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Impact of Intrathecal vs Intravenous Dexmedetomidine

NCT06410365 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-13

No results posted yet for this study

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

Conditions

  • Nausea and Vomiting, Postoperative

Interventions

DRUG

Dexmedetomidine injection

Comparison of intravenous and intrathecal route of dexmedetomidine

Sponsors & Collaborators

  • Muhammad Ilyas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06410365 on ClinicalTrials.gov