Post-Spinal ShiveringPhase 3NCT07327879
Comparative Dose-Response of Intrathecal Dexmedetomidine for Post-Spinal Shivering
A Phase 3 study testing Group D2.5 (Low-Dose Dexmedetomidine Group), Group D5 (Moderate-Dose Dexmedetomidine Group) and Group D10 (Higher-Dose Dexmedetomidine Group) in people with Post-Spinal Shivering, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Dexmedetomidine, a highly selective α2-adrenergic agonist, when used intrathecally as an adjuvant to local anesthetics, prolongs sensory/motor block and may blunt thermoregulatory shivering mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-Spinal Shivering
- What is being tested?
- Group D2.5 (Low-Dose Dexmedetomidine Group), Group D5 (Moderate-Dose Dexmedetomidine Group) and Group D10 (Higher-Dose Dexmedetomidine Group)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jan 2026to 30 Dec 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age 18-75 years)
- Scheduled for ureteric stone removal surgery
- ASA(American Society of Anesthesiologists) physical status I, II, or III
- Able to provide informed consent
Who cannot join
- Known allergy to dexmedetomidine, bupivacaine, or other study medications
- Preexisting bradycardia (heart rate <50 beats per minute)
- Second- or third-degree atrioventricular (AV) block without a pacemaker
- Severe hepatic dysfunction
- Uncontrolled hypotension
- Pregnancy
Show all 10Show fewer
- Chronic use of α₂-agonists or antagonists (e.g., clonidine, tizanidine)
- Infection at the planned spinal puncture site
- Coagulopathy or bleeding disorder
- Inability to rate or communicate shivering (e.g., language barrier, cognitive impairment)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Al-Azhar University
Cairo, Egypt, 11865
Neveen A. Kohaf, PhD, 01060383012, nevenabdo@azhar.edu.eg
Hany Baumy, M.D
About this study
Official title: Comparative Efficacy and Dose-Response of Intrathecal Dexmedetomidine in Attenuating Post-Spinal Shivering: Double-Blinded Randomized Controlled Trial
Dexmedetomidine, a highly selective α2-adrenergic agonist, when used intrathecally as an adjuvant to local anesthetics, prolongs sensory/motor block and may blunt thermoregulatory shivering mechanisms. Several randomized controlled trials and meta-analyses have demonstrated decreased shivering incidence with intrathecal dexmedetomidine, but reported doses vary (commonly 2.5, 5, and 10 µg, and in some trials up to 15-20 µg), and the balance between efficacy and adverse effects (sedation, bradycardia, and hypotension) is not fully established. Hence, a head-to-head randomized comparison of several low-to-moderate intrathecal doses is warranted.
Objective: to compare the safety and efficacy of three intrathecal dexmedetomidine doses (2.5 µg, 5 µg, 10 µg) versus placebo for the prevention of post-spinal shivering.
- Conditions
- Post-Spinal Shivering
- Being tested
- Group P (Placebo Control Group), Group D2.5 (Low-Dose Dexmedetomidine Group), Group D5 (Moderate-Dose Dexmedetomidine Group), Group D10 (Higher-Dose Dexmedetomidine Group)
- Keywords
- Intrathecal Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group P (Placebo Control Group)Drug
Patients in this group will receive the standard spinal anesthetic consisting of hyperbaric bupivacaine 0.5% (15 mg) combined with an equivalent volume of normal saline (0.9% NaCl), containing no active dexmedetomidine. The total intrathecal injection volume will be standardized to 3.5 mL across all groups by adjusting the volume of saline added. This group serves as the control to establish the baseline incidence and characteristics of post-spinal shivering and block dynamics without the intervention of the α2-adrenergic agonist.
Group D2.5 (Low-Dose Dexmedetomidine Group)Drug
Patients in this group will receive the standard spinal anesthetic (15 mg hyperbaric bupivacaine 0.5%) supplemented with a low dose of 2.5 µg of dexmedetomidine. Normal saline will be added to achieve the standardized total intrathecal volume of 3.5 mL.
Group D5 (Moderate-Dose Dexmedetomidine Group)Drug
Patients in this group will receive the standard spinal anesthetic combined with a moderate dose of 5 µg of dexmedetomidine. The total volume will be adjusted to 3.5 mL with normal saline.
