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NCT Number: NCT07395271

Comparing Doses of Intrathecal Dexmedetomidine

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

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Key information

Conditions

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Bahria International Hospital

Rawalpindi, Punjab Province, 46220, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Parturients aged 20-40 years
  • ASA physical status II
  • Scheduled for elective cesarean section
  • Ability to provide informed written consent

Exclusion criteria

  • 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

Treatment and study plan

Dexmedetomidine 5 mcg

Drug

12.5 mg (2.5 mL) of 0.5% hyperbaric bupivacaine + 5 µg dexmedetomidine

Other names: Dexmedetomidine 5mcg

Dexmedetomidine 10 mcg

Drug

12.5 mg (2.5 mL) of 0.5% hyperbaric bupivacaine + 10 µg dexmedetomidine

Other names: Dexmedetomidine 10mcg

Primary outcomes

  1. Duration of sensory blockade

    Time frame: 6 hrs

    Visual Analouge Scale (0 to 10)

  2. Duration of motor blockade

    Time frame: 6 hrs

    Bromage Scale (1 to 5)

Secondary outcomes

  1. Hemodynamic parameters

    Time frame: Till end of surgery

    Heart rate per minute

  2. Hemodynamic parameters

    Time frame: Till end of surgery

    Mean arterial pressure in millimeters of mercury

Sponsors and collaborators

Lead sponsor

Bahria International Hospital

Other

Registry information

Official study title

Comparing Doses of Intrathecal Dexmedetomidine Along With Bupivacaine for Cesarean Section: A Double-Blind Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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