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Effect of Spinal Dexamethasone During Transuretheral Prostatectomy

A

Assiut University

Status and phase

Completed
Phase 2

Conditions

Postspinal Shivering

Treatments

Drug: Normal saline
Drug: Dexamethasone
Drug: Pethidine

Study type

Interventional

Funder types

Other

Identifiers

NCT02619019
SM112015

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

Male

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

90 participants in 3 patient groups, including a placebo group

Dexamethasone group
Active Comparator group
Description:
Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 8 mg of dexamethasone intrathecally
Treatment:
Drug: Dexamethasone
Pethidine group
Active Comparator group
Description:
Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 0.2 mg/kg of pethidine intrathecally
Treatment:
Drug: Pethidine
Control group
Placebo Comparator group
Description:
Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 2 ml normal saline intrathecally
Treatment:
Drug: Normal saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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