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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Active Comparator | spinal anesthesia and intravenous dexmedetomidine(1µg/kg) |
|
| Saline | Placebo Comparator | spinal anesthesia and placebo (saline). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine Injectable Product | Drug | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| sensory and motor blocks | time to onset of sensory and motor blocks | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Elsawy, MD | Al-Azhar University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Azhar University Faculty of Medicine | Cairo | Egypt |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| Saline | Drug | 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. |
|
|
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |