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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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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12615000288527 |
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Date of registration:
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27/03/2015 |
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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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Efficacy of epidural Dexmedetomidine as analgesic adjunct to local anesthetic in patients undergoing major abdominal cancer surgery
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Scientific title:
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In major abdominal cancer surgery, does epidural dexmedetomidine added to bupivacaine, compared to epidural bupivacaine only, reduce postoperative opioid consumption? |
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Date of first enrolment:
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25/01/2015 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12615000288527.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial;
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Phase:
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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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Dr diab fuad hetta
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Address:
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10 soliman hakeem street, assuit city, 71111, egypt
organization address: south egypt cancer institute, 2 el methaque st., assuit city, 71111, egypt
Egypt |
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Telephone:
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+201091090009 |
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Email:
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diabhetta@gmail.com |
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Affiliation:
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Name:
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Dr diab fuad hetta
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Address:
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10 soliman hakeem street, assuit city, 71111, egypt
organization address: south egypt cancer institute, 2 el methaque st., assuit city, 71111, egypt
Egypt |
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Telephone:
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+201091090009 |
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Email:
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diabhetta@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: patients with physical status American Society of Anaesthesiologist (ASA) I , II and III who will undergo major abdominal cancer surgery will be enrolled into the study.
Exclusion criteria: Patients with coagulation abnormalities, spinal deformities, and patients allergic to amide type of local anesthetics or Dexmedetomidine will be excluded from the study.
Age minimum:
20 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Anaesthesiology - Anaesthetics
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Surgery - Other surgery
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Cancer - Any cancer
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Post-operative pain following major abdominal cancer surgery.;
Post-operative pain following major abdominal cancer surgery.
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Intervention(s)
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Before induction of anesthesia (pre-incision), for group BD, we will give epidural bolous dose of Dexmedetomidine 0.2 mic /kg added to 0.1 ml /kg of Bupivacaine 0.125%, then, we will give epidural infusion of Dexmedetomidine 0.2 mic /kg /h added to 0.1 ml /kg/h of Bupivacaine 0.125% for 48 h postoperatively . for group B, we will give epidural bolous dose of 0.1 ml /kg Bupivacaine 0.125%, then, we will give epidural infusion of 0.1 ml /kg/h of Bupivacaine 0.125% for 48 h postoperatively.
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Primary Outcome(s)
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postoperative opioid consumption of patients recorded by research nurse.[48 hours postoperatively]
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Secondary Outcome(s)
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pain intensity by visual analogue scale[pain intensity by visual analogue scale assessed at 2h, 4 h, 8 h, 16 h, 24 h, 36 h and 48 h postoperatively]
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Source(s) of Monetary Support
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diab fuad hetta
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Ethics review
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Status: Approved
Approval date:
Contact:
South Egypt Cancer institute-IRB IORG0006563
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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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