Effects of Dexmedetomidine & Magnesium Sulphate on Patients Undergoing DHSPhase 3NCT07326397
Comparison Between Intrathecal Magnesium Sulphate & Dexmedetomidine in DHS
A Phase 3 study testing Dexmedetomidine and Magnesium Sulphate in people with Effects of Dexmedetomidine & Magnesium Sulphate on Patients Undergoing DHS, run by Assiut University.
Trial summary
To compare the efficacy and safety of intrathecal dexmedetomidine and magnesium sulphate as adjuvants to 0.5% hyperbaric bupivacaine in patients undergoing elective DHS fixation, focusing on onset and duration of sensory and motor block, hemodynamic stability, and quality of postoperative analgesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Effects of Dexmedetomidine & Magnesium Sulphate on Patients Undergoing DHS
- What is being tested?
- Dexmedetomidine and Magnesium Sulphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Dec 2027
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65 year
- ASA Physical Status I or II
- Scheduled for elective DHS fixation under spinal anesthesia
- Written informed consent provided
- Patients of both sex are included in the study.
Who cannot join
- Patient refusal
- Allergy to study drugs
- Local infection at injection site
- Neurological or psychiatric illness
- Coagulopathy
- Chronic opioid or sedative use
About this study
Official title: Comparative Evaluation of Intrathecal Dexmedetomidine and Magnesium Sulphate as Adjuvants to 0.5% Hyperbaric Bupivacaine for Spinal Anesthesia in Patients Undergoing Dynamic Hip Screw (DHS) Fixation: A Randomized Clinical Study
To compare the efficacy and safety of intrathecal dexmedetomidine and magnesium sulphate as adjuvants to 0.5% hyperbaric bupivacaine in patients undergoing elective DHS fixation, focusing on onset and duration of sensory and motor block, hemodynamic stability, and quality of postoperative analgesia.
Read the detailed description
Spinal anesthesia is a preferred technique for lower limb orthopedic surgeries due to its rapid onset, reliable sensory and motor blockade, and minimal systemic side effects. Hyperbaric bupivacaine 0.5% is commonly used; however, its duration may be insufficient for prolonged procedures or postoperative analgesia. To enhance and prolong anesthesia and analgesia, various intrathecal adjuvants have been investigated.
Dexmedetomidine, a selective α2-adrenergic agonist, has shown promise in improving the quality and duration of spinal anesthesia by providing prolonged sensory and motor blockade, stable hemodynamics, and enhanced postoperative analgesia. Similarly, magnesium sulphate, an NMDA receptor antagonist, exerts antinociceptive effects by modulating calcium influx in nerve cells, potentially prolonging analgesia without significant motor blockade.
Dynamic hip screw (DHS) fixation is a common surgical intervention for intertrochanteric femur fractures, particularly in elderly patients. These procedures demand reliable intraoperative anesthesia and effective postoperative pain control to facilitate early mobilization and reduce complications.
Despite individual studies evaluating these agents, direct comparisons between intrathecal dexmedetomidine and magnesium sulphate as adjuvants to bupivacaine in DHS fixation remain limited. This study aims to compare their efficacy and safety in enhancing spinal anesthesia, thereby optimizing perioperative care in patients undergoing elective DHS fixation.
- Being tested
- Dexmedetomidine, Magnesium Sulphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
2.5 mL 0.5% hyperbaric bupivacaine + 5 µg dexmedetomidine (0.5 mL), total volume 3 mL
Magnesium SulphateDrug
2.5 mL 0.5% hyperbaric bupivacaine + 50 mg magnesium sulphate (0.5 mL), total volume 3 mL
| Study group | Role | What they receive |
|---|---|---|
| Group D (Dexmedetomidine) | Active comparator | Not described Receives: Drug: Dexmedetomidine |
| Group M (Magnesium Sulphate) | Active comparator | Not described Receives: Drug: Magnesium Sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highest Dermatome Level of Sensory Block
Sensory block level assessed using a pinprick test and recorded as the highest dermatome level with loss of sensation.
Measured: 24 hours after intervention
Duration of postoperative analgesia
The outcome is Measured by Vas Score to assess pain intensity. It consists of a numeric version of the visual analogue scale. It is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. This scale can be administered verbally. Vas score for 24 h will be assessed at 0., 1, 12 and 24 h postoperatively and will be recorded.
Measured: 24 hours after intervention
Degree of Motor Block
Motor block assessed using the Modified Bromage Scale (0-3), where higher scores indicate greater motor block.
