DexmedetomidinePhase 4NCT07395271
Comparing Doses of Intrathecal Dexmedetomidine
A Phase 4 study testing Dexmedetomidine 5 mcg and Dexmedetomidine 10 mcg in people with Dexmedetomidine, run by Bahria International Hospital at 1 site in Pakistan.
Trial summary
To compare the duration of sensory and motor blockade produced by two different intrathecal doses of dexmedetomidine (5 µg and 10 µg) when added to hyperbaric bupivacaine in patients undergoing elective cesarean section Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Dexmedetomidine
- What is being tested?
- Dexmedetomidine 5 mcg and Dexmedetomidine 10 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Oct 2025to 21 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Parturients aged 20-40 years
- ASA physical status II
- Scheduled for elective cesarean section
- Ability to provide informed written consent
Who cannot join
- ASA physical status III or higher
- Emergency cesarean section
- Previous labor analgesia
- History of cardiovascular, neurological, or systemic disease
- Contraindications to spinal anesthesia
- Surgery duration exceeding 60 minutes
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Bahria International Hospital
Rawalpindi, Punjab Province, 46220
About this study
Official title: Comparing Doses of Intrathecal Dexmedetomidine Along With Bupivacaine for Cesarean Section: A Double-Blind Randomized Clinical Trial
To compare the duration of sensory and motor blockade produced by two different intrathecal doses of dexmedetomidine (5 µg and 10 µg) when added to hyperbaric bupivacaine in patients undergoing elective cesarean section
Read the detailed description
Cesarean section remains one of the most commonly performed surgical procedures worldwide, serving as a critical intervention to reduce maternal and neonatal morbidity when vaginal delivery poses increased risks. Global cesarean delivery rates have risen steadily, from approximately 7% in 1990 to around 21% in recent years, with projections indicating that by 2030, nearly one in three births may occur via cesarean section .This trend is particularly pronounced in regions like Latin America and the Caribbean (over 40%) and varies significantly by socioeconomic factors, healthcare access, and clinical indications . In Pakistan and similar settings, rates continue to increase, underscoring the need for optimized anesthetic techniques that prioritize maternal safety, fetal well-being, rapid recovery, and effective postoperative pain control.
Regional anesthesia, specifically spinal anesthesia, is the preferred method for elective cesarean sections due to its rapid onset, avoidance of airway complications associated with general anesthesia, minimal placental transfer of drugs, and enhanced maternal satisfaction. Hyperbaric bupivacaine is the most widely used local anesthetic for this purpose, providing reliable sensory and motor blockade. However, when used alone, bupivacaine offers relatively short-duration postoperative analgesia, which can delay ambulation, hinder early mother-infant bonding, and increase the need for systemic analgesics6. To address these limitations, various intrathecal adjuvants have been investigated to enhance block quality, prolong analgesia, and improve overall outcomes.
Dexmedetomidine, a highly selective α2-adrenergic agonist, exhibits sedative, anxiolytic, and analgesic properties without significant respiratory depression. When administered intrathecally, it inhibits nociceptive transmission through presynaptic C-fibers and postsynaptic dorsal horn neurons, resulting in prolonged sensory and motor blockade compared to bupivacaine alone8,9 . Multiple recent studies and meta-analyses have confirmed its efficacy as an adjuvant in obstetric spinal anesthesia, demonstrating extended analgesia duration, reduced shivering, and fewer side effects (e.g., pruritus, nausea) than opioids like fentanyl . However, the optimal intrathecal dose remains controversial: lower doses (e.g., 3-5 µg) may offer a favorable benefit-risk profile with minimal hemodynamic impact, while higher doses (e.g., 10 µg) provide greater prolongation but raise concerns about potential bradycardia or hypotension in parturient.
This prospective, double-blind, randomized clinical trial compares the effects of two commonly used doses of intrathecal dexmedetomidine-5 µg and 10 µg-when added to a standard dose of hyperbaric bupivacaine (12.5 mg) for elective cesarean section. The primary aim is to determine which dose yields superior prolongation of sensory and motor blockade while maintaining maternal hemodynamic stability and safety.
