NCT06942000

Intrathecal DEX With Bupivacaine Inpost-spinal Shivering After CS.

Efficacy of Dexmedetomidine as Adjuvant to Intrathecal Bupivacaine in Decreasing Incidence of Post-spinal Shivering in Pregnant Women Undergoing Cesarean Section.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized, double-blind, placebo-controlled study to determine whether intrathecal dexmedetomidine, administered along with hyperbaric bupivacaine for covering Cesarean delivery decreases the incidence of shivering associated with spinal anesthesia

Detailed description

The study will be carried out at AL Azhar University Hospitals (Assiut) on 120 parturients belonging to ASA physical status I and II undergoing an elective cesarean delivery under spinal anesthesia procedure. Sample size was determined by department of statistics of faculty of medicine, Al-Azhar university (Assiut). Randomization, blinding and allocation concealment parturients will be randomly assigned into three equal groups (40 parturients for each group). According to the random number generated by computer, parturient were randomly allocated into three equal groups (40 parturients for each group) to receive either dexmedetomidine 3mcg, dexmedetomidine 5mcg or normal saline in combination with bupivacaine. The randomization sequence was placed in serially numbered opaque envelopes. Before the start of spinal anesthesia, an anesthesiologist who would not involve in the study will prepare relevant drugs according to the randomization sequence

Conditions

• Post Spinal Anesthesia Shivering

Interventions

Type	Name	Description
DRUG	dexmedetomidine 3mcg group	3mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline.
DRUG	dexmedetomidine 5mcg	5mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline.
DRUG	preservative-free 0.9% saline.	(0.5 ml) preservative-free 0.9% saline

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-11-30
• Completion: 2025-12-30
• First posted: 2025-04-24
• Last updated: 2025-04-24

Locations

2 sites across 1 country: Egypt