Clinical Trial: The Effect of Intravenous Dexmedetomidine on the Duration of Spinal Block and Postoperative Pain in Women Undergoing Cesarean Section (Japan)

Tokyo, Aug. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058861) titled 'The Effect of Intravenous Dexmedetomidine on the Duration of Spinal Block and Postoperative Pain in Women Undergoing Cesarean Section' on Aug. 22.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - School of Pharmacy, Shahid Sadoughi University of Medical Sciences, Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran

Condition: Condition - it is thesis of pharmacy student that was done at the university hospital Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Evaluate whether an intravenous bolus of dexmedetomidine given with spinal anesthesia prolongs sensory and motor block duration, shortens sensory block onset, reduces postoperative pain up to 24 hours, and affects peri-/post-operative adverse events in women undergoing non-emergency cesarean section.Postoperative pain intensity measured by Visual Analog Scale (0-10) at 2, 6, 12, and 24 hours after cesarean section Basic objectives2 - Pharmacodynamics

Intervention: Interventions/Control_1 - Participants were randomized into two groups using a computer generated sequence:

Dexmedetomidine group (n=25): Received 12.5 mg of 0.5% hyperbaric bupivacaine intrathecally and an intravenous bolus of dexmedetomidine (0.2 mcg/kg) over 10 minutes after delivery. Interventions/Control_2 - Control group (n=25): Received 12.5 mg of 0.5% hyperbaric bupivacaine intrathecally and an intravenous bolus of normal saline (0.2 mcg/kg).

Eligibility: Age-lower limit - 18 years-old = Gender - Female Key inclusion criteria - American Society of Anesthesiologists physical status 1 and 2. Age 18-40 years. Full term pregnancy (37-40 weeks). Key exclusion criteria - History of adverse reactions to local anesthetics or dexmedetomidine. Contraindications to spinal anesthesia. Emergency cesarean sections. Target Size - 50

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2017 Year 10 Month 01 Day Date of IRB - 2017 Year 11 Month 22 Day Anticipated trial start date - 2018 Year 12 Month 10 Day Last follow-up date - 2024 Year 11 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067289

Disclaimer: Curated by HT Syndication.