- Conditions
- Dexmedetomidine
- Being tested
- Dexmedetomidine 5 mcg, Dexmedetomidine 10 mcg
- Keywords
- Dexmedetomidine, spinal anesthesia, cesarean section, bupivacaine, sensory block, motor block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine 5 mcgDrug
Also called Dexmedetomidine 5mcg
12.5 mg (2.5 mL) of 0.5% hyperbaric bupivacaine + 5 µg dexmedetomidine
Dexmedetomidine 10 mcgDrug
Also called Dexmedetomidine 10mcg
12.5 mg (2.5 mL) of 0.5% hyperbaric bupivacaine + 10 µg dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Dexmedetomidine 5 mcg Receives: Drug: Dexmedetomidine 5 mcg |
| Group B | Active comparator | Dexmedetomidine 10 mcg Receives: Drug: Dexmedetomidine 10 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of sensory blockade
Visual Analouge Scale (0 to 10)
Measured: 6 hrs
Duration of motor blockade
Bromage Scale (1 to 5)
Measured: 6 hrs
Secondary outcomes (2)
Hemodynamic parameters
Heart rate per minute
Measured: Till end of surgery
Hemodynamic parameters
Mean arterial pressure in millimeters of mercury
Measured: Till end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start22 Oct 2025
- Primary completion21 Jan 2026
- Study completion21 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahria International Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azher Munir, Bahria International Hospital
- Investigators
- azher munir, mbbs, Principal investigator, Bahria International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395271
- Sponsor's protocol ID
- 2021-6907
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mowar A, Singh V, Pahade A, Karki G. Effect of three different doses of intrathecal dexmedetomidine on subarachnoid block: a prospective randomized double-blind trial. Anaesth. pain intensive care 2021;26(1):8-13; DOI:10.35975/apic.v26i1.1759
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Doses of Intrathecal Dexmedetomidine Along With Bupivacaine for Cesarean Section: A Double-Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07395271
- Acronym / sponsor ID
- 2021-6907
- Conditions
- Dexmedetomidine
- Keywords
- Dexmedetomidine, spinal anesthesia, cesarean section, bupivacaine, sensory block, motor block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bahria International HospitalUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 21 Jan 2026 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 9 Feb 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 duration of sensory and motor blockade produced by two different intrathecal doses of dexmedetomidine (5 µg and 10 µg) when added to hyperbaric bupivacaine in patients undergoing elective cesarean section
Detailed description
Cesarean section remains one of the most commonly performed surgical procedures worldwide, serving as a critical intervention to reduce maternal and neonatal morbidity when vaginal delivery poses increased risks. Global cesarean delivery rates have risen steadily, from approximately 7% in 1990 to around 21% in recent years, with projections indicating that by 2030, nearly one in three births may occur via cesarean section .This trend is particularly pronounced in regions like Latin America and the Caribbean (over 40%) and varies significantly by socioeconomic factors, healthcare access, and clinical indications . In Pakistan and similar settings, rates continue to increase, underscoring the need for optimized anesthetic techniques that prioritize maternal safety, fetal well-being, rapid recovery, and effective postoperative pain control.
Regional anesthesia, specifically spinal anesthesia, is the preferred method for elective cesarean sections due to its rapid onset, avoidance of airway complications associated with general anesthesia, minimal placental transfer of drugs, and enhanced maternal satisfaction. Hyperbaric bupivacaine is the most widely used local anesthetic for this purpose, providing reliable sensory and motor blockade. However, when used alone, bupivacaine offers relatively short-duration postoperative analgesia, which can delay ambulation, hinder early mother-infant bonding, and increase the need for systemic analgesics6. To address these limitations, various intrathecal adjuvants have been investigated to enhance block quality, prolong analgesia, and improve overall outcomes.
