Intrathecal DexmedetomidinePhase 1/2NCT07807020
This Study Aims to Determine Whether Lower Doses (4 µg) of Intrathecal Dexmedetomidine Can Provide Comparable Analgesic Benefits While Minimizing Adverse Hemodynamic Effects in Patients Encountered in Our Setup( Shifa International Hospital Islamabad).
A Phase 1/2 study testing Intrathecal Dexmedetomidine in people with Intrathecal Dexmedetomidine, run by Shifa International Hospital at 1 site in Pakistan.
Trial summary
This study aims to determine whether lower doses (4 µg) of intrathecal dexmedetomidine can provide comparable analgesic benefits while minimizing adverse hemodynamic effects in patients encountered in our setup( Shifa International Hospital Islamabad). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrathecal Dexmedetomidine
- What is being tested?
- Intrathecal Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 4 May 2026to 4 May 2027
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Classified as ASA physical status II-III
- Scheduled for elective lower limb joint replacement surgeries ( total knee replacement [TKR]) - Written informed consent
Who cannot join
- Allergy to study drugs
- Contraindications to spinal anesthesia
- History of cardiac conduction abnormalities or severe bradycardia
- Neurological or psychiatric illness
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Shifa International Hospital Islamabad
Islamabad, Federal, 44000
About this study
Official title: "Effect of Adding Low-dose Intrathecal Dexmedetomidine to Hyperbaric Bupivacaine on the Duration and Quality of Spinal Anesthesia in Knee Arthroplasty."
This study aims to determine whether lower doses (4 µg) of intrathecal dexmedetomidine can provide comparable analgesic benefits while minimizing adverse hemodynamic effects in patients encountered in our setup( Shifa International Hospital Islamabad). Studies conducted earlier in other setups have used hyperbaric 0.5% bupivacaine but this study will use 0.75% bupivacaine.
Read the detailed description
"Effect of adding low-dose intrathecal dexmedetomidine to hyperbaric bupivacaine on the duration and quality of spinal anesthesia in knee arthroplasty." This study aims to determine whether lower doses (4 µg) of intrathecal dexmedetomidine can provide comparable analgesic benefits while minimizing adverse hemodynamic effects in patients encountered in our setup( Shifa International Hospital Islamabad). Studies conducted earlier in other setups have used hyperbaric 0.5% bupivacaine but this study will use 0.75% bupivacaine.
Objectives Primary Objective To compare the time to first postoperative analgesia request between patients receiving intrathecal 0.75% hyperbaric bupivacaine alone and those receiving intrathecal dexmedetomidine as an adjunct.
Secondary Objectives
- To compare the duration of sensory block between two groups.
- To compare the duration of motor block between two groups.
- To evaluate intraoperative and postoperative hemodynamic stability ( Heart rate and Mean Arterial Pressures).
- To determine the incidence of adverse effects (bradycardia, hypotension, nausea, sedation) in both groups.
Methodology Study design Quasi-experimental, non-randomized controlled design Study setting
- Department of anesthesia, Shifa International Hospital Ltd. Study duration
- 12 Months Sample Size and Study Groups Total 60 patients (30 per group) based on power analysis.
Group A: 1.5 mL of 0.75% hyperbaric bupivacaine + 4 µg dexmedetomidine + Normal Saline to make total volume 2.0 mL Group B (Control): 1.5 mL of 0.75% hyperbaric bupivacaine + 0.5 mL Normal Saline to make total volume 2.0 mL Inclusion Criteria
- Patients aged between 18 and 60 years
- Classified as ASA physical status II-III
- Scheduled for elective lower limb joint replacement surgeries ( total knee replacement [TKR])
- Written informed consent Exclusion Criteria
- Allergy to study drugs
- Contraindications to spinal anesthesia
- History of cardiac conduction abnormalities or severe bradycardia
- Neurological or psychiatric illness
- Pregnancy or lactation
Grouping Method A total of 60 participants will be included in the study. Participants will be allocated into intervention and comparison groups based on the treating physician's clinical judgement.. Group I (intervention group) will consist of participants who will receive dexmedetomidine, while Group II (comparison group) will consist of participants who will not receive the dexmedetomidine.
Drug Preparation and Administration Dexmedetomidine (100 µg/mL) will be drawn using an insulin syringe for accuracy and will be added in 9 ml Normal Saline (Total 10 ml) to make a concentration of 10 µg/mL.
