Obesity Clinical Trial
— CURESOfficial title:
Effect of Deep Curarisation and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity in Patients Undergoing Laparoscopic Gastric Bypass Surgery
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 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/glycopyrolate on cerebral tissue oxygenation.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 2015 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Able to give written informed consent 2. American Society of Anaesthesiologists class I, II or III 3. Obese or morbid obese as defined by BMI > 30 and >40 kg/m2 respectively Exclusion Criteria: 1. Neuromuscular disorders 2. Allergies to, or contraindication for muscle relaxants, neuromuscular reversing agents, anaesthetics, narcotics 3. Malignant hyperthermia 4. Pregnancy or lactation 5. 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 6. Chronic obstructive pulmonary disease GOLD classification 2 or higher. 7. Clinical, radiographic or laboratory findings suggesting upper or lower airway infection 8. Congestive heart failure. 9. Pickwick syndrome 10. Psychiatric illness inhibiting cooperation with study protocol or possibly obscuring results |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Belgium | Ziekenhuis Oost-Limburg | Genk | Limburg |
Lead Sponsor | Collaborator |
---|---|
Ziekenhuis Oost-Limburg | Merck Sharp & Dohme Corp. |
Belgium,
Ali HH, Wilson RS, Savarese JJ, Kitz RJ. The effect of tubocurarine on indirectly elicited train-of-four muscle response and respiratory measurements in humans. Br J Anaesth. 1975 May;47(5):570-4. — View Citation
Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Residual neuromuscular block is a risk factor for postoperative pulmonary complications. A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand. 1997 Oct;41(9):1095-1103. — View Citation
Cohen LB, Delegge MH, Aisenberg J, Brill JV, Inadomi JM, Kochman ML, Piorkowski JD Jr; AGA Institute. AGA Institute review of endoscopic sedation. Gastroenterology. 2007 Aug;133(2):675-701. Review. — View Citation
Eikermann M, Groeben H, Hüsing J, Peters J. Accelerometry of adductor pollicis muscle predicts recovery of respiratory function from neuromuscular blockade. Anesthesiology. 2003 Jun;98(6):1333-7. — View Citation
Eikermann M, Zaremba S, Malhotra A, Jordan AS, Rosow C, Chamberlin NL. Neostigmine but not sugammadex impairs upper airway dilator muscle activity and breathing. Br J Anaesth. 2008 Sep;101(3):344-9. doi: 10.1093/bja/aen176. Epub 2008 Jun 16. — View Citation
Eriksson LI. Reduced hypoxic chemosensitivity in partially paralysed man. A new property of muscle relaxants? Acta Anaesthesiol Scand. 1996 May;40(5):520-3. — View Citation
Gallagher SF, Haines KL, Osterlund LG, Mullen M, Downs JB. Postoperative hypoxemia: common, undetected, and unsuspected after bariatric surgery. J Surg Res. 2010 Apr;159(2):622-6. doi: 10.1016/j.jss.2009.09.003. Epub 2009 Sep 25. — View Citation
Miller MR, Dickinson SA, Hitchings DJ. The accuracy of portable peak flow meters. Thorax. 1992 Nov;47(11):904-9. — View Citation
Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS. Residual neuromuscular blockade and critical respiratory events in the postanesthesia care unit. Anesth Analg. 2008 Jul;107(1):130-7. doi: 10.1213/ane.0b013e31816d1268. — View Citation
Payne JP, Hughes R, Al Azawi S. Neuromuscular blockade by neostigmine in anaesthetized man. Br J Anaesth. 1980 Jan;52(1):69-76. — View Citation
Pratt CI. Bronchospasm after neostigmine. Anaesthesia. 1988 Mar;43(3):248. — View Citation
Pühringer FK, Rex C, Sielenkämper AW, Claudius C, Larsen PB, Prins ME, Eikermann M, Khuenl-Brady KS. Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. Anesthesiology. 2008 Aug;109(2):188-97. doi: 10.1097/ALN.0b013e31817f5bc7. — View Citation
Saliman JA, Benditt JO, Flum DR, Oelschlager BK, Dellinger EP, Goss CH. Pulmonary function in the morbidly obese. Surg Obes Relat Dis. 2008 Sep-Oct;4(5):632-9; discussion 639. doi: 10.1016/j.soard.2008.06.010. Epub 2008 Jul 17. — View Citation
Sundman E, Witt H, Olsson R, Ekberg O, Kuylenstierna R, Eriksson LI. The incidence and mechanisms of pharyngeal and upper esophageal dysfunction in partially paralyzed humans: pharyngeal videoradiography and simultaneous manometry after atracurium. Anesthesiology. 2000 Apr;92(4):977-84. — View Citation
Wyon N, Joensen H, Yamamoto Y, Lindahl SG, Eriksson LI. Carotid body chemoreceptor function is impaired by vecuronium during hypoxia. Anesthesiology. 1998 Dec;89(6):1471-9. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Subjective evaluation of the view on the operating field by the surgeon | At the end of surgery, the view on the operating field will be graded by the surgeon using a 5-point rating scale: Extremely poor Poor Acceptable Good Optimal |
Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h | No |
Primary | Number of intra-abdominal pressure rises > 15cmH2O | The number of intra-abdominal pressure rises > 15cmH2O detected by the intra-abdominal CO2 insufflator. | Participants will be followed for the duration of the laparoscopic gastric bypass surgery, an expected average of 1.5h | No |
Secondary | Respiratory function | Respiratory function will be assessed by measuring peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1) with the Vitalograph® electronic portable peak flow meter. A mean of 3 measurements in the upright posture in bed before and after surgery will be used. | Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone)) | Yes |
Secondary | Oxygen saturation | Oxygen saturation will be measured non-invasively with a pulse oxymeter | Measured the day before surgery and 30min after completion of surgery (when the modified observer's assessment of alertness/sedation scale is 5 (Patient responds readily to name spoken in normal tone)) | Yes |
Secondary | Effect of pneumoperitoneum on cerebral tissue oxygenation. | Using near infrared spectroscopy (Fore-sight®) technology, absolute brain tissue oxygenation can be quantified non-invasively by applying 2 skin electrodes to the forehead of the patient. | Participants will be followed for an expected average of 5min after the start of intra-abdominal CO2 insufflation by the surgeon | No |
Secondary | Effect of neuromuscular blockade on cerebral tissue oxygenation | Using near infrared spectroscopy (Fore-sight®) technology, absolute brain tissue oxygenation can be quantified non-invasively by applying 2 skin electrodes to the forehead of the patient. | Participants will be followed for an expected average of 5min after the intravenous injection of rocuronium | No |
Secondary | The effect of reversal of neuromuscular blockade (with sugammadex or neostigmine) on cerebral tissue oxygenation | Using near infrared spectroscopy (Fore-sight®) technology, absolute brain tissue oxygenation can be quantified non-invasively by applying 2 skin electrodes to the forehead of the patient. | Participants will be followed for an expected average of 5min after the intravenous injection of sugammadex or neostigmine | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |