- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02619019
Effect of Spinal Dexamethasone During Transuretheral Prostatectomy
September 13, 2016 updated by: Seham Mohamed Moeen Ibrahim, Assiut University
Intrathecal Dexamethasone in Patients Undergoing Transuretheral Prostatectomy.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Asyut, Egypt, 71111
- Seham Mohamed Moeen Ibrahim
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dexamethasone group
Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 8 mg of dexamethasone intrathecally
|
Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 8 mg of dexamethasone intrathecally
|
Active Comparator: Pethidine group
Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 0.2 mg/kg of pethidine intrathecally
|
Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 0.2 mg/kg of pethidine intrathecally
Other Names:
|
Placebo Comparator: Control group
Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 2 ml normal saline intrathecally
|
Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 2 ml normal saline intrathecally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shivering
Time Frame: 150 min after spinal anesthesia
|
by shivering score
|
150 min after spinal anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean arterial blood pressure
Time Frame: 150 min after spinal anesthesia
|
immediately before the block and then every 15 min after the block
|
150 min after spinal anesthesia
|
Heart rate
Time Frame: 150 min after spinal anesthesia
|
immediately before the block and then every 15 min after the block
|
150 min after spinal anesthesia
|
Core temperature
Time Frame: 150 min after spinal anesthesia
|
immediately before the block and then every 15 min after the block
|
150 min after spinal anesthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
November 27, 2015
First Submitted That Met QC Criteria
November 30, 2015
First Posted (Estimate)
December 2, 2015
Study Record Updates
Last Update Posted (Estimate)
September 15, 2016
Last Update Submitted That Met QC Criteria
September 13, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Dexamethasone
- Meperidine
Other Study ID Numbers
- SM112015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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