ShiveringPhase 4NCT06134895
Tramadol and Tramadol Plus Ketamine for Shivering Prevention After Spinal Anesthesia in Lower Segment Caeserian Section
A Phase 4 study testing Tramadol with Ketamine and Tramadol in people with Shivering, run by Ziauddin University at 1 site in Pakistan.
Trial summary
The objective of this study is to compare the efficacy of prophylactic use of intravenous tramadol versus tramadol plus ketamine for prevention of shivering under spinal anaesthesia in lower segment caeserian section. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Shivering
- What is being tested?
- Tramadol with Ketamine and Tramadol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Aug 2023to 16 Nov 2023
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 to 40 years
- American Society of Anesthesiologist physical status I and II
- Pregnant female for lower segment caeserian section
Who cannot join
- Patients with Hypertension
- Patients with hypo- or hyperthyroidism
- Known case of Cardiopulmonary disease, pre-eclampsia and eclampsia
- An initial body temperature 38.00C or, 36.0oC assessed by thermometer
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Muhammad Arif
Karachi, Sindh
Muhammad Arif, +92 331 3455112, muhammad.aarif@zu.edu.pk
About this study
Official title: Randomised Double Blind Comparison of Prophylactic Tramadol and Tramadol Plus Ketamine for Prevention of Shivering After Spinal Anesthesia in Lower Segment Caeserian Section
The objective of this study is to compare the efficacy of prophylactic use of intravenous tramadol versus tramadol plus ketamine for prevention of shivering under spinal anaesthesia in lower segment caeserian section.
- Conditions
- Shivering
- Being tested
- Tramadol with Ketamine, Tramadol
- Keywords
- Shivering, Anesthesia, Spinal, Caesarean
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol with KetamineDrug
Tramadol with Ketamine is being provided randomly using prospective, double-blind
TramadolDrug
Tramadol alone is being provided randomly using prospective, double-blind
| Study group | Role | What they receive |
|---|---|---|
| Tramadol with Ketamine | Experimental | Tramadol 0.25mg/Kg with Ketamine 0.25 mg/Kg Receives: Drug: Tramadol with Ketamine |
| Tramadol | Active comparator | Tramadol 0.5mg/kg Receives: Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of shivering
Muscular activity in one or more than one muscle group or involving the whole body will be labelled as shivering
Measured: Patients will be monitored from 15-45 mins from the administration of the prophylactic drug
Severity of Shivering
Shivering will be graded as per the following criteria:
0= no shivering.
- piloerection or peripheral vasoconstriction but no visible shivering.
- muscular activity (visible muscular twitching) in only one muscle group;
- muscular (visible muscular twitching) activity in more than one muscle group but not generalized.
- shivering involving the whole body
Measured: Patients will be monitored from 15-45 mins from the administration of the prophylactic drug
Secondary outcomes (2)
Time to shivering
The time to shiver will be defined as the duration from the initiation of the intervention until the onset of observable shivering.
Measured: 15 mins from the administration of the prophylactic drug
Complications
Complications such as hypotension, nausea and vomiting, bradycardia, or hallucinations will be noted
Measured: Patients will be monitored from 15-45 mins from the administration of the prophylactic drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start16 Aug 2023
- Primary completion16 Nov 2023 (estimated)
- Study completion16 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShiveringStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Muhammad Arif, Ziauddin University
- Investigators
- Muhammad Arif, Principal investigator, Ziauddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134895
- Sponsor's protocol ID
- 7240623MAANE
- Status last verified
- Nov 2023
- First submitted
- 11 Sep 2023
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Double Blind Comparison of Prophylactic Tramadol and Tramadol Plus Ketamine for Prevention of Shivering After Spinal Anesthesia in Lower Segment Caeserian Section
- ClinicalTrials.gov ID
- NCT06134895
- Acronym / sponsor ID
- 7240623MAANE
- Conditions
- Shivering
- Keywords
- Shivering, Anesthesia, Spinal, Caesarean
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 16 Nov 2023 (estimated)
- Study completion
- 16 Nov 2023 (estimated)
- First posted
- 18 Nov 2023 (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 objective of this study is to compare the efficacy of prophylactic use of intravenous tramadol versus tramadol plus ketamine for prevention of shivering under spinal anaesthesia in lower segment caeserian section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tramadol with Ketamine | Experimental | Drug: Tramadol with KetamineTramadol 0.25mg/Kg with Ketamine 0.25 mg/Kg |
| Tramadol | Active comparator | Drug: TramadolTramadol 0.5mg/kg |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 to 40 years
- American Society of Anesthesiologist physical status I and II
- Pregnant female for lower segment caeserian section
Key exclusion criteria (4 listed)
- Patients with Hypertension
- Patients with hypo- or hyperthyroidism
- Known case of Cardiopulmonary disease, pre-eclampsia and eclampsia
- An initial body temperature 38.00C or, 36.0oC assessed by thermometer
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 |
|---|---|---|
| Tramadol with KetamineTramadol with Ketamine is being provided randomly using prospective, double-blind | Drug | Tramadol with Ketamine |
| TramadolTramadol alone is being provided randomly using prospective, double-blind | Drug | Tramadol |
Primary outcome
Incidence of shivering
Time frame: Patients will be monitored from 15-45 mins from the administration of the prophylactic drug
Muscular activity in one or more than one muscle group or involving the whole body will be labelled as shivering
Severity of Shivering
Time frame: Patients will be monitored from 15-45 mins from the administration of the prophylactic drug
Shivering will be graded as per the following criteria: 0= no shivering. 1. piloerection or peripheral vasoconstriction but no visible shivering. 2. muscular activity (visible muscular twitching) in only one muscle group; 3. muscular (visible muscular twitching) activity in more than one muscle group but not generalized. 4. shivering involving the whole body
2 secondary outcomes
Time to shivering
Time frame: 15 mins from the administration of the prophylactic drug
Complications
Time frame: Patients will be monitored from 15-45 mins from the administration of the prophylactic drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Shivering
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Effect Of Acupressure On Hypothermıa And Shıverıng After Cesarean Sectıon
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Not yet recruitingPhase 4
Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries
Shivering, Postoperative Shivering
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.
Muhammad Arif principal investigator
Ziauddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tramadol with Ketamine and Tramadol in people with Shivering, run by Ziauddin University at 1 site in Pakistan.
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 4 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 18 Nov 2023. 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 Pakistan. 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. 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 Muhammad Arif (+92 331 3455112, muhammad.aarif@zu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of shivering (time frame: Patients will be monitored from 15-45 mins from the administration of the prophylactic drug). The study lists 2 primary outcomes in all. 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 18 Nov 2023.