Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effectiveness of low dose scheme with dexmedetomidine as an adjuvant. Taking in consideration optimum intraoperative surgical conditions, best post-operative pain free experience, and more stable hemodynamic.

Official Title
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Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section: Randomized Controlled Trial

Conditions
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Cesarean Section, Spinal Anesthesia, Dexmedetomidine

Intervention / Treatment
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* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full-term pregnant women Singleton gestation American Society of Anaesthesiologists (ASA) physical status classes II and I Exclusion Criteria: Preterm pregnancy (<37 wks. gestation) Multiple gestation Cardiovascular disease (e.g., preeclampsia, hypertension) and the use of antihypertensive medications Asthma and allergy to non-steroidal anti-inflammatory drugs Conditions that prevent spinal anaesthesia Failed spinal block and conversion to general anaesthesia A history of established chronic pain Drug addiction A psychiatric disorder Inability to communicate effectively

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LD-DEX<br>This group will receive 7mg hyperbaric bupivacaine (about 1.4 ml of hyperbaric bupivacaine 0.5%) and 10μg dexmedetomidine (10 unit by U-100 insulin syringe using a preservative free dexmedetomidine 100μg/ml). | Drug: Dexmedetomidine<br>* 10μg dexmedetomidine will be added to the injectate to be injected intrathecally<br>* Other names: Precedex;|
| No Intervention: Control group<br>This group will receive 12 mg hyperbaric bupivacaine (about 2.2 ml of hyperbaric bupivacaine 0.5%). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Density of motor and sensory blockade |  | Intraoperative | 
| Haemodynamic stability and total doses of IV fluids and vasopressors |  | Intraoperative | 
| Time to first postoperative rescue analgesic request |  | 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The intraoperative patient and surgeon satisfaction (successful delivery) |  | Intraoperative | 
| The peak sensory level of block |  | Intraoperative | 
| Time from intrathecal injection to peak sensory block level |  | Intraoperative | 
| The time to two sensory block segment regression |  | Intraoperative and 24 hour | 
| Degree and duration of motor block |  | Intraoperative and 24 hour | 
| Intraoperative analgesic supplementation during operation |  | Intraoperative | 
| Postoperative pain scores for 24 hours |  | 24 hour | 
| Frequency and total dose of postoperative analgesics |  | 24 hour | 
| Intraoperative and postoperative sedation scores |  | Intraoperative and 24 hour | 
| Incidence of side effects: nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation. |  | Intraoperative and 24 hour | 
| Hospital in stay |  | 24 hour | 
| Time to S1 level sensory regression |  | Intraoperative and 24 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean Section, Intrathecal Dexmedetomidine