Comparison the effect of Dexmedetomidine plus Bupivacanie and Bupivacanie on maternal hemodynamic parameters and pain; and neonatal APGAR and arterial blood gases

Phase 3

Recruiting

• Conditions: Cesarean delivery.; Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section; O75.82

• Registration Number: IRCT20181107041590N1
• Lead Sponsor: Gorgan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 January 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

Pregnant women with repeated cesarean delivery and more than 39 gestational age
Age between 18 to 40 years old
Candidate for elective cesarean delivery underwent spinal anesthesia
American Society of Anesthesiologists (ASA) physical status classification system I and II
Without history of asthma, cardiovascular diseases, diabetes, acute and chronic renal failure, deep vein thrombosis, pulmonary embolism, peripheral vascular diseases, preeclampsia, eclampsia, seizure, convulsion, and cancers
Without history of drug abuse or sedative & hypnotic drugs
Without congenital malformation
Without history of airway problems and systemic diseases, and preterm labor
Without history of medication allergy
Without coagulopathy
Hemoglobin level above 10 g/dl
Normal level of clotting time (CT), bleeding time (BT), prothrombin time (PT), partial thromboplastin time (PTT), and international normalized ratio (INR)
Having at least two clinical visit with obstetrician and one blood test and 2 control sonography during pregnancy in pregnancy record
Filling the informed consent form

Exclusion Criteria

Use of sedative and hypnotic drugs before surgery
Use of anticoagulants 48 hours before surgery
With psychiatric disorders

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemodynamic parameters (heart rate and blood pressure). Timepoint: Before and 1, 5,15, 30 and 60 minute after surgery. Method of measurement: Vital-signs monitoring device.

Secondary Outcome Measures

Name	Time	Method
Maternal pain. Timepoint: Before and 1, 6, 12 and 24 hours after surgery. Method of measurement: Visual analogous scale.;Neonatal APGAR. Timepoint: 1st and 5th minute after birth. Method of measurement: APGAR scale.;Arterial blood gases. Timepoint: After birth. Method of measurement: Arterial blood gases analysis.