Post Spinal Anesthesia ShiveringPhase 3DEXNCT06942000
Intrathecal DEX With Bupivacaine Inpost-spinal Shivering After CS.
A Phase 3 study testing dexmedetomidine 3mcg group, dexmedetomidine 5mcg and preservative-free 0.9% saline. in people with Post Spinal Anesthesia Shivering, run by Al-Azhar University at 2 sites in Egypt.
Trial summary
This prospective, randomized, double-blind, placebo-controlled study to determine whether intrathecal dexmedetomidine, administered along with hyperbaric bupivacaine for covering Cesarean delivery decreases the incidence of shivering associated with spinal anesthesia Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Post Spinal Anesthesia Shivering
- What is being tested?
- dexmedetomidine 3mcg group, dexmedetomidine 5mcg and preservative-free 0.9% saline.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 May 2025to 30 Dec 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Full-term pregnant women undergoing elective cesarean section under spinal anesthesia.
- singleton pregnancy
- Age: 20 ~ 40 years;
- ASA physical status II ~ III;
Who cannot join
- parturient less than 20 years and more than 40 years.
- History of uncontrolled comorbidities, cardiac (e.g., pre-eclampsia and hypertension), respiratory, renal or hepatic disease.
- parturients who had allergy to any medication in the study.
- parturients with contraindications to spinal anesthesia (coagulation disorder, infection at site of puncture, raised intracranial tension or any spine deformity)
- parturient who has history of alcohol intake.
- parturient received any medication likely to affect thermoregulation or Veno dilation.
- Refusing to sign informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
Faculty of Medicine, Al-Azhar University, Assiut, Egypt
Asyut, 71523
Mohamed A. Mahmoud, MD, 01002538320 ext. 002, mohamedali.226@azhar.edu.eg
Osama M. Fathy, ( M.B.B.CH), 01002538320 ext. 002, mohamedali.226@azhar.edu.eg
Mohamed Ali Mahmoud
Asyut, 71523
Mohamed A Mahmoud, 01002538320, mohamedali.226@azhar.edu.eg
About this study
Official title: Efficacy of Dexmedetomidine as Adjuvant to Intrathecal Bupivacaine in Decreasing Incidence of Post-spinal Shivering in Pregnant Women Undergoing Cesarean Section.
This prospective, randomized, double-blind, placebo-controlled study to determine whether intrathecal dexmedetomidine, administered along with hyperbaric bupivacaine for covering Cesarean delivery decreases the incidence of shivering associated with spinal anesthesia
Read the detailed description
The study will be carried out at AL Azhar University Hospitals (Assiut) on 120 parturients belonging to ASA physical status I and II undergoing an elective cesarean delivery under spinal anesthesia procedure.
Sample size was determined by department of statistics of faculty of medicine, Al-Azhar university (Assiut).
Randomization, blinding and allocation concealment parturients will be randomly assigned into three equal groups (40 parturients for each group). According to the random number generated by computer, parturient were randomly allocated into three equal groups (40 parturients for each group) to receive either dexmedetomidine 3mcg, dexmedetomidine 5mcg or normal saline in combination with bupivacaine. The randomization sequence was placed in serially numbered opaque envelopes. Before the start of spinal anesthesia, an anesthesiologist who would not involve in the study will prepare relevant drugs according to the randomization sequence
- Conditions
- Post Spinal Anesthesia Shivering
- Being tested
- dexmedetomidine 3mcg group, dexmedetomidine 5mcg, preservative-free 0.9% saline.
