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Clinical Trials/NCT04618965
NCT04618965
Unknown
Phase 4

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

Tanta University0 sites75 target enrollmentNovember 1, 2020

Overview

Phase
Phase 4
Intervention
control group
Conditions
Dexmedetomidine
Sponsor
Tanta University
Enrollment
75
Primary Endpoint
The time to first rescue analgesic
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
November 1, 2020
End Date
June 26, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Laila Elahwal

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Tanta University

Eligibility Criteria

Inclusion Criteria

  • male gender
  • 50:70years old

Exclusion Criteria

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

Arms & Interventions

Control (Placebo) 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.

Intervention: control group

Intrathecal dexmedetomidine group

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.

Intervention: Intrathecal dexmedetomidine

Intravenous dexmedetomidine group

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.

Intervention: Intravenous dexmedetomidine

Outcomes

Primary Outcomes

The time to first rescue analgesic

Time Frame: 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 Outcomes

  • Intraoperative and postoperative complications(Intraoperative and 24 hours postoperative)
  • 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)

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