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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05262166
Other study ID # MS.21.10.1699(date 21/11/2021)
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 10, 2022
Est. completion date August 15, 2022

Study information

Verified date March 2022
Source Mansoura University
Contact MOHAMED A GHANEM
Phone 01067883998
Email MOHAMED.ABDEL_LATIF@YAHOO.COM
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

this study is designed to compare intrathecal bolus of bupivacaine-dexmedetomidine versus continuous epidural fentanyl infusion in providing effective operative analgesia, intraoperative hemodynamic stability and less postoperative cumulative opioid induced complications in orthotopic urinary bladder diversion prolonged surgery. The hypothesis Intrathecal bolus of bupivacaine-dexmedetomidine could replace continuous epidural fentanyl infusion and would be an enough intraoperative analgesic modality with good intraoperative hemodynamic stability and less postoperative complications in orthotopic urinary bladder diversion patients. Aim of the work The aim of this protocol is to document that intrathecal bolus of bupivacaine-dexmedetomidine analgesia (a low coast analgesic modality) can replace continuous epidural fentanyl infusion analgesic modality with effective operative analgesia, intraoperative hemodynamic stability and less postoperative cumulative opioid induced complications in orthotopic urinary bladder diversion prolonged surgery.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
INTRATHECAL dexmedetomidine INJECTION
intrathecal bolus of 3ml bupivacaine 0.5% (15mg) plus 10 micrograms dexmedetomidine at 2-3 or 3-4 spinal level.

Locations

Country Name City State
Egypt Medicine Mansoura Dakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total postoperative ANALGESIC fentanyl DOSE Total postoperative intravenous fentanyl requirements in the first twinty four hours after spinal dexmedetomedine first 24 hours in both groups.
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