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Efficacy of Dexmedetomidine as Adjuvant to Intrathecal Bupivacaine in Decreasing Incidence of Post-spinal Shivering in Pregnant Women Undergoing Cesarean Section.
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
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
Age
20 - 40 years
Sex
FEMALE
Healthy Volunteers
No
Faculty of Medicine, Al-Azhar University, Assiut, Egypt
Asyut, Egypt
Mohamed Ali Mahmoud
Asyut, Egypt
Start Date
May 1, 2025
Primary Completion Date
November 30, 2025
Completion Date
December 30, 2025
Last Updated
April 24, 2025
40
ESTIMATED participants
dexmedetomidine 3mcg group
DRUG
dexmedetomidine 5mcg
DRUG
preservative-free 0.9% saline.
DRUG
Lead Sponsor
Al-Azhar University
Data Source & Attribution
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