Cesarean Section Complications
Conditions
Keywords
dexmedetomidine, spinal anesthesia, cesarean section, epigastric pain
Brief summary
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
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.
Interventions
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.
DRUGSaline
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.
Sponsors
Egyptian Biomedical Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hypotension | up to 48 hours postoperative | systolic blood pressure \< 90 mmHg |
| ephedrine use | up to 48 hours postoperative | frequency of ephedrine doses needed |
| sedation | up to 48 hours postoperative | sedation score |
| epigastric pain | up to 48 hours postoperative | Pain in the epigastric region assessed by Visual Analog Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sensory and motor blocks | Intraoperative | time to onset of sensory and motor blocks |
Countries
Egypt
Outcome results
None listed