Dexmedetomidine, Transurethral Resection of Prostate, Intravenous, Intrathecal
Conditions
Brief summary
This study is to evaluate The analgesic effect of intrathecal versus intravenous dexmeditomedine in transurethral resection of the prostate
Detailed description
This study will carried out in Tanta University hospital on75 male patients Patients will randomly classified into 3 groups Group I: will receive intrathecal hyperbaric bupivacaine 10mg in 2.5 ml and .5 ml saline with 3ml total volume Group II: will receive dexmeditomedine 5Mic diluted in.5 ml saline and hyperbaric bupivacaine 10mg in 2.5ml with 3ml total volume Group IIl: Will receive intravenous dexmeditomedine started at loading dose of 1 mic/kg diluted in 50 ml saline and administered within 10 min as loading dose , followed by maintenance at a dose of .4mic/kg/h diluted in200 ml saline till the end of surgery and hyperbaric bupivacaine 10 mg in 2.5 ml total volume
Interventions
DRUGcontrol group
Each patient will receive intrathecal hyperbaric bupivacaine 10 mg in 2.5 ml and 0.5 ml saline with 3 mL total volume. Continous 50 ml saline infusion for 10 min followed by 200 ml saline infusion till the end of surgery.
Each patient will receive dexmedetomidine 5 μg diluted in 0.5ml saline and hyperbaric Bupivacaine 10 mg in 2.5 ml with 3 mL total volume. Continous 50 ml saline infusion for 10 min followed by 200 ml saline infusion till the end of surgery.
Each patient will receive intravenous dexmedetomidine started at a loading dose of 1 μg/kg diluted in 50 ml saline and administered within 10 min as a loading dose, followed by maintenance at a dose of 0.4 μg/kg/h diluted in 200 ml saline till the end of surgery and hyperbaric Bupivacaine 10 mg in 2.5 ml total volume.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
59 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* male gender * 50:70years old * ASA:I,II
Exclusion criteria
* contraindications of spinal anesthesia * Patient refusal * Patient taking alpha agonist or antagonist * Uncontrolled cardiac diseases * Allergy to local anesthetic drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The time to first rescue analgesic | 24 hours postoperative | The duration between the administration of spinal block and the first desire for supplemental analgesia (onset of 1st post-operative analgesic dose). First post-operative analgesic dose will be1 μg/kg intravenous fentanyl when visual analogue pain score (VAS) is 4 or more |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total analgesic consumption | 24 hours postoperative | The pain score will be assessed every 4 h in 24 h and fentanyl will be given in a dose of 1 μg /kg when Visual analogue score (VAS) is 4 or more. Any out breaking pain will be treated with increments of fentanyl in a dose of 0.5μg/kg. |
| Intraoperative and postoperative complications | Intraoperative and 24 hours postoperative | e.g. hypotension, bradycardia and vomiting |
| Postoperative pain score Total dose of analgesic consumption I the first postoperative day Intraoperative and postoperative complications | 24 hours postoperative | Visual analogue score (VAS) between 0 and 10{0= no pain, 10=most severe pain} |
Contacts
Primary ContactLaila ElAhwal, MD
Outcome results
None listed