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

Comparison the effect of interathecal injection of Dexmedetomidine plus Bupivacanie and Bupivacanie on maternal hemodynamic parameters and pain; and neonatal APGAR and arterial blood gases of women undergoing cesarean delivery under spinal anesthesia

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181107041590N1
Enrollment
82
Registered
2019-01-05
Start date
2019-01-10
Completion date
Unknown
Last updated
2019-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Intervention 1: Intervention group: Intrathecal injection of 2.5 ml of Bupivacanie 0.5% (Astra Zeneca company, Sweden) plus 5 µg of Dexmedetomidine (Pfizer company, US) (total volume of 3.0 ml). Inte

Sponsors

Gorgan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMonireh Jahani

Gorgan University of Medical Sciences

jahani.mn@goums.ac.ir+98 17 3232 0370

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026