Group D10 (Higher-Dose Dexmedetomidine Group)Drug
Patients in this group will receive the standard spinal anesthetic supplemented with a higher dose of 10 µg of dexmedetomidine, with normal saline used to standardize the total volume to 3.5 mL.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Placebo comparator | Patients in this group will receive the standard spinal anesthetic consisting of hyperbaric bupivacaine 0.5% (15 mg) combined with an equivalent volume of normal saline (0.9% NaCl), containing no active dexmedetomidine. The total intrathecal injection volume will be standardized to 3.5 mL across all groups by adjusting the volume of saline added. Receives: Drug: Group P (Placebo Control Group) |
| Group D2.5 | Experimental | Patients in this group will receive the standard spinal anesthetic (15 mg hyperbaric bupivacaine 0.5%) supplemented with a low dose of 2.5 µg of dexmedetomidine. Normal saline will be added to achieve the standardized total intrathecal volume of 3.5 mL. Receives: Drug: Group D2.5 (Low-Dose Dexmedetomidine Group) |
| Group D5 | Experimental | Patients in this group will receive the standard spinal anesthetic combined with a moderate dose of 5 µg of dexmedetomidine. The total volume will be adjusted to 3.5 mL with normal saline. Receives: Drug: Group D5 (Moderate-Dose Dexmedetomidine Group) |
| Group D10 | Experimental | Patients in this group will receive the standard spinal anesthetic supplemented with a higher dose of 10 µg of dexmedetomidine, with normal saline used to standardize the total volume to 3.5 mL. Receives: Drug: Group D10 (Higher-Dose Dexmedetomidine Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically significant shivering
Incidence of clinically significant shivering within 60 minutes after spinal injection, defined as Crossley and Mahajan shivering scale grade ≥2 (scale 0-4)The highest intensity of shivering experienced by the patient, scored on the 0-4 scale. The Crossley and Mahajan shivering scale is a clinically validated, four-grade ordinal scale (0-4) used to objectively quantify the severity of post-anesthetic shivering. It is defined as follows: Grade 0 signifies no shivering; Grade 1 indicates mild, intermittent fasciculations of the face, neck, or chest; Grade 2 represents visible, intermittent shivering involving more than one muscle group; Grade 3 denotes generalized, continuous shivering of the whole body; and Grade 4 describes gross, bed-shaking tremors that interfere with monitoring or procedure. Grade ≥2 is typically considered clinically significant and often triggers therapeutic intervention. The scale is assessed through direct visual observation of the patient by trained personnel.
Measured: Throughout the intraoperative period until 60 minutes post-spinal.
Secondary outcomes (6)
Time to first shivering episode
The duration from the completion of the spinal injection to the onset of the first observable shivering (any grade).
Measured: Intraoperative period, up to 60 minutes post-spinal.
Requirement of rescue anti-shivering drug
the number of patients required pharmacologic intervention (meperidine or tramadol) to treat severe shivering.
Measured: Intraoperative period, as needed.
Dose of rescue anti-shivering drug
The total amount of pharmacologic intervention (meperidine or tramadol) to treat severe shivering.
Measured: Intraoperative period, as needed.
Sedation level
The Ramsey Sedation Scale (RSS) is a simple, widely used six-level clinical tool (scores 1-6) for assessing a patient's level of sedation and responsiveness. It is scored as follows: 1 - Patient is anxious, agitated, or restless; 2 - Patient is cooperative, oriented, and tranquil; 3 - Patient responds only to commands; 4 - Patient exhibits a brisk response to a light glabellar tap or loud auditory stimulus; 5 - Patient exhibits a sluggish response to such a stimulus; and 6 - Patient exhibits no response to stimulus.
Measured: Postoperative 24 hour
Patient satisfaction
The patient's overall satisfaction with the anesthesia experience.Using a Likert scale (e.g., 1-5 or 1-10) or a standardized satisfaction questionnaire.
Measured: Postoperatively (e.g., prior to discharge from PACU).
Time to first analgesic request
The duration from the end of surgery until the patient first requires supplemental pain medication.
Measured: 24 hours Postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start28 Jan 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Spinal 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Neveen Abd El Maksoad Kohaf, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327879
- Sponsor's protocol ID
- RC. 2.12.2025
- Status last verified
- Dec 2025
- First submitted
- 26 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared upon a reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy and Dose-Response of Intrathecal Dexmedetomidine in Attenuating Post-Spinal Shivering: Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07327879
- Acronym / sponsor ID
- RC. 2.12.2025
- Conditions
- Post-Spinal Shivering
- Keywords
- Intrathecal Dexmedetomidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 28 Jan 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 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.
Dexmedetomidine, a highly selective α2-adrenergic agonist, when used intrathecally as an adjuvant to local anesthetics, prolongs sensory/motor block and may blunt thermoregulatory shivering mechanisms. Several randomized controlled trials and meta-analyses have demonstrated decreased shivering incidence with intrathecal dexmedetomidine, but reported doses vary (commonly 2.5, 5, and 10 µg, and in some trials up to 15-20 µg), and the balance between efficacy and adverse effects (sedation, bradycardia, and hypotension) is not fully established. Hence, a head-to-head randomized comparison of several low-to-moderate intrathecal doses is warranted.
