drugset / Trial / NCT06410365

Impact of Intrathecal vs Intravenous Dexmedetomidine

NCT06410365 ↗

Phase 4 Unknown 60 enrolled Muhammad Ilyas
RandomizedParallel-groupSingle-blindPrevention

Summary

The purpose of this research is to evaluate the impact of intrathecal dexmedetomidine in comparison with intravenous route in patients undergoing cesarean section. Alternate hypothesis :Dexmedetomidine is more effective when given intrathecally as adjuvant to bupivacaine in elective cesarean section Null Hypothesis: Dexmedetomidine is more effective when given intravenously as adjuvant to bupivacaine in elective cesarean section Study Design: Randomized controlled trial Study setting: Watim General Hospital Study Duration: 18 months after synopsis approval Sampling technique: Simple random sampling Sample Size: Using the Open Epi program, a sample size of 60 patients (30 in each group) was determined with a 95% confidence interval and 80% power. Inclusion Criteria: * Pregnant women between ages 18-35 years * Belongs to ASA class I or II * Subjected to elective C-section Exclusion Criteria: * Any history of gastrointestinal disease diabetes, thyroid disease, hypertension, obesity, or anemia * History of alcohol or drug abuse; * Major complications of pregnancy * Patients have contraindication to spinal block or allergic to any of drug

Timeline

Start
2024-06-01
Primary completion
2024-10-31
Completion
2024-12-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 1 ug/kg Intrathecal
Subject Dexmedetomidine Other / unclassified 5 ug Intrathecal

Indications

No indication recorded.