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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01631396 |
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Date of registration:
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14/06/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison of Two Neuromuscular Anesthetics Reversal in Obese Patient Undergoing Bariatric Surgery
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Scientific title:
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Comparison of Two Neuromuscular Anesthetics Reversal in Obese Patient Undergoing Bariatric Surgery |
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Date of first enrolment:
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July 2012 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01631396 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case Control, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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Asnat Raziel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical Director, ICBS-Israeli Center for Bariatric Surgery |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Morbidly obese male or female patients in the age 20-65 that are candidates for
bariatric surgery.
2. Patients that can read and understand the fundamental nature of the clinical
protocol.
3. Patients must sign the Informed Consent Form.
Exclusion Criteria:
1. Patients treated with drugs that might interact with Rocuronium.
2. Patients with history of malignant hyperthermia.
3. Patients with significant renal disease.
4. Patients with a known allergy to one of the drugs used during anesthesia.
5. Patients with known muscular disease.
6. Patients with severe cardiovascular disease (NYHA>2)
7. Breast feeding patients
8. Patients refusing to follow the clinical protocol.
9. Patients participating in a different clinical trial.
10. Patients refusing to sign the Informed Consent Form
11. Physician's objection.
Age minimum:
20 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anesthesia
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Surgery
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Intervention(s)
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Drug: Sugammadex vs. Neostigmine
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Primary Outcome(s)
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Safety of Sugammadex reversal - number of drug-related adverse events with Sugammadex <= that of Neostigmine.
[Time Frame: Monitoring nueromuscular reaction from end of anesthesia recovery (in the OR) intil patient is released from hospital (48-72 h post surgery)]
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Secondary Outcome(s)
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Use of Sugammadex for neuromuscular anaesthesia reversal higher patient satisfaction compared to Neostigmine.
[Time Frame: Monitoring nueromuscular reaction from end of anesthesia recovery (in the OR) intil patient is released from hospital (48-72 h post surgery)]
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Secondary ID(s)
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AR-002-12
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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