DexmedetomidinePhase 4NCT04618965
Intrathecal Versus Intravenous Dexmeditomedine in Transurethral Resection of the Prostate
A Phase 4 study testing Intrathecal dexmedetomidine and Intravenous dexmedetomidine in people with Dexmedetomidine and Transurethral Resection of Prostate, run by Tanta University.
Trial summary
This study is to evaluate The analgesic effect of intrathecal versus intravenous dexmeditomedine in transurethral resection of the prostate Read more about this study
- Who is it for?
- Ages 59 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dexmedetomidine, Transurethral Resection of Prostate, Intravenous
- What is being tested?
- Intrathecal dexmedetomidine and Intravenous dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 26 Jun 2021
- Phase
- Phase 4
- 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 59 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male gender
- 50:70years old
- ASA:I,II
Who cannot join
- contraindications of spinal anesthesia
- Patient refusal
- Patient taking alpha agonist or antagonist
- Uncontrolled cardiac diseases
- Allergy to local anesthetic drugs
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Intrathecal Versus Intravenous Dexmeditomedine on Postoperative Analgesia in Transurethral Resection of the Prostate
This study is to evaluate The analgesic effect of intrathecal versus intravenous dexmeditomedine in transurethral resection of the prostate
Read the detailed description
This study will carried out in Tanta University hospital on75 male patients Patients will randomly classified into 3 groups Group I: will receive intrathecal hyperbaric bupivacaine 10mg in 2.5 ml and .5 ml saline with 3ml total volume Group II: will receive dexmeditomedine 5Mic diluted in.5 ml saline and hyperbaric bupivacaine 10mg in 2.5ml with 3ml total volume Group IIl: Will receive intravenous dexmeditomedine started at loading dose of 1 mic/kg diluted in 50 ml saline and administered within 10 min as loading dose , followed by maintenance at a dose of .4mic/kg/h diluted in200 ml saline till the end of surgery and hyperbaric bupivacaine 10 mg in 2.5 ml total volume
- Being tested
- control group, Intrathecal dexmedetomidine, Intravenous dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupDrug
Each patient will receive intrathecal hyperbaric bupivacaine 10 mg in 2.5 ml and 0.5 ml saline with 3 mL total volume. Continous 50 ml saline infusion for 10 min followed by 200 ml saline infusion till the end of surgery.
Intrathecal dexmedetomidineDrug
Each patient will receive dexmedetomidine 5 μg diluted in 0.5ml saline and hyperbaric Bupivacaine 10 mg in 2.5 ml with 3 mL total volume. Continous 50 ml saline infusion for 10 min followed by 200 ml saline infusion till the end of surgery.
Intravenous dexmedetomidineDrug
Each patient will receive intravenous dexmedetomidine started at a loading dose of 1 μg/kg diluted in 50 ml saline and administered within 10 min as a loading dose, followed by maintenance at a dose of 0.4 μg/kg/h diluted in 200 ml saline till the end of surgery and hyperbaric Bupivacaine 10 mg in 2.5 ml total volume.
| Study group | Role | What they receive |
|---|---|---|
| Control (Placebo) group | Placebo comparator | Each patient will receive intrathecal hyperbaric bupivacaine 10 mg in 2.5 ml and 0.5 ml saline with 3 mL total volume. Continous 50 ml saline infusion for 10 min followed by 200 ml saline infusion till the end of surgery. Receives: Drug: control group |
| Intrathecal dexmedetomidine group | Experimental | Each patient will receive dexmedetomidine 5 μg diluted in 0.5ml saline and hyperbaric Bupivacaine 10 mg in 2.5 ml with 3 mL total volume. Continous 50 ml saline infusion for 10 min followed by 200 ml saline infusion till the end of surgery. Receives: Drug: Intrathecal dexmedetomidine |
| Intravenous dexmedetomidine group | Experimental | Each patient will receive intravenous dexmedetomidine started at a loading dose of 1 μg/kg diluted in 50 ml saline and administered within 10 min as a loading dose, followed by maintenance at a dose of 0.4 μg/kg/h diluted in 200 ml saline till the end of surgery and hyperbaric Bupivacaine 10 mg in 2.5 ml total volume. Receives: Drug: Intravenous dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to first rescue analgesic
The duration between the administration of spinal block and the first desire for supplemental analgesia (onset of 1st post-operative analgesic dose).
First post-operative analgesic dose will be1 μg/kg intravenous fentanyl when visual analogue pain score (VAS) is 4 or more
Measured: 24 hours postoperative
Secondary outcomes (3)
Postoperative pain score Total dose of analgesic consumption I the first postoperative day Intraoperative and postoperative complications
Visual analogue score (VAS) between 0 and 10{0= no pain, 10=most severe pain}
Measured: 24 hours postoperative
Total analgesic consumption
The pain score will be assessed every 4 h in 24 h and fentanyl will be given in a dose of 1 μg /kg when Visual analogue score (VAS) is 4 or more. Any out breaking pain will be treated with increments of fentanyl in a dose of 0.5μg/kg.
