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NOT YET RECRUITING
NCT06410365
PHASE4

Impact of Intrathecal vs Intravenous Dexmedetomidine

Sponsor: Muhammad Ilyas

View on ClinicalTrials.gov

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

Official title: Impact of Intrathecal Versus Intravenous Dexmedetomidine Adjuvant to Bupivacaine in Elective Cesarian Section

Key Details

Gender

FEMALE

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-06-01

Completion Date

2024-12-31

Last Updated

2024-05-13

Healthy Volunteers

Yes

Interventions

DRUG

Dexmedetomidine injection

Comparison of intravenous and intrathecal route of dexmedetomidine