For 4 µg: 0.4 mL dexmedetomidine (10 µg/mL) diluted with normal saline to make 0.5 mL will be prepared in an insulin syringe.
The control group will receive 0.5 mL saline in an insulin syringe. All solutions will be clear and identical, prepared immediately before injection. Each patient will receive a total of 2.0 mL intrathecally at L3-L4 or L4-L5 using a 25G Quincke needle.
Outcome Measures
Primary Outcome:
- Time from spinal injection to first postoperative analgesic request.
Secondary Outcomes:
- Total analgesic consumption in 24 hours
- The duration of the sensory and motor block and how they gradually wear off over time
- Hemodynamic parameters (HR, MAP)
- Sedation score (Ramsay Sedation Scale).
- Incidence of adverse events (bradycardia, hypotension, nausea, shivering)
Timeline Total duration: 12 months ( 8 months data collection, 2 months analysis, 2 months reporting).
- Conditions
- Intrathecal Dexmedetomidine
- Being tested
- Intrathecal Dexmedetomidine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal DexmedetomidineDrug
Also called precidex
Group A experimental group: 1.5 mL of 0.75% hyperbaric bupivacaine + 4 µg dexmedetomidine + Normal Saline to make total volume 2.0 mLThis study aims to determine whether lower doses (4 µg) of intrathecal dexmedetomidine can provide comparable analgesic benefits while minimizing adverse hemodynamic effects in patients encountered in our setup( Shifa International Hospital Islamabad). Studies conducted earlier in other setups have used hyperbaric 0.5% bupivacaine but this study will use 0.75% bupivacaine
PlaceboOther
Group B (Control): 1.5 mL of 0.75% hyperbaric bupivacaine + 0.5 mL Normal Saline to make total volume 2.0 mL
| Study group | Role | What they receive |
|---|---|---|
| Group A: Interventional group recieving intrathecal dexmedetomidine and bupivicaine + saline | Experimental | 1.5 mL of 0.75% hyperbaric bupivacaine + 4 µg dexmedetomidine + Normal Saline to make total Receives: Drug: Intrathecal Dexmedetomidine |
| Group B (Control): 1.5 mL of 0.75% hyperbaric bupivacaine + 0.5 mL Normal Saline to make total volum | Placebo comparator | no dexmedetomidine will be given in this group instead normal saline with hyperbaric bupivicaine will be used intrathecally to make total volume of 2ml. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from spinal injection to first postoperative analgesic request
This will indicate the difference in duration of analgesic effect of bupivacaine + dexmedetomidine group vs group receiving bupivacaine only
Measured: Total analgesic consumption in 24 hours
Secondary outcomes (1)
Secondary Outcome Measure
Measured: Total analgesic consumption in 24 hours - The duration of the sensory and motor block and how they gradually wear off over time - Hemodynamic parameters (HR, MAP) - Sedation score (Ramsay Sedation Scale). - Incidence of adverse events bradycardia,hypoten
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start4 May 2026
- Primary completion4 May 2027 (estimated)
- Study completion4 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intrathecal DexmedetomidineStudies 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 1/2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shifa International Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasir Sultan, Shifa International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807020
- Sponsor's protocol ID
- ShifaH
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It can be shared while keeping the individual participant identity anonymous.
Publications
Anaesth Pain Intensive Care. Cochrane Central Register of Controlled Trials and sourced from Embase. 2019;23(2):198-203
Ioannidis R, Zapantis-Gakis C, Zarogianni T, Manouskou N, Sarridou D. Dexmedetomidine in Spinal Anesthesia for Orthopedic Surgery: Extending Analgesia Beyond the Operating Room. Cureus. 2025 Oct 22;17(10):e95136. doi: 10.7759/cureus.95136. eCollection 2025 Oct.
PubMed 41281055. Eur J Mol Clin Med. Cochrane Central Register of Controlled Trials and sourced from Embase2022;9(7):2179-2186.
Ann Pak Inst Med Sci. 2025;21(2):474-8. doi:10.48036/apims.v21i2.1145
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effect of Adding Low-dose Intrathecal Dexmedetomidine to Hyperbaric Bupivacaine on the Duration and Quality of Spinal Anesthesia in Knee Arthroplasty."
- ClinicalTrials.gov ID
- NCT07807020
- Acronym / sponsor ID
- ShifaH
- Conditions
- Intrathecal Dexmedetomidine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shifa International HospitalUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- 4 May 2027 (estimated)
- Study completion
- 4 May 2027 (estimated)
- First posted
- 8 Sep 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.
