Shivering, Spinal AnesthesiaPhase 3NCT06722742
Use of Iv Tramadol and Ketamine for Prevention of Post Spinal Anesthesia Shivering
A Phase 3 study testing Ketamine only and Tramadol in people with Shivering, Spinal Anesthesia, run by Liaquat National Hospital & Medical College at 3 sites in Pakistan.
Trial summary
*Ketamine:* Ketamine is a medication that can help reduce shivering by blocking certain nerve signals in the brain. It's like a "nerve blocker" that helps calm down the body's shivering response. *Tramadol:* Tramadol is a pain medication that can also help reduce shivering. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Shivering, Spinal Anesthesia
- What is being tested?
- Ketamine only and Tramadol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 3 sitesPakistan
- Study dates
- 30 Sep 2024to 30 Jan 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pateint for elective cesarean section
- Age 18 to 40 years
- ASA 1 and 2
Who cannot join
- ASA 2 and 3
- Cesarean section requiring general anesthesia
- Hypersensitivity to Ketamine, Tramadol and Opiods
- History of cardiovascular disease
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan3 sites, 3 recruiting
- Recruiting
Liaquat National Hospital and Medical College
Karachi, Sindh, 75500
Nazish Kanwal Dr Nazish Kanwal, 03292163092, Naz98783@gmail.com
Shazor Khan, +92 340 2286119, shazorkhan646@gmail.com
- Recruiting
Liaquat National Hospital and Medical College
Karachi, Sindh
Nazish Kanwal Dr nazish Kanwal, 03292163092, Naz98783@gmail.com
Shazor, +92 340 2286119, shazorkhan646@gmail.com
- Recruiting
Liaquat National Hospital and Medical College
Karachi, Sindh
Nazish Kanwal Dr Nazish kanwal, +923292163092, naz98783@gmail.com
Shahzor Khan, +923402286119, shahzorkhan646@gmail.com
About this study
Official title: Frequency of Shivering Among Patient Treaed With IV Tramadol Versus Iv Ketamine in Prevention of Post Spinal Anesthesia Undergoing Cesarean Section: Rendomiced Control Trial
*Ketamine:* Ketamine is a medication that can help reduce shivering by blocking certain nerve signals in the brain. It's like a "nerve blocker" that helps calm down the body's shivering response.
- *Tramadol:* Tramadol is a pain medication that can also help reduce shivering. It works by affecting the brain's temperature regulation centers, which helps to reduce the shivering response.
Read the detailed description
Post-spinal shivering is when a patient starts shaking or shivering after receiving spinal anesthesia. This can be uncomfortable and even scary for the patient.
Using ketamine and tramadol to reduce post-spinal shivering can have several benefits, including:
- Reduced discomfort and anxiety for the patient
- Improved patient satisfaction
- Reduced need for additional medications or interventions
- Faster recovery times
- Conditions
- Shivering, Spinal Anesthesia
- Being tested
- Ketamine only, Tramadol
- Keywords
- shivering, Spinal anesthesia, Ketamine, Tramadol and Metclopromide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine onlyDrug
Inj: Ketamine given to group K following spinal anesthesia
TramadolDrug
Inj Tramadol given to group T following spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group K | Active comparator | Group K receive Inj: ketamine Receives: Drug: Ketamine only |
| Group T | Active comparator | Group T receive Inj: Tramadol Receives: Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shivering
Scale validated by crossley and mahajan Grade 0: No shivering Grade 1: Piloerection, peripheral vasoconstriction, peripheral cyanosis, or mild fasciculation of the face or neck, but no visible muscle activity Grade 2: Visible muscle activity in one muscle group Grade 3: Visible muscle activity in more than one muscle group Grade 4: Gross muscle activity involving the entire body
Measured: 20 minutes to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start30 Sep 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shivering, Spinal AnesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazish Kanwal, Liaquat National Hospital & Medical College
- Investigators
- Nazish Dr Nazish Kanwal, Principal investigator, Liaquat national hospital and medical college
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722742
- Sponsor's protocol ID
- #882-2023-LNH-ERC
- Status last verified
- Dec 2024
- First submitted
- 28 Nov 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient confidentiality\*: Sharing IPD could compromise patient confidentiality and anonymity, potentially harming participants or their families. * Informed consent\*: Participants may not have provided informed consent for their data to be shared, which could raise ethical concerns.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Shivering Among Patient Treaed With IV Tramadol Versus Iv Ketamine in Prevention of Post Spinal Anesthesia Undergoing Cesarean Section: Rendomiced Control Trial
- ClinicalTrials.gov ID
- NCT06722742
- Acronym / sponsor ID
- #882-2023-LNH-ERC
- Conditions
- Shivering, Spinal Anesthesia
- Keywords
- shivering, Spinal anesthesia, Ketamine, Tramadol and Metclopromide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 9 Dec 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.
