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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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16 December 2017 |
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Main ID: |
NCT02385539 |
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Date of registration:
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02/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Intrathecal Administration of Levobupivacaine and Opioids in Elderly
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Scientific title:
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Intrathecal Anesthesia for Elderly Patients Undergoing Surgery Lasting >45 Minutes: A Randomized, Controlled, Dose and Combination Finding Study |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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240 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02385539 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Croatia
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Contacts
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Name:
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Jadranka Pavicic Šaric, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Merkur |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- male patients
- ASA II-III undergoing elective urological (transuretheral or transvesical
prostatectomy, hydrocelectomy, orchiectomy) or lower abdominal (inguinal
herniorrhaphy) surgery under spinal anesthesia requiring a sensory block to at least
the tenth thoracic dermatoma, lasting >45 minutes.
Exclusion Criteria:
- severe systemic disorders
- patients unwilling to accept regional anesthesia
- patients who will develope sensory block level lower than T10 dermatoma after
intrathecal injection
- patients with an abnormal coagulation profile or with significant pulmonary disease
(reactive airway disease or chronic obstructive pulmonary disease requiring daily
bronchodilator or steroid use and/or room air oxygen saturation <95% immediately
before surgery).
Age minimum:
65 Years
Age maximum:
95 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Adverse Reaction to Spinal Anesthetic
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Intervention(s)
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Drug: The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection.
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Primary Outcome(s)
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Optimal dose and combination of Levobupivacaine and Fentanyl or Sufentanil in elderly patients
[Time Frame: 9 months]
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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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