co-morbidity or haemoglobin level < 11g/dl. The primary outcome is the absolute number of the central venous oxygen saturation, measured at the following points: basal, after tracheal intubation, before pneumoperitoneum or abdominal incision, after pneumoperitoneum or abdominal incision, 5 and 10 minutes before administration of rocuronio to produce intense blockade, continuously during profound neuromuscular blockade until the end of surgery, before sugammadex administration, after sugammadex administration, after tracheal extubation, for the 24 hours post surgical. Data of the regional cerebral oxygen saturation will be measured at the same points. The investigators hypothesize that oxygenation data will be favourable by applying the intense neuromuscular blockade in comparison with moderate neuromuscular blockade. Also, the investigators hypothesize that oxygenation data obtained during the whole procedure including the first 24-hours post-surgery, measured by the regional cerebral oxygen saturation are comparable to data obtained by the central venous oxygen saturation. The investigators want to obtain information about influence in the outcome of producing profound neuromuscular blockade during laparoscopy colorectal by comparison of outcome data with matched historical control. | |
| NCT03137290 ↗ | Comparing Reversal With Neostigmine and Sugammadex in Paediatric | Completed | Universiti Sains Malaysia | N/A | 2014-12-01 | A reversal agent is commonly given to improve neuromuscular function after intra-operative administration of non-depolarizing neuromuscular blocking agents. The administration of conventional reversal agent neostigmine is associated with many undesirable side effects. For almost a decade, a new novel drug sugammadex has been used to specifically antagonize the effect of aminosteroidal neuromuscular blocking agents. A total of 80 paediatric patients planned for general anaesthesia were divided into two groups and were given either neostigmine+atropine, or sugammadex for reversal once the operation had completed. |
| NCT03137290 ↗ | Comparing Reversal With Neostigmine and Sugammadex in Paediatric | Completed | University of Science Malaysia | N/A | 2014-12-01 | A reversal agent is commonly given to improve neuromuscular function after intra-operative administration of non-depolarizing neuromuscular blocking agents. The administration of conventional reversal agent neostigmine is associated with many undesirable side effects. For almost a decade, a new novel drug sugammadex has been used to specifically antagonize the effect of aminosteroidal neuromuscular blocking agents. A total of 80 paediatric patients planned for general anaesthesia were divided into two groups and were given either neostigmine+atropine, or sugammadex for reversal once the operation had completed. |
| NCT03196791 ↗ | Compare the Oncological Benefit of Deep Neuromuscular Block in Gastric Cancer Obesity Patient | Completed | Korea University Anam Hospital | Phase 3 | 2017-10-10 | This study is designed to evaluate the impact of muscle relaxation during laparoscopic gastrectomy on oncological benefit, especially with obese patients over BMI 25. The primary endpoint is number of harvested lymph node that is critical point regarding quality of surgery in gastric cancer treatment. The secondary endpoint is intraoperative bleeding, surgeons' satisfaction. The patients were randomly assigned to two groups using a computer-generated randomization table : 196 persons - Deep neuromuscular block group (98persons) - Moderate neuromuscular group (98persons) |
| NCT03634956 ↗ | Effect of IONM on Efficacy and Safety Using Sugammadex in Thyroid Surgery | Unknown status | Lütfiye Nuri Burat Government Hospital | N/A | 2018-08-14 | Thyroidectomy is a frequently performed surgeon by the head and neck and endocrine surgeons. In recent years, surgical techniques and technological developments have resulted in a significant reduction in complication rates. Despite these advances, there is still a great deal of anxiety about the sound problems that can be experienced in patients after surgery. In the past years,the investigators have tried to prevent recurrent nerve paralysis by using intraoperative nerve monitoring (IONM). The use of IONM has begun to be preferred by many surgeons in the investigator's country. However, the use of IONM decreases the number of recurrent nerve paralysis are still being discussed and many studies have been done. In this study, it is aimed to prevent the formation of recurrent nerve paralysis in order to safely carry out the IONM by removing the effects of neuromuscular blockade drugs using sugammadex sodium medicine in the thyroidectomy operations. |
| NCT03679611 ↗ | Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery and Complications | Recruiting | Merck Canada Inc. | Phase 4 | 2019-01-14 | Sugammadex or neostigmine are given at the end of the surgery to reverse neuro muscular blocking drugs. This study will evaluate whether reversal of NMBD with sugammadex is associated with faster recovery than neostigmine resulting in faster discharge from the operating room (OR) in obese patients with OSA undergoing bariatric surgery. Half of the patients in the study will receive sugammadex and the other half of the patients will receive neostigmine. |
| NCT03679611 ↗ | Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery and Complications | Recruiting | University Health Network, Toronto | Phase 4 | 2019-01-14 | Sugammadex or neostigmine are given at the end of the surgery to reverse neuro muscular blocking drugs. This study will evaluate whether reversal of NMBD with sugammadex is associated with faster recovery than neostigmine resulting in faster discharge from the operating room (OR) in obese patients with OSA undergoing bariatric surgery. Half of the patients in the study will receive sugammadex and the other half of the patients will receive neostigmine. |
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