Objective: to compare the safety and efficacy of three intrathecal dexmedetomidine doses (2.5 µg, 5 µg, 10 µg) versus placebo for the prevention of post-spinal shivering.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group P | Placebo comparator | Drug: Group P (Placebo Control Group)Patients in this group will receive the standard spinal anesthetic consisting of hyperbaric bupivacaine 0.5% (15 mg) combined with an equivalent volume of normal saline (0.9% NaCl), containing no active dexmedetomidine. The total intrathecal injection volume will be standardized to 3.5 mL across all groups by adjusting the volume of saline added. |
| Group D2.5 | Experimental | Drug: Group D2.5 (Low-Dose Dexmedetomidine Group)Patients in this group will receive the standard spinal anesthetic (15 mg hyperbaric bupivacaine 0.5%) supplemented with a low dose of 2.5 µg of dexmedetomidine. Normal saline will be added to achieve the standardized total intrathecal volume of 3.5 mL. |
| Group D5 | Experimental | Drug: Group D5 (Moderate-Dose Dexmedetomidine Group)Patients in this group will receive the standard spinal anesthetic combined with a moderate dose of 5 µg of dexmedetomidine. The total volume will be adjusted to 3.5 mL with normal saline. |
| Group D10 | Experimental | Drug: Group D10 (Higher-Dose Dexmedetomidine Group)Patients in this group will receive the standard spinal anesthetic supplemented with a higher dose of 10 µg of dexmedetomidine, with normal saline used to standardize the total volume to 3.5 mL. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (age 18-75 years)
- Scheduled for ureteric stone removal surgery
- ASA(American Society of Anesthesiologists) physical status I, II, or III
- Able to provide informed consent
Key exclusion criteria (10 listed)
- Known allergy to dexmedetomidine, bupivacaine, or other study medications
- Preexisting bradycardia (heart rate <50 beats per minute)
- Second- or third-degree atrioventricular (AV) block without a pacemaker
- Severe hepatic dysfunction
- Uncontrolled hypotension
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 |
|---|---|---|
| Group P (Placebo Control Group)Patients in this group will receive the standard spinal anesthetic consisting of hyperbaric bupivacaine 0.5% (15 mg) combined with an equivalent volume of normal saline (0.9% NaCl), containing no active dexmedetomidine. The total intrathecal injection volume will be standardized to 3.5 mL across all groups by adjusting the volume of saline added. This group serves as the control to establish the baseline incidence and characteristics of post-spinal shivering and block dynamics without the intervention of the α2-adrenergic agonist. | Drug | Group P |
| Group D2.5 (Low-Dose Dexmedetomidine Group)Patients in this group will receive the standard spinal anesthetic (15 mg hyperbaric bupivacaine 0.5%) supplemented with a low dose of 2.5 µg of dexmedetomidine. Normal saline will be added to achieve the standardized total intrathecal volume of 3.5 mL. | Drug | Group D2.5 |
| Group D5 (Moderate-Dose Dexmedetomidine Group)Patients in this group will receive the standard spinal anesthetic combined with a moderate dose of 5 µg of dexmedetomidine. The total volume will be adjusted to 3.5 mL with normal saline. | Drug | Group D5 |
| Group D10 (Higher-Dose Dexmedetomidine Group)Patients in this group will receive the standard spinal anesthetic supplemented with a higher dose of 10 µg of dexmedetomidine, with normal saline used to standardize the total volume to 3.5 mL. | Drug | Group D10 |
Primary outcome
Incidence of clinically significant shivering
Time frame: Throughout the intraoperative period until 60 minutes post-spinal.
Incidence of clinically significant shivering within 60 minutes after spinal injection, defined as Crossley and Mahajan shivering scale grade ≥2 (scale 0-4)The highest intensity of shivering experienced by the patient, scored on the 0-4 scale. The Crossley and Mahajan shivering scale is a clinically validated, four-grade ordinal scale (0-4) used to objectively quantify the severity of post-anesthetic shivering. It is defined as follows: Grade 0 signifies no shivering; Grade 1 indicates mild, intermittent fasciculations of the face, neck, or chest; Grade 2 represents visible, intermittent shivering involving more than one muscle group; Grade 3 denotes generalized, continuous shivering of the whole body; and Grade 4 describes gross, bed-shaking tremors that interfere with monitoring or procedure. Grade ≥2 is typically considered clinically significant and often triggers therapeutic intervention. The scale is assessed through direct visual observation of the patient by trained personnel.
6 secondary outcomes
Time to first shivering episode
Time frame: Intraoperative period, up to 60 minutes post-spinal.
Requirement of rescue anti-shivering drug
Time frame: Intraoperative period, as needed.
Dose of rescue anti-shivering drug
Time frame: Intraoperative period, as needed.
Sedation level
Time frame: Postoperative 24 hour
Patient satisfaction
Time frame: Postoperatively (e.g., prior to discharge from PACU).
Time to first analgesic request
Time frame: 24 hours Postoperatively.
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 8 Jan 2026.
- Individual participant dataSharing planned: Yes. Data can be shared upon a reasonable request from the corresponding author
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Group D2.5 (Low-Dose Dexmedetomidine Group), Group D5 (Moderate-Dose Dexmedetomidine Group) and Group D10 (Higher-Dose Dexmedetomidine Group) in people with Post-Spinal Shivering, run by Al-Azhar University at 1 site 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 10 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 8 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 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 Neveen A Kohaf, Ph.D (+201060383012, nevenabdo@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinically significant shivering (time frame: Throughout the intraoperative period until 60 minutes post-spinal.). 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 8 Jan 2026.