Intrathecal Versus Intravenous Dexmeditomedine in Transurethral Resection of the Prostate

NCT04618965 | Unknown Phase 4

• 1 other identifier: Pain relief for prostatictomy
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Dexmedetomidine; Transurethral Resection of Prostate; Intravenous; Intrathecal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postoperative pain score Total dose of analgesic consumption I the first postoperative day Intraoperative and postoperative complications

  24 hours postoperative

• Total analgesic consumption

  24 hours postoperative

• Intraoperative and postoperative complications

  Intraoperative and 24 hours postoperative

Study Arms (3)

Control (Placebo) group

PLACEBO COMPARATOR

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.

Drug: control group

Intrathecal dexmedetomidine group

EXPERIMENTAL

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.

Drug: Intrathecal dexmedetomidine

Intravenous dexmedetomidine group

EXPERIMENTAL

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.

Drug: Intravenous dexmedetomidine

Interventions

control group DRUG

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.

Control (Placebo) group

Intrathecal dexmedetomidine DRUG

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.

Intrathecal dexmedetomidine group

Intravenous dexmedetomidine DRUG

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.

Intravenous dexmedetomidine group

Eligibility Criteria

• Age: 59 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male gender
• :70years old
• ASA:I,II

You may not qualify if:

• contraindications of spinal anesthesia
• Patient refusal
• Patient taking alpha agonist or antagonist
• Uncontrolled cardiac diseases
• Allergy to local anesthetic drugs

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Laila ElAhwal, MD

CONTACT

00201018484319; lailaalahwal@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 6, 2020
• Study Start: November 1, 2020
• Primary Completion: April 26, 2021
• Study Completion: June 26, 2021
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share