Effect of Spinal Dexamethasone During Transuretheral Prostatectomy

Phase 2

Completed

• Conditions: Postspinal Shivering
• Interventions: Drug: Normal saline; Drug: Dexamethasone; Drug: Pethidine

• Registration Number: NCT02619019
• Lead Sponsor: Assiut University

Brief Summary

Dexamethasone, a high-potency, long-acting glucocorticoid, when added to bupivacaine, it extended the duration of analgesia. We aim to study the effectiveness of spinal dexamethasone in Transuretheral prostatectomy.

Detailed Description

Spinal anesthesia for endoscopic urology surgery like transurethral resection of the prostate is a well-established technique. Opioids are extensively used as an adjunct to local anesthetics in neuraxial blockade to enhance the duration of postoperative analgesia. However, worrisome adverse effects like pruritus, urinary retention, postoperative vomiting and respiratory depression limit its use. The aim of this study was to investigate the effectiveness of Intrathecal dexamethasone as adjunct to local anesthetics.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-27
• Study First Submitted QC: 2015-11-30
• Study First Posted: 2015-12-02
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 90

Inclusion Criteria

• Age: 50-75 yr ASA class I,II, and III undergoing Transuretheral prostatectomy under spinal anesthesia

Exclusion Criteria

• Contraindications to spinal anesthesia, Allergy to the study medication, Thyroid disease, Parkinson's disease Patients receiving vasodilators or medications likely to alter thermoregulation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Normal saline	Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 2 ml normal saline intrathecally
Dexamethasone group	Dexamethasone	Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 8 mg of dexamethasone intrathecally
Pethidine group	Pethidine	Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 0.2 mg/kg of pethidine intrathecally

Primary Outcome Measures

Name	Time	Method
Shivering	150 min after spinal anesthesia	by shivering score

Secondary Outcome Measures

Name	Time	Method
Heart rate	150 min after spinal anesthesia	immediately before the block and then every 15 min after the block
Core temperature	150 min after spinal anesthesia	immediately before the block and then every 15 min after the block
Mean arterial blood pressure	150 min after spinal anesthesia	immediately before the block and then every 15 min after the block

Trial Locations

Locations (1)

Seham Mohamed Moeen Ibrahim; 🇪🇬 Asyut, Egypt