dexmedetomidine 3mcg group
Drug3mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline.
NCT Number: NCT06942000
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
Trial opening soon.
Get Notified20 year–40 year
Female
Interventional
Phase 3
Faculty of Medicine, Al-Azhar University, Assiut, Egypt, Asyut, Egypt
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline.
5mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline.
(0.5 ml) preservative-free 0.9% saline
Time frame: Shivering will be measured at the following time points: (Immediately after spinal anesthesia, and at 5, 10, 15, 20, 30, 40, 50, 60 and 90 minutes later
evaluate the effect of intrathecal dexmedetomidine, administered as an adjunct to hyperbaric bupivacaine for Cesarean delivery, on the incidence and severity of shivering associated with spinal anesthesia.
Time frame: Immediately after spinal anesthesia, and within 90 minutes later
the incidence of adverse effects, including nausea, vomiting, bradycardia, hypotension and sedation.
Contact information is provided by the study sponsor or research team.
Al-Azhar University
Other
Efficacy of Dexmedetomidine as Adjuvant to Intrathecal Bupivacaine in Decreasing Incidence of Post-spinal Shivering in Pregnant Women Undergoing Cesarean Section.
Acronym: DEX
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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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