Lower Extremity Chronic Venous UlcersPhase 4NCT06612996
Intravenous Tramadol and Magnesium Sulphate for Prevention of Shivering
A Phase 4 study testing Tramadol, Magnesium sulphate and Saline in people with Lower Extremity Chronic Venous Ulcers and Varicose Veins Leg, run by Al-Azhar University.
Trial summary
The aim of this work was to compare the efficacy of intravenous (IV) tramadol versus magnesium sulphate added to 100 ml saline for prevention of shivering associated with spinal anesthesia. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Lower Extremity Chronic Venous Ulcers, Varicose Veins Leg, Hernia
- What is being tested?
- Tramadol, Magnesium sulphate and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2024to 10 Jan 2025
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) I and II physical status undergoing an elective surgery under spinal anesthesia.
Who cannot join
- history of uncontrolled comorbidities, cardiac, respiratory, renal or hepatic disease, patients who had allergy to any medication in the study, contraindications to spinal anesthesia (coagulation disorder, infection at site of puncture, raised intracranial tension or any spine deformity), fever \>38 Celsius or less than 36 Celsius, body mass index more than 35 and who has history of alcohol intake
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Between Intravenous Tramadol and Magnesium Sulphate for Prevention of Shivering Post Intrathecal Anesthesia a Randomized Clinical Study
The aim of this work was to compare the efficacy of intravenous (IV) tramadol versus magnesium sulphate added to 100 ml saline for prevention of shivering associated with spinal anesthesia.
- Being tested
- Tramadol, Magnesium sulphate, Saline
- Keywords
- Tramadol, Magnesium Sulphate, Shivering
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
Intravenous tramadol
Magnesium sulphateDrug
Intravenous magnesium sulphate
SalineOther
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| Tramadol group | Experimental | Intravenous Tramadol Receives: Drug: Tramadol |
| Magnesium sulphate group | Experimental | Intravenous Magnesium Sulphate Receives: Drug: Magnesium sulphate |
| Control group | Placebo comparator | Saline Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shivering score
Shivering score
Measured: 90 minutes postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start10 Oct 2024 (estimated)
- Primary completion10 Jan 2025 (estimated)
- Study completion10 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity Chronic Venous UlcersStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Warda Demerdash Khalifa Ali, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612996
- Sponsor's protocol ID
- AZAST/19/14-May-2024
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- 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 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Intravenous Tramadol and Magnesium Sulphate for Prevention of Shivering Post Intrathecal Anesthesia a Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06612996
- Acronym / sponsor ID
- AZAST/19/14-May-2024
- Keywords
- Tramadol, Magnesium Sulphate, Shivering
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (estimated)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 25 Sep 2024 (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.
The aim of this work was to compare the efficacy of intravenous (IV) tramadol versus magnesium sulphate added to 100 ml saline for prevention of shivering associated with spinal anesthesia.
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 |
|---|---|---|
| Tramadol group | Experimental | Drug: TramadolIntravenous Tramadol |
| Magnesium sulphate group | Experimental | Drug: Magnesium sulphateIntravenous Magnesium Sulphate |
| Control group | Placebo comparator | Other: SalineSaline |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) I and II physical status undergoing an elective surgery under spinal anesthesia.
Key exclusion criteria (1 listed)
- history of uncontrolled comorbidities, cardiac, respiratory, renal or hepatic disease, patients who had allergy to any medication in the study, contraindications to spinal anesthesia (coagulation disorder, infection at site of puncture, raised intracranial tension or any spine deformity), fever \>38 Celsius or less than 36 Celsius, body mass index more than 35 and who has history of alcohol intake
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 |
|---|---|---|
| TramadolIntravenous tramadol | Drug | Tramadol group |
| Magnesium sulphateIntravenous magnesium sulphate | Drug | Magnesium sulphate group |
| SalineNormal saline | Other | Control group |
Primary outcome
Shivering score
Time frame: 90 minutes postoperatively
Shivering score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- 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 Tramadol, Magnesium sulphate and Saline in people with Lower Extremity Chronic Venous Ulcers and Varicose Veins Leg, run by Al-Azhar 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 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: status not confirmed, as of the sponsor's last update on 25 Sep 2024. 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 Warda Demerdash Ali, PhD (088 2148087, warda2001@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shivering score (time frame: 90 minutes postoperatively). 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 25 Sep 2024.