Intrathecal DEX With Bupivacaine Inpost-spinal Shivering After CS.

ConditionPost Spinal Anesthesia Shivering

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexFemale

Age20-40

SponsorAl-Azhar University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Full-term pregnant women undergoing elective cesarean section under spinal anesthesia.

singleton pregnancy

Age: 20 ~ 40 years;

ASA physical status II ~ III;

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

dexmedetomidine 3mcg group
Drug
3mcg of preservative-free dexmedetomidine in (0.5 ml) preservative-free 0.9% saline.
dexmedetomidine 5mcg
Drug
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

Treatment groups

40 Participants

are divided into 3 treatment groups

Group A: Group D3: (dexmedetomidine 3mcg group)Active comparator 1 intervention

Group B: Group D5: (dexmedetomidine 5mcg group)Active comparator 1 intervention

Group C: Group C: (Control group)Placebo comparator 1 intervention

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Al-Azhar University

Lead sponsor

Source ClinicalTrials.gov

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