Postspinal ShiveringPhase 2NCT02619019
Effect of Spinal Dexamethasone During Transuretheral Prostatectomy
A Phase 2 study testing Dexamethasone, Pethidine and Normal saline in people with Postspinal Shivering, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Postspinal Shivering
- What is being tested?
- Dexamethasone, Pethidine and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2015to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 50-75 yr ASA class I,II, and III undergoing Transuretheral prostatectomy under spinal anesthesia
Who cannot join
- Contraindications to spinal anesthesia, Allergy to the study medication, Thyroid disease, Parkinson's disease Patients receiving vasodilators or medications likely to alter thermoregulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postspinal Shivering
- Being tested
- Dexamethasone, Pethidine, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 8 mg of dexamethasone intrathecally
PethidineDrug
Also called Mepredine
Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 0.2 mg/kg of pethidine intrathecally
Normal salineDrug
Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 2 ml normal saline intrathecally
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone group | Active comparator | Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 8 mg of dexamethasone intrathecally Receives: Drug: Dexamethasone |
| Pethidine group | Active comparator | Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 0.2 mg/kg of pethidine intrathecally Receives: Drug: Pethidine |
| Control group | Placebo comparator | Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 2 ml normal saline intrathecally Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shivering
by shivering score
Measured: 150 min after spinal anesthesia
Secondary outcomes (3)
Mean arterial blood pressure
immediately before the block and then every 15 min after the block
Measured: 150 min after spinal anesthesia
Heart rate
immediately before the block and then every 15 min after the block
Measured: 150 min after spinal anesthesia
Core temperature
immediately before the block and then every 15 min after the block
Measured: 150 min after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postspinal ShiveringStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham Mohamed Moeen Ibrahim, Assiut University
- Investigators
- Seham M Moeen, MD, Principal investigator, Assiut Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619019
- Sponsor's protocol ID
- SM112015
- Status last verified
- Sep 2016
- First submitted
- 27 Nov 2015
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Dexamethasone in Patients Undergoing Transuretheral Prostatectomy.
- ClinicalTrials.gov ID
- NCT02619019
- Acronym / sponsor ID
- SM112015
- Conditions
- Postspinal Shivering
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone group | Active comparator | Drug: DexamethasonePatients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 8 mg of dexamethasone intrathecally |
| Pethidine group | Active comparator | Drug: PethidinePatients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 0.2 mg/kg of pethidine intrathecally |
| Control group | Placebo comparator | Drug: Normal salinePatients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 2 ml normal saline intrathecally |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age: 50-75 yr ASA class I,II, and III undergoing Transuretheral prostatectomy under spinal anesthesia
Key exclusion criteria (1 listed)
- Contraindications to spinal anesthesia, Allergy to the study medication, Thyroid disease, Parkinson's disease Patients receiving vasodilators or medications likely to alter thermoregulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasonePatients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 8 mg of dexamethasone intrathecally | Drug | Dexamethasone group |
| PethidineAlso: MepredinePatients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 0.2 mg/kg of pethidine intrathecally | Drug | Pethidine group |
| Normal salinePatients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 2 ml normal saline intrathecally | Drug | Control group |
Primary outcome
Shivering
Time frame: 150 min after spinal anesthesia
by shivering score
3 secondary outcomes
Mean arterial blood pressure
Time frame: 150 min after spinal anesthesia
Heart rate
Time frame: 150 min after spinal anesthesia
Core temperature
Time frame: 150 min after spinal anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seham M Moeen, MD principal investigator
Assiut Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone, Pethidine and Normal saline in people with Postspinal Shivering, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shivering (time frame: 150 min after spinal anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.