Intravenous Dexmedetomidine in Cesarean Section Under Spinal Anesthesia

Study Overview
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Brief Summary
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The present study hypothesized that intravenous dexmedetomidine use during spinal anesthesia for cesarean section has a beneficial influence on hemodynamic stability and epigastric pain together with satisfactory analgesic effects and excellent safety profile for the mother and the newborn.

Detailed Description
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Background and aim: Hypotension and epigastric pain are commonly encountered during spinal anesthesia for cesarean section. Dexmedetomidine (DEX) is a highly selective α 2-adrenergic agonist. Its effects entail sympatholytic, sedative, anesthetic, and analgesic actions. The present randomized study aimed to evaluate the effect of intravenous DEX administration on the hemodynamic parameters and epigastric pain in women subjected to cesarean section. Patients and Methods: This study is a randomized double-blinded controlled trial. Seventy patients were randomly assigned to one of two interventional groups: one group received spinal anesthesia and intravenous DEX (1µg/kg) and the other group received spinal anesthesia and placebo (saline). The administrated drugs were slowly injected intravenously over 10 minutes then intrathecal block was achieved using 2-2.2 ml of hyperbaric bupivacaine (10 -12.5 mg) introduced at L3/4 or L4/5 interspace. Primary Outcome parameters included frequency of hypotension episodes, frequency of ephedrine doses needed, sedation score and epigastric pain episodes. Secondary outcomes included time to onset of sensory and motor blocks, duration of sensory and motor blocks, operative duration, time needed to request of rescue analgesia, level of intrathecal block, and neonatal Apgar score at 1 and 5 minutes.

Official Title
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Intravenous Dexmedetomidine Reduces Hypotension and Epigastric Pain in Cesarean Section Under Spinal Anesthesia: A Randomized Clinical Study

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Drug: Dexmedetomidine Injectable Product
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full-term pregnancy and American Society of Anesthesiologists (ASA) physical status I/II in women scheduled for elective cesarean section Exclusion Criteria: Severe hepatic or renal disease Severe cardiopulmonary disease Thyroid disorders multiple allergies prematurity Known fatal abnormality Known chronic gastrointestinal problems with epigastric pain e.g. peptic ulcer and reflux esophagitis.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br>spinal anesthesia and intravenous dexmedetomidine(1µg/kg) | Drug: Dexmedetomidine Injectable Product<br>* Spinal anesthesia and intravenous dexmedetomidine (1μg/kg). The administrated drugs were slowly injected intravenously over 10 minutes then intrathecal block was achieved using 2-2.2 ml of hyperbaric bupivacaine (10 -12.5 mg) introduced at L3/4 or L4/5 interspace.<br>* Other names: Precedex;|
| Placebo Comparator: Saline<br>spinal anesthesia and placebo (saline). | Drug: Saline<br>* Spinal anesthesia and intravenous saline. The administrated drugs were slowly injected intravenously over 10 minutes then intrathecal block was achieved using 2-2.2 ml of hyperbaric bupivacaine (10 -12.5 mg) introduced at L3/4 or L4/5 interspace.<br>* Other names: saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypotension | systolic blood pressure < 90 mmHg | up to 48 hours postoperative | 
| ephedrine use | frequency of ephedrine doses needed | up to 48 hours postoperative | 
| sedation | sedation score | up to 48 hours postoperative | 
| epigastric pain | Pain in the epigastric region assessed by Visual Analog Scale | up to 48 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensory and motor blocks | time to onset of sensory and motor blocks | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexmedetomidine, spinal anesthesia, cesarean section, epigastric pain