Measured: 24 hours after intervention
Secondary outcomes (4)
Heart Rate
Heart rate measured in beats per minute (bpm)
Measured: 24 hours after intervention
Incidence of Adverse Effects
Bradycardia Hypotension Nausea Vomiting Sedation (Assessed By Ramsay Sedation Scale (RSS) ) Shivering Respiratory depression Delayed motor block Flushing Warm sensation Headache Pruritus Urinary retention Neurological complications (e.g., transient paresthesia)
Measured: 24 hours after Intervention
Mean Arterial Pressure
Mean arterial pressure measured in mmHg
Measured: 24 hours after intervention
Oxygen Saturation
Peripheral oxygen saturation measured by pulse oximetry by percentage
Measured: 24 hours after intervention
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 start1 Feb 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of Dexmedetomidine & Magnesium Sulphate on Patients Undergoing DHSStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shehab Fathy Ahmed Osman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326397
- Sponsor's protocol ID
- Intrathecal Mgso4& Dex. In DHS
- Status last verified
- Oct 2025
- First submitted
- 19 Nov 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Evaluation of Intrathecal Dexmedetomidine and Magnesium Sulphate as Adjuvants to 0.5% Hyperbaric Bupivacaine for Spinal Anesthesia in Patients Undergoing Dynamic Hip Screw (DHS) Fixation: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT07326397
- Acronym / sponsor ID
- Intrathecal Mgso4& Dex. In DHS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Dec 2027 (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.
To compare the efficacy and safety of intrathecal dexmedetomidine and magnesium sulphate as adjuvants to 0.5% hyperbaric bupivacaine in patients undergoing elective DHS fixation, focusing on onset and duration of sensory and motor block, hemodynamic stability, and quality of postoperative analgesia.
Detailed description
Spinal anesthesia is a preferred technique for lower limb orthopedic surgeries due to its rapid onset, reliable sensory and motor blockade, and minimal systemic side effects. Hyperbaric bupivacaine 0.5% is commonly used; however, its duration may be insufficient for prolonged procedures or postoperative analgesia. To enhance and prolong anesthesia and analgesia, various intrathecal adjuvants have been investigated.
Dexmedetomidine, a selective α2-adrenergic agonist, has shown promise in improving the quality and duration of spinal anesthesia by providing prolonged sensory and motor blockade, stable hemodynamics, and enhanced postoperative analgesia. Similarly, magnesium sulphate, an NMDA receptor antagonist, exerts antinociceptive effects by modulating calcium influx in nerve cells, potentially prolonging analgesia without significant motor blockade.
Dynamic hip screw (DHS) fixation is a common surgical intervention for intertrochanteric femur fractures, particularly in elderly patients. These procedures demand reliable intraoperative anesthesia and effective postoperative pain control to facilitate early mobilization and reduce complications.
Despite individual studies evaluating these agents, direct comparisons between intrathecal dexmedetomidine and magnesium sulphate as adjuvants to bupivacaine in DHS fixation remain limited. This study aims to compare their efficacy and safety in enhancing spinal anesthesia, thereby optimizing perioperative care in patients undergoing elective DHS fixation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D (Dexmedetomidine) | Active comparator | Drug: Dexmedetomidine |
| Group M (Magnesium Sulphate) | Active comparator | Drug: Magnesium Sulphate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-65 year
- ASA Physical Status I or II
- Scheduled for elective DHS fixation under spinal anesthesia
- Written informed consent provided
- Patients of both sex are included in the study.
Key exclusion criteria (6 listed)
- Patient refusal
- Allergy to study drugs
- Local infection at injection site
- Neurological or psychiatric illness
- Coagulopathy
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 |
|---|---|---|
| Dexmedetomidine2.5 mL 0.5% hyperbaric bupivacaine + 5 µg dexmedetomidine (0.5 mL), total volume 3 mL | Drug | Group D (Dexmedetomidine) |
| Magnesium Sulphate2.5 mL 0.5% hyperbaric bupivacaine + 50 mg magnesium sulphate (0.5 mL), total volume 3 mL | Drug | Group M (Magnesium Sulphate) |
Primary outcome
Highest Dermatome Level of Sensory Block
Time frame: 24 hours after intervention
Sensory block level assessed using a pinprick test and recorded as the highest dermatome level with loss of sensation.
Duration of postoperative analgesia
Time frame: 24 hours after intervention
The outcome is Measured by Vas Score to assess pain intensity. It consists of a numeric version of the visual analogue scale. It is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible. This scale can be administered verbally. Vas score for 24 h will be assessed at 0., 1, 12 and 24 h postoperatively and will be recorded.
Degree of Motor Block
Time frame: 24 hours after intervention
Motor block assessed using the Modified Bromage Scale (0-3), where higher scores indicate greater motor block.
4 secondary outcomes
Heart Rate
Time frame: 24 hours after intervention
Incidence of Adverse Effects
Time frame: 24 hours after Intervention
Mean Arterial Pressure
Time frame: 24 hours after intervention
Oxygen Saturation
Time frame: 24 hours after intervention
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.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine and Magnesium Sulphate in people with Effects of Dexmedetomidine & Magnesium Sulphate on Patients Undergoing DHS, run by Assiut 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 5 inclusion and 6 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.
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?
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?
Highest Dermatome Level of Sensory Block (time frame: 24 hours after intervention). The study lists 3 primary outcomes in all. 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; AzTrials last refreshed its copy on 7 Nov 2026.