A Phase 3 interventional study of Dexmedetomidine and Ketamine in Abdominal Cancer, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-01-09.
Sponsored by Assiut University · Phase 3, Interventional, and Health services research
This study aims to compare the effects of local wound infiltration with ketamine versus dexmedetomidine when added to bupivacaine on stress response and postoperative pain in lower abdominal cancer surgery.
Patients will be randomly assigned using an online research randomizer into three groups, 30 patients in each group:
Group C:
30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision( control group).
Group K:
30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline +1 mg /kg ketamine (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision.
Group D:
30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline + 1µg/kg dexmedetomidine (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision.
67 studies on the registry are indexed under Abdominal Neoplasms; 18 are open to participants now.
This study's enrollment of 90 is above the median of 74 across 49 interventional studies indexed under Abdominal Neoplasms.
Browse Abdominal Neoplasms studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
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Exclusion Criteria:
intervention: local wound infiltration 30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline +1 mg /kg ketamine (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision.
Drug: Ketamine
intervention: local wound infiltration 30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline + 1µg/kg dexmedetomidine (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision.
Drug: Dexmedetomidine
intervention: local wound infiltration 30 patients receive local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of incision( control group).
Drug: Bupivacaine
local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline plus dexmetedomidine in two divided doses i.e. 20 ml is administered on each side of incision
Also known as: subcutaneous
local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline plus ketamine in two divided doses i.e. 20 ml is administered on each side of incision
Also known as: subcutaneous
local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline only in two divided doses i.e. 20 ml is administered on each side of incision
Also known as: subcutaneous
Total morphine consumption
Time frame: 24 hours
Plasma concentrations of prolactin, cortisol and glucose level
Time frame: 24 hours
the severity of pain was assessed using VAS score
Time frame: 24 hours
Plan to share: Undecided
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Assiut University