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Effect of Spinal Dexamethasone During Transuretheral Prostatectomy

Intrathecal Dexamethasone in Patients Undergoing Transuretheral Prostatectomy.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02619019
Enrollment
90
Registered
2015-12-02
Start date
2015-11-30
Completion date
2016-06-30
Last updated
2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postspinal Shivering

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.

Interventions

DRUGDexamethasone

Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 8 mg of dexamethasone intrathecally

DRUGPethidine

Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 0.2 mg/kg of pethidine intrathecally

DRUGNormal saline

Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 2 ml normal saline intrathecally

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
50 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Shivering150 min after spinal anesthesiaby shivering score

Secondary

MeasureTime frameDescription
Mean arterial blood pressure150 min after spinal anesthesiaimmediately before the block and then every 15 min after the block
Heart rate150 min after spinal anesthesiaimmediately before the block and then every 15 min after the block
Core temperature150 min after spinal anesthesiaimmediately before the block and then every 15 min after the block

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026