Measured: 24 hours postoperative
Intraoperative and postoperative complications
e.g. hypotension, bradycardia and vomiting
Measured: Intraoperative and 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Nov 2020 (estimated)
- Primary completion26 Apr 2021 (estimated)
- Study completion26 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Tanta 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laila Elahwal, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618965
- Sponsor's protocol ID
- Pain relief for prostatictomy
- Status last verified
- Nov 2020
- First submitted
- 26 Oct 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intrathecal Versus Intravenous Dexmeditomedine on Postoperative Analgesia in Transurethral Resection of the Prostate
- ClinicalTrials.gov ID
- NCT04618965
- Acronym / sponsor ID
- Pain relief for prostatictomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 26 Apr 2021 (estimated)
- Study completion
- 26 Jun 2021 (estimated)
- First posted
- 6 Nov 2020 (actual)
- 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.
This study is to evaluate The analgesic effect of intrathecal versus intravenous dexmeditomedine in transurethral resection of the prostate
Detailed description
This study will carried out in Tanta University hospital on75 male patients Patients will randomly classified into 3 groups Group I: will receive intrathecal hyperbaric bupivacaine 10mg in 2.5 ml and .5 ml saline with 3ml total volume Group II: will receive dexmeditomedine 5Mic diluted in.5 ml saline and hyperbaric bupivacaine 10mg in 2.5ml with 3ml total volume Group IIl: Will receive intravenous dexmeditomedine started at loading dose of 1 mic/kg diluted in 50 ml saline and administered within 10 min as loading dose , followed by maintenance at a dose of .4mic/kg/h diluted in200 ml saline till the end of surgery and hyperbaric bupivacaine 10 mg in 2.5 ml total volume
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control (Placebo) group | Placebo comparator | Drug: control groupEach patient will receive intrathecal hyperbaric bupivacaine 10 mg in 2.5 ml and 0.5 ml saline with 3 mL total volume. Continous 50 ml saline infusion for 10 min followed by 200 ml saline infusion till the end of surgery. |
| Intrathecal dexmedetomidine group | Experimental | Drug: Intrathecal dexmedetomidineEach patient will receive dexmedetomidine 5 μg diluted in 0.5ml saline and hyperbaric Bupivacaine 10 mg in 2.5 ml with 3 mL total volume. Continous 50 ml saline infusion for 10 min followed by 200 ml saline infusion till the end of surgery. |
| Intravenous dexmedetomidine group | Experimental | Drug: Intravenous dexmedetomidineEach patient will receive intravenous dexmedetomidine started at a loading dose of 1 μg/kg diluted in 50 ml saline and administered within 10 min as a loading dose, followed by maintenance at a dose of 0.4 μg/kg/h diluted in 200 ml saline till the end of surgery and hyperbaric Bupivacaine 10 mg in 2.5 ml total volume. |
Who may qualify
- Ages
- 59 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male gender
- 50:70years old
- ASA:I,II
Key exclusion criteria (5 listed)
- contraindications of spinal anesthesia
- Patient refusal
- Patient taking alpha agonist or antagonist
- Uncontrolled cardiac diseases
- Allergy to local anesthetic drugs
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 |
|---|---|---|
| control groupEach patient will receive intrathecal hyperbaric bupivacaine 10 mg in 2.5 ml and 0.5 ml saline with 3 mL total volume. Continous 50 ml saline infusion for 10 min followed by 200 ml saline infusion till the end of surgery. | Drug | Control (Placebo) group |
| Intrathecal dexmedetomidineEach patient will receive dexmedetomidine 5 μg diluted in 0.5ml saline and hyperbaric Bupivacaine 10 mg in 2.5 ml with 3 mL total volume. Continous 50 ml saline infusion for 10 min followed by 200 ml saline infusion till the end of surgery. | Drug | Intrathecal dexmedetomidine group |
| Intravenous dexmedetomidineEach patient will receive intravenous dexmedetomidine started at a loading dose of 1 μg/kg diluted in 50 ml saline and administered within 10 min as a loading dose, followed by maintenance at a dose of 0.4 μg/kg/h diluted in 200 ml saline till the end of surgery and hyperbaric Bupivacaine 10 mg in 2.5 ml total volume. | Drug | Intravenous dexmedetomidine group |
Primary outcome
The time to first rescue analgesic
Time frame: 24 hours postoperative
The duration between the administration of spinal block and the first desire for supplemental analgesia (onset of 1st post-operative analgesic dose). First post-operative analgesic dose will be1 μg/kg intravenous fentanyl when visual analogue pain score (VAS) is 4 or more
3 secondary outcomes
Postoperative pain score Total dose of analgesic consumption I the first postoperative day Intraoperative and postoperative complications
Time frame: 24 hours postoperative
Total analgesic consumption
Time frame: 24 hours postoperative
Intraoperative and postoperative complications
Time frame: Intraoperative and 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intrathecal dexmedetomidine and Intravenous dexmedetomidine in people with Dexmedetomidine and Transurethral Resection of Prostate, run by Tanta University.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laila ElAhwal, MD (00201018484319, lailaalahwal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to first rescue analgesic (time frame: 24 hours postoperative). 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 6 Nov 2020.