*Ketamine:* Ketamine is a medication that can help reduce shivering by blocking certain nerve signals in the brain. It's like a "nerve blocker" that helps calm down the body's shivering response.
- *Tramadol:* Tramadol is a pain medication that can also help reduce shivering. It works by affecting the brain's temperature regulation centers, which helps to reduce the shivering response.
Detailed description
Post-spinal shivering is when a patient starts shaking or shivering after receiving spinal anesthesia. This can be uncomfortable and even scary for the patient.
Using ketamine and tramadol to reduce post-spinal shivering can have several benefits, including:
- Reduced discomfort and anxiety for the patient
- Improved patient satisfaction
- Reduced need for additional medications or interventions
- Faster recovery times
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group K | Active comparator | Drug: Ketamine onlyGroup K receive Inj: ketamine |
| Group T | Active comparator | Drug: TramadolGroup T receive Inj: Tramadol |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pateint for elective cesarean section
- Age 18 to 40 years
- ASA 1 and 2
Key exclusion criteria (4 listed)
- ASA 2 and 3
- Cesarean section requiring general anesthesia
- Hypersensitivity to Ketamine, Tramadol and Opiods
- History of cardiovascular disease
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 |
|---|---|---|
| Ketamine onlyInj: Ketamine given to group K following spinal anesthesia | Drug | Group K |
| TramadolInj Tramadol given to group T following spinal anesthesia | Drug | Group T |
Primary outcome
Shivering
Time frame: 20 minutes to 12 hours
Scale validated by crossley and mahajan Grade 0: No shivering Grade 1: Piloerection, peripheral vasoconstriction, peripheral cyanosis, or mild fasciculation of the face or neck, but no visible muscle activity Grade 2: Visible muscle activity in one muscle group Grade 3: Visible muscle activity in more than one muscle group Grade 4: Gross muscle activity involving the entire body
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- The effect of ketamine versus tramadol on prophylactic post-spinal shivering in those patients undergoing orthopedic surgery: a prospective cohort study design, 2020 Ashebir Debalike Gemechu 1, Tsegaye Demeke Gebremedhin 1,✉, Andualem Assefa Andebiku 1,Link provided by the sponsor.
- Individual participant dataSharing planned: No. Patient confidentiality*: Sharing IPD could compromise patient confidentiality and anonymity, potentially harming participants or their families. * Informed consent*: Participants may not have provided informed consent for their data to be shared, which could raise ethical concerns.
Related trials for Shivering, Spinal Anesthesia
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Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia
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Not yet recruitingPhase 4
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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.
Nazish Dr Nazish Kanwal principal investigator
Liaquat national hospital and medical college
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine only and Tramadol in people with Shivering, Spinal Anesthesia, run by Liaquat National Hospital & Medical College at 3 sites 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: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nazish Dr Nazish Kanwal (03292163092, Naz98783@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shivering (time frame: 20 minutes to 12 hours). 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 9 Dec 2024.