Clinical trial NCT06942000: Intrathecal DEX With Bupivacaine Inpost-spinal Shivering After CS.
Official title: Efficacy of Dexmedetomidine as Adjuvant to Intrathecal Bupivacaine in Decreasing Incidence of Post-spinal Shivering in Pregnant Women Undergoing Cesarean Section.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Post Spinal Anesthesia Shivering
Keywords: Cesarean Section
Dexmedetomidine
Intrathecal Anesthesia
Shivering
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

Brief 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

Eligibility criteria: Inclusion Criteria:

* Full-term pregnant women undergoing elective cesarean section under spinal anesthesia.
* singleton pregnancy
* Age: 20 \~ 40 years;
* ASA physical status II \~ III;

Exclusion Criteria:

* parturient less than 20 years and more than 40 years.
* History of uncontrolled comorbidities, cardiac (e.g., pre-eclampsia and hypertension), respiratory, renal or hepatic disease.
* parturients who had allergy to any medication in the study.
* parturients with contraindications to spinal anesthesia (coagulation disorder, infection at site of puncture, raised intracranial tension or any spine deformity)
* parturient who has history of alcohol intake.
* parturient received any medication likely to affect thermoregulation or Veno dilation.
* Refusing to sign informed consent.

Primary outcomes:
measure: efficacy on the incidence and severity of shivering associated with spinal anesthesia.
timeFrame: 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
Secondary outcomes:
measure: incidence of adverse effects
timeFrame: Immediately after spinal anesthesia, and within 90 minutes later
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine, Al-Azhar University, Assiut, Egypt
city: Assiut
country: Egypt
facility: Mohamed Ali Mahmoud
Study officials:
affiliation: Professor at Faculty of Medicine, Al-Azhar University, Assiut, Egypt
name: Osama H. Ahmed, MD
role: STUDY_DIRECTOR
References: