Shivering Caused by Spinal AnesthesiaPhase 4NCT07332572
COMPARISON OF INTRAVENOUS DEXMEDETOMEDINE AND TRAMADOL FOR POST OPERATIVE SHIVERING AFTER SPINAL ANESTHESIA FOR CAESAREAN SECTION
A Phase 4 study testing Tramadol and Dexmedetomidine in people with Shivering Caused by Spinal Anesthesia, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial summary
To compare the mean time of cessation of post-operative shivering after receiving intravenous dexmedetomidine versus tramadol in patients undergoing caesarean delivery under spinal anaesthesia. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Shivering Caused by Spinal Anesthesia
- What is being tested?
- Tramadol and Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2025to 15 Dec 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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant
- Grade 3 or 4 Shivering
Who cannot join
- Hypothyroidism
- Known allergies to drugs
Trial locations and contacts
1 site in 1 country.
About this study
To compare the mean time of cessation of post-operative shivering after receiving intravenous dexmedetomidine versus tramadol in patients undergoing caesarean delivery under spinal anaesthesia.
- Conditions
- Shivering Caused by Spinal Anesthesia
- Being tested
- Tramadol, Dexmedetomidine
- Keywords
- Shivering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
Comparative study of tramadol with dexmedetomedine
DexmedetomidineDrug
comparative study of tramadol and dexmed
| Study group | Role | What they receive |
|---|---|---|
| Tramadol group | Active comparator | Tramadol Receives: Drug: Tramadol; Drug: Dexmedetomidine |
| Dexmedetomidine group | Active comparator | Dexmedetomedine group Receives: Drug: Tramadol; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
SHIVERING TIME
Will assess the cessation time between two groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Jun 2025
- Primary completion1 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shivering Caused by 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shavez Noor, Liaquat National Hospital & Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332572
- Sponsor's protocol ID
- LNH
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF INTRAVENOUS DEXMEDETOMEDINE AND TRAMADOL FOR POST OPERATIVE SHIVERING AFTER SPINAL ANESTHESIA FOR CAESAREAN SECTION
- ClinicalTrials.gov ID
- NCT07332572
- Acronym / sponsor ID
- LNH
- Conditions
- Shivering Caused by Spinal Anesthesia
- Keywords
- Shivering
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 12 Jan 2026 (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 compare the mean time of cessation of post-operative shivering after receiving intravenous dexmedetomidine versus tramadol in patients undergoing caesarean delivery under spinal anaesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tramadol group | Active comparator | Drug: Tramadol, Drug: DexmedetomidineTramadol |
| Dexmedetomidine group | Active comparator | Drug: Tramadol, Drug: DexmedetomidineDexmedetomedine group |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant
- Grade 3 or 4 Shivering
Key exclusion criteria (2 listed)
- Hypothyroidism
- Known allergies to 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 |
|---|---|---|
| TramadolComparative study of tramadol with dexmedetomedine | Drug | Dexmedetomidine group, Tramadol group |
| Dexmedetomidinecomparative study of tramadol and dexmed | Drug | Dexmedetomidine group, Tramadol group |
Primary outcome
SHIVERING TIME
Time frame: 6 months
Will assess the cessation time between two groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Dexmedetomidine in people with Shivering Caused by Spinal Anesthesia, run by Liaquat National Hospital & Medical College 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 12 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SHIVERING TIME (time frame: 6 months). 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 12 Jan 2026.