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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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8 February 2016 |
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Main ID: |
NCT02397603 |
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Date of registration:
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15/03/2015 |
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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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Peri-neural Dexmedetomidine as an Adjuvant to Bupivacaine Induced Paravertebral Block in Patients Undergonig Thoracotomy
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Scientific title:
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Peri-neural Dexmedetomidine as an Adjuvant to Bupivacaine-induced Paravertebral Block in Patients Undergoing Thoracotomy |
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Date of first enrolment:
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February 2015 |
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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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https://clinicaltrials.gov/show/NCT02397603 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Mohamed Abdulatif, 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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Professor of anesthesia, surgical intensive care and pain management cairo university |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- American society of anesthesiologists physical status class ||or |||.
- Patients scheduled for elective thoracotomy.
Exclusion Criteria:
- Pneumonectomy, decortication, pleural biopsy.
- Additional chest wall resection.
- Emergency surgery.
- Central and peripheral neuropathies.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Post-thoracotomy Pain
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Intervention(s)
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Drug: Bupivacaine saline
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Drug: dexmedetomidine bupivacaine
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Primary Outcome(s)
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Duration of first loading preoperative dose of paravertebral injectate
[Time Frame: One day]
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Secondary Outcome(s)
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Total intraoperative ephedrine and atropine requirements
[Time Frame: Intraoperative period, up to 3-4 hours]
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Total intraoperative fentanyl requirements
[Time Frame: Intraoperative period, up to 3-4 hours]
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Number of paravertebral to-up injections
[Time Frame: 48 hours postoperatively]
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Duration of surgery and anesthesia
[Time Frame: Intraoperative period, up to 3-4 hours]
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Recovery time
[Time Frame: Immediate postoperative period, up to 2 hour]
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End tidal isoflurane
[Time Frame: Duration of anesthesia, up to 3-4 hours]
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Total doses of bupivacaine, dexmedetomidine, and morphine
[Time Frame: 48 hours postoperatively]
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Total intraoperative crystalloid requirements
[Time Frame: Intraoperative period, up to 3-4 hours]
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Pain intensities at rest and during coughing as assessed by 0-10 VAS score
[Time Frame: Over 48 hours postoperatively]
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Side effects
[Time Frame: 48 hours postoperatively]
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Secondary ID(s)
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N-16-2015
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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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