Shivering, Spinal AnesthesiaNCT07377903
Post Operative Shivering Following Anesthesia
A study testing Dexmedetomidin, Mg (magnesium sulfate) and Ondansetron 8 mg in people with Shivering, Spinal Anesthesia, run by Sohag University.
Trial summary
The aim of this study is to compare the efficacy of magnesium sulphate, ondansetron, and dexmedetomidine in managing post-spinal anesthesia shivering. The primary aim is the time to cessation of shivering after drug administration, while secondary aim include hemodynamic parameters (heart rate, blood pressure, SpO₂ )… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Shivering, Spinal Anesthesia
- What is being tested?
- Dexmedetomidin, Mg (magnesium sulfate) and Ondansetron 8 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Sep 2026
- Phase
- Interventional
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age from 18 to 45 years.
- Both sexes.
- American Society of Anesthesiologists physical status I, II
- Scheduled for elective lower abdominal or lower limb surgeries under spinal anesthesia
Who cannot join
- Patients with known allergy to study drugs.
- Patients with baseline body temperature outside the normal range (36-37.5°C).
- History of thermoregulatory disorders, thyroid dysfunction, or neurological diseases.
- Patients receive sedatives, antipsychotics, or antidepressants.
- Patients require intraoperative conversion to general anesthesia.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Aya Mohammed Aboelwafa, Resident of anesthesia contact
About this study
Official title: Pharmacological Management of Post Operative Shivering Following Anesthesia
The aim of this study is to compare the efficacy of magnesium sulphate, ondansetron, and dexmedetomidine in managing post-spinal anesthesia shivering. The primary aim is the time to cessation of shivering after drug administration, while secondary aim include hemodynamic parameters (heart rate, blood pressure, SpO₂ ) and the recurrence of shivering
Read the detailed description
This is a randomized double blinded study including patients undergoing surgery under spinal anesthesia. Patients will be randomly allocated into three groups to receive magnesium sulphate, ondansetron, or dexmedetomidine for the treatment of post-spinal anesthesia shivering. The time to cessation of shivering, hemodynamic parameters, and recurrence of shivering will be recorded.
- Conditions
- Shivering, Spinal Anesthesia
- Being tested
- Dexmedetomidin, Mg (magnesium sulfate), Ondansetron 8 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidinDrug
•Group D (Dexmedetomidine Group): 0.5 µg/kg dexmedetomidine diluted in 100 mL of normal saline.
Mg (magnesium sulfate)Drug
50 mg/kg magnesium sulphate diluted in 100 mL of normal saline.
Ondansetron 8 mgDrug
8 mg ondansetron diluted in 100 mL of normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Mg sulphate group | Experimental | 50 mg/kg magnesium sulphate diluted in 100 mL of normal saline. Receives: Drug: Mg (magnesium sulfate) |
| dexmedetomidine group | Experimental | Not described Receives: Drug: Dexmedetomidin |
| ondansetron group | Experimental | Not described Receives: Drug: Ondansetron 8 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to cessation of shivering after drug administration.
Grade 0: No shivering.
- Grade 1: Piloerection or peripheral vasoconstriction but no visible shivering. 4
- Grade 2: Muscular activity in only one muscle group.
- Grade 3: Muscular activity in more than one muscle group.
- Grade 4: Whole-body shivering.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Muhammad Aboelwafa, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377903
- Sponsor's protocol ID
- Soh_med__25_12_10MS
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding sharing individual participant data has not yet been made. This will depend on future agreements, ethical approvals, and data governance policies.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Management of Post Operative Shivering Following Anesthesia
- ClinicalTrials.gov ID
- NCT07377903
- Acronym / sponsor ID
- Soh_med__25_12_10MS
- Conditions
- Shivering, Spinal Anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 30 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.
The aim of this study is to compare the efficacy of magnesium sulphate, ondansetron, and dexmedetomidine in managing post-spinal anesthesia shivering. The primary aim is the time to cessation of shivering after drug administration, while secondary aim include hemodynamic parameters (heart rate, blood pressure, SpO₂ ) and the recurrence of shivering
Detailed description
This is a randomized double blinded study including patients undergoing surgery under spinal anesthesia. Patients will be randomly allocated into three groups to receive magnesium sulphate, ondansetron, or dexmedetomidine for the treatment of post-spinal anesthesia shivering. The time to cessation of shivering, hemodynamic parameters, and recurrence of shivering will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mg sulphate group | Experimental | Drug: Mg (magnesium sulfate)50 mg/kg magnesium sulphate diluted in 100 mL of normal saline. |
| dexmedetomidine group | Experimental | Drug: Dexmedetomidin |
| ondansetron group | Experimental | Drug: Ondansetron 8 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age from 18 to 45 years.
- Both sexes.
- American Society of Anesthesiologists physical status I, II
- Scheduled for elective lower abdominal or lower limb surgeries under spinal anesthesia
Key exclusion criteria (5 listed)
- Patients with known allergy to study drugs.
- Patients with baseline body temperature outside the normal range (36-37.5°C).
- History of thermoregulatory disorders, thyroid dysfunction, or neurological diseases.
- Patients receive sedatives, antipsychotics, or antidepressants.
- Patients require intraoperative conversion to general anesthesia.
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 |
|---|---|---|
| Dexmedetomidin•Group D (Dexmedetomidine Group): 0.5 µg/kg dexmedetomidine diluted in 100 mL of normal saline. | Drug | dexmedetomidine group |
| Mg (magnesium sulfate)50 mg/kg magnesium sulphate diluted in 100 mL of normal saline. | Drug | Mg sulphate group |
| Ondansetron 8 mg8 mg ondansetron diluted in 100 mL of normal saline. | Drug | ondansetron group |
Primary outcome
Time to cessation of shivering after drug administration.
Time frame: 6 hours
Grade 0: No shivering. * Grade 1: Piloerection or peripheral vasoconstriction but no visible shivering. 4 * Grade 2: Muscular activity in only one muscle group. * Grade 3: Muscular activity in more than one muscle group. * Grade 4: Whole-body shivering.
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 4 Feb 2026.
- Individual participant dataSharing planned: Undecided. A decision regarding sharing individual participant data has not yet been made. This will depend on future agreements, ethical approvals, and data governance policies.
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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.
Aya Mohammed Aboelwafa, Resident of anesthesia contact
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidin, Mg (magnesium sulfate) and Ondansetron 8 mg in people with Shivering, Spinal Anesthesia, run by Sohag 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 4 Feb 2026. 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.
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 Aya Mohammed Aboelwafa, Resident of anesthesia (01095848062 ext. 01002181828, aya_muhammad_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to cessation of shivering after drug administration. (time frame: 6 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 4 Feb 2026.