- Keywords
- Cesarean Section, Dexmedetomidine, Intrathecal Anesthesia, Shivering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine 3mcg groupDrug
3mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline.
dexmedetomidine 5mcgDrug
5mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline.
preservative-free 0.9% saline.Drug
(0.5 ml) preservative-free 0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| Group D3: (dexmedetomidine 3mcg group) | Active comparator | parturients will receive spinal anesthesia consisting of 2ml (10mg) of 0.5% hyperbaric bupivacaine . Receives: Drug: dexmedetomidine 3mcg group |
| Group D5: (dexmedetomidine 5mcg group) | Active comparator | parturients will receive spinal anesthesia consisting of 2ml (10mg) of 0.5% hyperbaric bupivacaine . Receives: Drug: dexmedetomidine 5mcg |
| Group C: (Control group) | Placebo comparator | parturients will receive spinal anesthesia consisting of 2 ml (10 mg) of 0.5% hyperbaric bupivacaine. Receives: Drug: preservative-free 0.9% saline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy on the incidence and severity of shivering associated with spinal anesthesia.
evaluate the effect of intrathecal dexmedetomidine, administered as an adjunct to hyperbaric bupivacaine for Cesarean delivery, on the incidence and severity of shivering associated with spinal anesthesia.
Measured: Shivering will be measured at the following time points: (Immediately after spinal anesthesia, and at 5, 10, 15, 20, 30, 40, 50, 60 and 90 minutes later
Secondary outcomes (1)
incidence of adverse effects
the incidence of adverse effects, including nausea, vomiting, bradycardia, hypotension and sedation.
Measured: Immediately after spinal anesthesia, and within 90 minutes later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Spinal Anesthesia ShiveringStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parturients will be randomly assigned into three equal groups (40 parturients for each group). According to the random number generated by computer, parturient were randomly allocated into three equal groups (40 parturients for each group) to receive either dexmedetomidine 3mcg, dexmedetomidine 5mcg or normal saline in combination with bupivacaine. The randomization sequence was placed in serially numbered opaque envelopes. Before the start of spinal anesthesia, an anesthesiologist who would not involve in the study will prepare relevant drugs according to the randomization sequence.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ali Mahmoud, Al-Azhar University
- Investigators
- Osama H. Ahmed, MD, Study director, Professor at Faculty of Medicine, Al-Azhar University, Assiut, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942000
- Sponsor's protocol ID
- MSC/AZAST/API029/2/239/1/2025.
- Acronym
- DEX
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available with corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dexmedetomidine as Adjuvant to Intrathecal Bupivacaine in Decreasing Incidence of Post-spinal Shivering in Pregnant Women Undergoing Cesarean Section.
- ClinicalTrials.gov ID
- NCT06942000
- Acronym / sponsor ID
- DEX / MSC/AZAST/API029/2/239/1/2025.
- Conditions
- Post Spinal Anesthesia Shivering
- Keywords
- Cesarean Section, Dexmedetomidine, Intrathecal Anesthesia, Shivering
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 24 Apr 2025 (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.
This prospective, randomized, double-blind, placebo-controlled study to determine whether intrathecal dexmedetomidine, administered along with hyperbaric bupivacaine for covering Cesarean delivery decreases the incidence of shivering associated with spinal anesthesia
Detailed description
The study will be carried out at AL Azhar University Hospitals (Assiut) on 120 parturients belonging to ASA physical status I and II undergoing an elective cesarean delivery under spinal anesthesia procedure.
Sample size was determined by department of statistics of faculty of medicine, Al-Azhar university (Assiut).
Randomization, blinding and allocation concealment parturients will be randomly assigned into three equal groups (40 parturients for each group). According to the random number generated by computer, parturient were randomly allocated into three equal groups (40 parturients for each group) to receive either dexmedetomidine 3mcg, dexmedetomidine 5mcg or normal saline in combination with bupivacaine. The randomization sequence was placed in serially numbered opaque envelopes. Before the start of spinal anesthesia, an anesthesiologist who would not involve in the study will prepare relevant drugs according to the randomization sequence
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- parturients will be randomly assigned into three equal groups (40 parturients for each group). According to the random number generated by computer, parturient were randomly allocated into three equal groups (40 parturients for each group) to receive either dexmedetomidine 3mcg, dexmedetomidine 5mcg or normal saline in combination with bupivacaine. The randomization sequence was placed in serially numbered opaque envelopes. Before the start of spinal anesthesia, an anesthesiologist who would not involve in the study will prepare relevant drugs according to the randomization sequence.
