CURES: The Effect of Deep Curarisation and Reversal With Sugammadex on Surgical Conditions and Pe… (NCT01748643) | Clinical Trial Compass
CompletedPhase 4
CURES: The Effect of Deep Curarisation and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity
Belgium60 participantsStarted 2013-04
Plain-language summary
The purpose of this study is to investigate if a deep neuromuscular block with a continuous infusion of rocuronium titrated to a post-tetanic count (PTC) of 1-2 responses combined with reversal of neuromuscular blockade with sugammadex results in improved surgical conditions for the surgeon and/or improved post-operative respiratory function for the patients as compared to a standard technique with an intubation dose of rocuronium and top-ups as needed to maintain a neuromuscular blockade with a train of four (TOF) count of 1-2 and reversal of neuromuscular blockade with neostigmine/glycopyrrolate.
Furthermore, we want to investigate the effect of pneumoperitoneum, and NMB with rocuronium and reversal with sugammadex or neostigmine/glycopyrrolate on cerebral tissue oxygenation.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Able to give written informed consent
✓. American Society of Anaesthesiologists class I, II or III
✓. Obese or morbid obese as defined by BMI \> 30 and \>40 kg/m2 respectively
Exclusion criteria
✕. Neuromuscular disorders
✕. Allergies to, or contraindication for muscle relaxants, neuromuscular reversing agents, anaesthetics, narcotics
✕. Malignant hyperthermia
✕. Pregnancy or lactation
✕. Renal insufficiency defined as serum creatinine of 2x the upper normal limit, glomerular filtration rate \< 60ml/min, urine output of \< 0.5ml/kg/h for at least 6h
✕. Chronic obstructive pulmonary disease GOLD classification 2 or higher.
✕. Clinical, radiographic or laboratory findings suggesting upper or lower airway infection
What they're measuring
1
Subjective Evaluation of the View on the Operating Field by the Surgeon
Timeframe: Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h
2
Number of Intra-abdominal Pressure Rises > 18cmH2O
Timeframe: Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h
3
Duration of Surgery
Timeframe: Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h