Dexmedetomidine, a highly selective α2-adrenergic agonist, exhibits sedative, anxiolytic, and analgesic properties without significant respiratory depression. When administered intrathecally, it inhibits nociceptive transmission through presynaptic C-fibers and postsynaptic dorsal horn neurons, resulting in prolonged sensory and motor blockade compared to bupivacaine alone8,9 . Multiple recent studies and meta-analyses have confirmed its efficacy as an adjuvant in obstetric spinal anesthesia, demonstrating extended analgesia duration, reduced shivering, and fewer side effects (e.g., pruritus, nausea) than opioids like fentanyl . However, the optimal intrathecal dose remains controversial: lower doses (e.g., 3-5 µg) may offer a favorable benefit-risk profile with minimal hemodynamic impact, while higher doses (e.g., 10 µg) provide greater prolongation but raise concerns about potential bradycardia or hypotension in parturient.
This prospective, double-blind, randomized clinical trial compares the effects of two commonly used doses of intrathecal dexmedetomidine-5 µg and 10 µg-when added to a standard dose of hyperbaric bupivacaine (12.5 mg) for elective cesarean section. The primary aim is to determine which dose yields superior prolongation of sensory and motor blockade while maintaining maternal hemodynamic stability and safety.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Dexmedetomidine 5 mcgDexmedetomidine 5 mcg |
| Group B | Active comparator | Drug: Dexmedetomidine 10 mcgDexmedetomidine 10 mcg |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Parturients aged 20-40 years
- ASA physical status II
- Scheduled for elective cesarean section
- Ability to provide informed written consent
Key exclusion criteria (6 listed)
- ASA physical status III or higher
- Emergency cesarean section
- Previous labor analgesia
- History of cardiovascular, neurological, or systemic disease
- Contraindications to spinal 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 |
|---|---|---|
| Dexmedetomidine 5 mcgAlso: Dexmedetomidine 5mcg12.5 mg (2.5 mL) of 0.5% hyperbaric bupivacaine + 5 µg dexmedetomidine | Drug | Group A |
| Dexmedetomidine 10 mcgAlso: Dexmedetomidine 10mcg12.5 mg (2.5 mL) of 0.5% hyperbaric bupivacaine + 10 µg dexmedetomidine | Drug | Group B |
Primary outcome
Duration of sensory blockade
Time frame: 6 hrs
Visual Analouge Scale (0 to 10)
Duration of motor blockade
Time frame: 6 hrs
Bromage Scale (1 to 5)
2 secondary outcomes
Hemodynamic parameters
Time frame: Till end of surgery
Hemodynamic parameters
Time frame: Till end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publicationMowar A, Singh V, Pahade A, Karki G. Effect of three different doses of intrathecal dexmedetomidine on subarachnoid block: a prospective randomized double-blind trial. Anaesth. pain intensive care 2021;26(1):8-13; DOI:10.35975/apic.v26i1.1759
- Individual participant dataSharing planned: No
Related trials for Dexmedetomidine
Not yet recruitingPhase 4
Intranasal Dexmedetomidine-esketamine Combination and Postoperative Cognitive Recovery in Older Patients
Older Patients, Noncardiac Surgery
Recruiting
Perioperative Dexmedetomidine and Long-term Survival After Cancer Surgery
Elderly, Cancer Surgery
RecruitingPhase 4
Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
Cesarean Delivery, Cesarean Delivery; Neuraxial Opioids
Recruiting
The Impact of a Dexmedetomidine Perfusion on Intraoperative Remifentanil Consumption
Dexmedetomidine, Total Intravenous Anesthesia
RecruitingObservational study
Dexmedetomidine for Refractory Pain in Palliative Cancer Patients
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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. This study is not recruiting at the moment.
azher munir, mbbs principal investigator
Bahria International Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine 5 mcg and Dexmedetomidine 10 mcg in people with Dexmedetomidine, run by Bahria 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 4 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: finished, as of the sponsor's last update on 9 Feb 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Duration of sensory blockade (time frame: 6 hrs). The study lists 2 primary outcomes in all. 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 NCT07395271, which also lists 1 linked publication.
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 9 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.