| Arm | Type | Receives |
|---|---|---|
| Group D3: (dexmedetomidine 3mcg group) | Active comparator | Drug: dexmedetomidine 3mcg groupparturients will receive spinal anesthesia consisting of 2ml (10mg) of 0.5% hyperbaric bupivacaine . |
| Group D5: (dexmedetomidine 5mcg group) | Active comparator | Drug: dexmedetomidine 5mcgparturients will receive spinal anesthesia consisting of 2ml (10mg) of 0.5% hyperbaric bupivacaine . |
| Group C: (Control group) | Placebo comparator | Drug: preservative-free 0.9% saline.parturients will receive spinal anesthesia consisting of 2 ml (10 mg) of 0.5% hyperbaric bupivacaine. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Full-term pregnant women undergoing elective cesarean section under spinal anesthesia.
- singleton pregnancy
- Age: 20 ~ 40 years;
- ASA physical status II ~ III;
Key exclusion criteria (7 listed)
- parturient less than 20 years and more than 40 years.
- History of uncontrolled comorbidities, cardiac (e.g., pre-eclampsia and hypertension), respiratory, renal or hepatic disease.
- parturients who had allergy to any medication in the study.
- parturients with contraindications to spinal anesthesia (coagulation disorder, infection at site of puncture, raised intracranial tension or any spine deformity)
- parturient who has history of alcohol intake.
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 |
|---|---|---|
| dexmedetomidine 3mcg group3mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline. | Drug | Group D3: (dexmedetomidine 3mcg group) |
| dexmedetomidine 5mcg5mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline. | Drug | Group D5: (dexmedetomidine 5mcg group) |
| preservative-free 0.9% saline.(0.5 ml) preservative-free 0.9% saline | Drug | Group C: (Control group) |
Primary outcome
efficacy on the incidence and severity of shivering associated with spinal anesthesia.
Time frame: Shivering will be measured at the following time points: (Immediately after spinal anesthesia, and at 5, 10, 15, 20, 30, 40, 50, 60 and 90 minutes later
evaluate the effect of intrathecal dexmedetomidine, administered as an adjunct to hyperbaric bupivacaine for Cesarean delivery, on the incidence and severity of shivering associated with spinal anesthesia.
1 secondary outcome
incidence of adverse effects
Time frame: Immediately after spinal anesthesia, and within 90 minutes later
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 24 Apr 2025.
- Individual participant dataSharing planned: No. Data is available with corresponding author on reasonable request
Related trials for Post Spinal Anesthesia Shivering
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Two Doses of IV Magnesium Sulfate for Prevention of Post-Spinal Shivering
Post Spinal Anesthesia Shivering
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Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries
Shivering, Postoperative Shivering
Not yet recruitingPhase 4
Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia
Shivering, Hypothermia
Not yet recruitingPhase 4
Intravenous Paracetamol Versus Magnesium Sulfate for Control of Shivering Following Spinal Anesthesia in Cesarean Section
Shivering, Post-Spinal Shivering
Not yet recruitingPhase 4
Efficacy of Intravenous Midazolam-Ketamine Combination Versus Placebo for Prevention of Post-Spinal Shivering in Elective Cesarean Section
Shivering, Post-Spinal 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.
Osama H. Ahmed, MD study director
Professor at Faculty of Medicine, Al-Azhar University, Assiut, Egypt
2 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 dexmedetomidine 3mcg group, dexmedetomidine 5mcg and preservative-free 0.9% saline. in people with Post Spinal Anesthesia Shivering, run by Al-Azhar University at 2 sites in Egypt.
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 7 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 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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. Some participants in this study may receive a placebo. 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 Mohamed A. Mahmoud, MD (01002538320 ext. 002, mohamedali.226@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy on the incidence and severity of shivering associated with spinal anesthesia. (time frame: Shivering will be measured at the following time points: (Immediately after spinal anesthesia, and at 5, 10, 15, 20, 30, 40, 50, 60 and 90 minutes later). 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 24 Apr 2025.