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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Pakistan

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 groups in NCT07395271
Study groupRoleWhat they receive
Group AActive comparatorDexmedetomidine 5 mcg
Receives: Drug: Dexmedetomidine 5 mcg
Group BActive comparatorDexmedetomidine 10 mcg
Receives: Drug: Dexmedetomidine 10 mcg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of sensory blockade

    Visual Analouge Scale (0 to 10)

    Measured: 6 hrs

  2. Duration of motor blockade

    Bromage Scale (1 to 5)

    Measured: 6 hrs

Secondary outcomes (2)
  1. Hemodynamic parameters

    Heart rate per minute

    Measured: Till end of surgery

  2. 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.

  1. First posted9 Feb 2026
  2. Study start22 Oct 2025
  3. Primary completion21 Jan 2026
  4. Study completion21 Jan 2026

Resources

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)
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

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.

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