Post-Surgical ComplicationPhase 3NCT05311722
Comparsion of IV Dexmedetomidine, Tramdol and Ketamine for Post Spinal Anesthesia Shivering.
A Phase 3 study testing Dexmedetomidine, Ketamine and Tramadol in people with Post-Surgical Complication, run by Sheikh Zayed Medical College.
Trial summary
To study control of post spinal shivering in patients undergoing lower segment cesarean section using dexmedetomidine, tramadol and ketamine Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-Surgical Complication
- What is being tested?
- Dexmedetomidine, Ketamine and Tramadol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2022to 20 Feb 2023
- Phase
- Phase 3
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Woman of age 18-60
- Pregnant woman in outdoor patient department and emergency
Who cannot join
- patient. with history of hypersensitivity to opioids,
- ketamine or bupivacaine
- History of cardiovascular disease,
- Hypertension,
- psychosis,
- antepartum hemorrhage,
- cord prolapse,
- fetal distress
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparing the Efficacy of Intravenous Dexmedetomidine, Tramadol and Ketamine for Control of Post Spinal Shivering in Obstetric Patients Undergoing Lower Segment C-section
To study control of post spinal shivering in patients undergoing lower segment cesarean section using dexmedetomidine, tramadol and ketamine
Read the detailed description
Its a Comparison of drugs for a better control of post spinal shivering in patietns underwent cesarean section.using grades of shivering (0-4)patients will be assessed
- Conditions
- Post-Surgical Complication
- Being tested
- Dexmedetomidine, Ketamine, Tramadol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Inj dexmedetomidine, will be given in infusion over 10 mins and their effect on post spinal shivering will be assessed.
KetamineDrug
Ketamine
TramadolDrug
Tramadol
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Inj.dexmedetomidine 0.5mcg/kg diluted in 10ml N/s given as iv infusion over 10 minutes Receives: Drug: Dexmedetomidine |
| Ketamine | Experimental | Inj.ketamine 0.5mg/kg diluted in 10ml N/s given as iv infusion over 10 minutes Receives: Drug: Ketamine |
| Tramadol | Experimental | Inj.tramadol 0.5mg/kg diluted in 10ml N/s given as iv infusion over 10 minutes Receives: Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of post spinal shivering by observing grades of shivering
Control of post spinal shivering dexmedetomidine, tramadol and ketamine for control of post spinal shivering.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start30 Apr 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion20 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Surgical ComplicationStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 drugs were given to patients
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Obaid ur Rehman, Sheikh Zayed Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311722
- Sponsor's protocol ID
- ORehman
- Status last verified
- Mar 2022
- First submitted
- 9 Mar 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Intravenous Dexmedetomidine, Tramadol and Ketamine for Control of Post Spinal Shivering in Obstetric Patients Undergoing Lower Segment C-section
- ClinicalTrials.gov ID
- NCT05311722
- Acronym / sponsor ID
- ORehman
- Conditions
- Post-Surgical Complication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Sheikh Zayed Medical CollegeOther government
- Study start
- 30 Apr 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 20 Feb 2023 (estimated)
- First posted
- 5 Apr 2022 (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.
To study control of post spinal shivering in patients undergoing lower segment cesarean section using dexmedetomidine, tramadol and ketamine
Detailed description
Its a Comparison of drugs for a better control of post spinal shivering in patietns underwent cesarean section.using grades of shivering (0-4)patients will be assessed
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 3 drugs were given to patients
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidineInj.dexmedetomidine 0.5mcg/kg diluted in 10ml N/s given as iv infusion over 10 minutes |
| Ketamine | Experimental | Drug: KetamineInj.ketamine 0.5mg/kg diluted in 10ml N/s given as iv infusion over 10 minutes |
| Tramadol | Experimental | Drug: TramadolInj.tramadol 0.5mg/kg diluted in 10ml N/s given as iv infusion over 10 minutes |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Woman of age 18-60
- Pregnant woman in outdoor patient department and emergency
Key exclusion criteria (8 listed)
- patient. with history of hypersensitivity to opioids,
- ketamine or bupivacaine
- History of cardiovascular disease,
- Hypertension,
- psychosis,
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 |
|---|---|---|
| DexmedetomidineInj dexmedetomidine, will be given in infusion over 10 mins and their effect on post spinal shivering will be assessed. | Drug | Dexmedetomidine |
| KetamineKetamine | Drug | Ketamine |
| TramadolTramadol | Drug | Tramadol |
Primary outcome
Assessment of post spinal shivering by observing grades of shivering
Time frame: 10 minutes
Control of post spinal shivering dexmedetomidine, tramadol and ketamine for control of post spinal shivering.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Post-Surgical Complication
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
RecruitingPhase 2
Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot Study
Chronic Postsurgical Pain, Chronic Post Cancer Surgery Pain
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 3 study testing Dexmedetomidine, Ketamine and Tramadol in people with Post-Surgical Complication, run by Sheikh Zayed Medical College.
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 2 inclusion and 8 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 5 Apr 2022. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Obaid ur rehman Reman, Mbbs (03335817980, drobaid_55@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of post spinal shivering by observing grades of shivering (time frame: 10 minutes). 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 5 Apr 2022.