Intrathecal Versus Intravenous Dexmeditomedine in Transurethral Resection of the Prostate

Dexmedetomidine Clinical Trial

Official title:

The Effect of Intrathecal Versus Intravenous Dexmeditomedine on Postoperative Analgesia in Transurethral Resection of the Prostate

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04618965
• Other study ID #: Pain relief for prostatictomy
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 1, 2020
• Est. completion date: June 26, 2021

Study information

• Verified date: November 2020
• Source: Tanta University
• Contact: Laila ElAhwal, MD
• Phone: 00201018484319
• Email: lailaalahwal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate The analgesic effect of intrathecal versus intravenous dexmeditomedine in transurethral resection of the prostate

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: June 26, 2021
• Est. primary completion date: April 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 59 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dexmedetomidine
• Intrathecal
• Intravenous
• Transurethral Resection of Prostate

Intervention

Drug:
• control 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.
• Intrathecal dexmedetomidine
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.
• Intravenous dexmedetomidine
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time to first rescue analgesic	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	24 hours postoperative
Secondary	Postoperative pain score Total dose of analgesic consumption I the first postoperative day Intraoperative and postoperative complications	Visual analogue score (VAS) between 0 and 10{0= no pain, 10=most severe pain}	24 hours postoperative
Secondary	Total analgesic consumption	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.	24 hours postoperative
Secondary	Intraoperative and postoperative complications	e.g. hypotension, bradycardia and vomiting	Intraoperative and 24 hours postoperative