Intrathecal DEX With Bupivacaine Inpost-spinal Shivering After CS.

Phase 3Not Yet RecruitingNCT06942000

Al-Azhar University40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Post Spinal Anesthesia Shivering

Interventions

dexmedetomidine 3mcg groupDRUG

3mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline.

dexmedetomidine 5mcgDRUG

5mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline.

preservative-free 0.9% saline.DRUG

(0.5 ml) preservative-free 0.9% saline

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (2)

Faculty of Medicine, Al-Azhar University, Assiut, Egypt

Asyut, Egypt

Mohamed Ali Mahmoud

Asyut, Egypt

Outcomes

Primary Outcomes

efficacy on the incidence and severity of shivering associated with spinal anesthesia.

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: 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

incidence of adverse effects

the incidence of adverse effects, including nausea, vomiting, bradycardia, hypotension and sedation.

Time frame: Immediately after spinal anesthesia, and within 90 minutes later

Central Contacts

Mohamed A. Mahmoud, MD

CONTACT

01002538320 mohamedali.226@azhar.edu.eg

Data from ClinicalTrials.gov

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