This study aims to determine whether lower doses (4 µg) of intrathecal dexmedetomidine can provide comparable analgesic benefits while minimizing adverse hemodynamic effects in patients encountered in our setup( Shifa International Hospital Islamabad). Studies conducted earlier in other setups have used hyperbaric 0.5% bupivacaine but this study will use 0.75% bupivacaine.
Detailed description
"Effect of adding low-dose intrathecal dexmedetomidine to hyperbaric bupivacaine on the duration and quality of spinal anesthesia in knee arthroplasty." This study aims to determine whether lower doses (4 µg) of intrathecal dexmedetomidine can provide comparable analgesic benefits while minimizing adverse hemodynamic effects in patients encountered in our setup( Shifa International Hospital Islamabad). Studies conducted earlier in other setups have used hyperbaric 0.5% bupivacaine but this study will use 0.75% bupivacaine.
Objectives Primary Objective To compare the time to first postoperative analgesia request between patients receiving intrathecal 0.75% hyperbaric bupivacaine alone and those receiving intrathecal dexmedetomidine as an adjunct.
Secondary Objectives
- To compare the duration of sensory block between two groups.
- To compare the duration of motor block between two groups.
- To evaluate intraoperative and postoperative hemodynamic stability ( Heart rate and Mean Arterial Pressures).
- To determine the incidence of adverse effects (bradycardia, hypotension, nausea, sedation) in both groups.
Methodology Study design Quasi-experimental, non-randomized controlled design Study setting
- Department of anesthesia, Shifa International Hospital Ltd. Study duration
- 12 Months Sample Size and Study Groups Total 60 patients (30 per group) based on power analysis.
Group A: 1.5 mL of 0.75% hyperbaric bupivacaine + 4 µg dexmedetomidine + Normal Saline to make total volume 2.0 mL Group B (Control): 1.5 mL of 0.75% hyperbaric bupivacaine + 0.5 mL Normal Saline to make total volume 2.0 mL Inclusion Criteria
- Patients aged between 18 and 60 years
- Classified as ASA physical status II-III
- Scheduled for elective lower limb joint replacement surgeries ( total knee replacement [TKR])
- Written informed consent Exclusion Criteria
- Allergy to study drugs
- Contraindications to spinal anesthesia
- History of cardiac conduction abnormalities or severe bradycardia
- Neurological or psychiatric illness
- Pregnancy or lactation
Grouping Method A total of 60 participants will be included in the study. Participants will be allocated into intervention and comparison groups based on the treating physician's clinical judgement.. Group I (intervention group) will consist of participants who will receive dexmedetomidine, while Group II (comparison group) will consist of participants who will not receive the dexmedetomidine.
Drug Preparation and Administration Dexmedetomidine (100 µg/mL) will be drawn using an insulin syringe for accuracy and will be added in 9 ml Normal Saline (Total 10 ml) to make a concentration of 10 µg/mL.
For 4 µg: 0.4 mL dexmedetomidine (10 µg/mL) diluted with normal saline to make 0.5 mL will be prepared in an insulin syringe.
The control group will receive 0.5 mL saline in an insulin syringe. All solutions will be clear and identical, prepared immediately before injection. Each patient will receive a total of 2.0 mL intrathecally at L3-L4 or L4-L5 using a 25G Quincke needle.
Outcome Measures
Primary Outcome:
- Time from spinal injection to first postoperative analgesic request.
Secondary Outcomes:
- Total analgesic consumption in 24 hours
- The duration of the sensory and motor block and how they gradually wear off over time
- Hemodynamic parameters (HR, MAP)
- Sedation score (Ramsay Sedation Scale).
- Incidence of adverse events (bradycardia, hypotension, nausea, shivering)
Timeline Total duration: 12 months ( 8 months data collection, 2 months analysis, 2 months reporting).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Interventional group recieving intrathecal dexmedetomidine and bupivicaine + saline | Experimental | Drug: Intrathecal Dexmedetomidine1.5 mL of 0.75% hyperbaric bupivacaine + 4 µg dexmedetomidine + Normal Saline to make total |
| Group B (Control): 1.5 mL of 0.75% hyperbaric bupivacaine + 0.5 mL Normal Saline to make total volum | Placebo comparator | Other: Placebono dexmedetomidine will be given in this group instead normal saline with hyperbaric bupivicaine will be used intrathecally to make total volume of 2ml. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Classified as ASA physical status II-III
- Scheduled for elective lower limb joint replacement surgeries ( total knee replacement [TKR]) - Written informed consent
Key exclusion criteria (5 listed)
- Allergy to study drugs
- Contraindications to spinal anesthesia
- History of cardiac conduction abnormalities or severe bradycardia
- Neurological or psychiatric illness
- Pregnancy or lactation
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 |
|---|---|---|
| Intrathecal DexmedetomidineAlso: precidexGroup A experimental group: 1.5 mL of 0.75% hyperbaric bupivacaine + 4 µg dexmedetomidine + Normal Saline to make total volume 2.0 mLThis study aims to determine whether lower doses (4 µg) of intrathecal dexmedetomidine can provide comparable analgesic benefits while minimizing adverse hemodynamic effects in patients encountered in our setup( Shifa International Hospital Islamabad). Studies conducted earlier in other setups have used hyperbaric 0.5% bupivacaine but this study will use 0.75% bupivacaine | Drug | Group A: Interventional group recieving intrathecal dexmedetomidine and bupivicaine + saline |
| PlaceboGroup B (Control): 1.5 mL of 0.75% hyperbaric bupivacaine + 0.5 mL Normal Saline to make total volume 2.0 mL | Other | Group B (Control): 1.5 mL of 0.75% hyperbaric bupivacaine + 0.5 mL Normal Saline to make total volum |
Primary outcome
Time from spinal injection to first postoperative analgesic request
Time frame: Total analgesic consumption in 24 hours
This will indicate the difference in duration of analgesic effect of bupivacaine + dexmedetomidine group vs group receiving bupivacaine only
1 secondary outcome
Secondary Outcome Measure
Time frame: Total analgesic consumption in 24 hours - The duration of the sensory and motor block and how they gradually wear off over time - Hemodynamic parameters (HR, MAP) - Sedation score (Ramsay Sedation Scale). - Incidence of adverse events bradycardia,hypoten
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 Sep 2026.
- Results publicationAnaesth Pain Intensive Care. Cochrane Central Register of Controlled Trials and sourced from Embase. 2019;23(2):198-203
- Results publication: PubMed 41281055Ioannidis R, Zapantis-Gakis C, Zarogianni T, Manouskou N, Sarridou D. Dexmedetomidine in Spinal Anesthesia for Orthopedic Surgery: Extending Analgesia Beyond the Operating Room. Cureus. 2025 Oct 22;17(10):e95136. doi: 10.7759/cureus.95136. eCollection 2025 Oct.
- Results publication. Eur J Mol Clin Med. Cochrane Central Register of Controlled Trials and sourced from Embase2022;9(7):2179-2186.
- Results publicationAnn Pak Inst Med Sci. 2025;21(2):474-8. doi:10.48036/apims.v21i2.1145
- The citation 2025; 21(2): 474-8. doi:10.48036/apims.v21i2.1145 refers to an article in the Annals of PIMS - Shaheed Zulfiqar Ali Bhutto Medical University (APIMS) published in Volume 21, Issue 2, 2025.Link provided by the sponsor.
- Cureus Journal of Medical Science's official page for the article identified by 2025;17(10):e95136Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It can be shared while keeping the individual participant identity anonymous.
Related trials for Intrathecal Dexmedetomidine
Active, not recruitingEarly Phase 1
Comparison of Analgesic Efficacy of Intrathecal Bupivacaine Versus Bupivacaine Plus Dexmedetomidine in Patients Undergoing Orthopedic Surgeries.
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Assessing the Time-Course of Dexmedetomidine-Induced Analgesia Via EEG
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Not yet recruitingPhase 2/3
Intrathecal Dexmedetomidine and Postoperative Delirium in Elderly Hip Fracture Surgery
Postoperative Delirium, Hip Fractures
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Ultrasound-Guided Posterior Quadratus Lumborum Block With Bupivacaine and Dexmedetomidine Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery
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Recruiting
Intrathecal Morphine Versus Intrathecal Dexmedetomidine Compared to Placebo for Postoperative Pain Relief After Spine Fixation Surgeries
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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.
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 1/2 study testing Intrathecal Dexmedetomidine in people with Intrathecal Dexmedetomidine, run by Shifa International Hospital 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 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: enrolling by invitation, as of the sponsor's last update on 8 Sep 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Time from spinal injection to first postoperative analgesic request (time frame: Total analgesic consumption in 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07807020, which also lists 4 linked publications.
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 Sep 2026.