CompletedPhase 3Phase 4ACTRN12615000575538

The hemodynamic effects of Combined Epinephrine and Clonidine added to intrathecal Bupivacaine in cesarean section

Evaluation of hemodynamic effects of Combined Epinephrine and Clonidine added to intrathecal Bupivacaine , in patients undergoing cesarean section


Sponsor

Qazvin Medical Science University

Enrollment

96 participants

Start Date

Jun 23, 2013

Study Type

Interventional

Conditions

Summary

Objective :To compare the hemodynamic effects of combined intrathecal Clonidine and Epinephrin as an additive to bupivacaine in patients undergoing cesarean section . Methods:Following Ethics Committee approval and informed patients consent, Ninety patients 18-40 yr old ASA physical status I or II, scheduled for cesarean section under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups. The Clonidine group (groupC) received bupivacaine 10mg combined with 75 microgram clonidine preservative free ,the Epinephrin-Clonidin group (group E-C) received bupivacaine 10mg combined with 35 microgram Clonidin and 200 microgram Epinephrin, and the placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .Intraoperative changes in hemodynamics variables [Mean Blood pressuer(MBP) and Heart Rate( HR)], Sensory block onset time, maximum sensory level , onset of motor block, duration of blockade, the incidence of hypotension, ephedrine requirements, bradycardia , neonate's APGAR 1 & 5 minute were recorded. MBP was measured and monitored by automated non-invasive blood pressure in arm and HR was recorded by Electrocardiogram(ECG).


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 40 Yearss

Inclusion Criteria1

  • Patients with American Society of Anesthesiologists(ASA) physical status I and II, undergoing elective cesarean section under spinal anesthesia

Exclusion Criteria1

  • Significant coexisting disease such as hepatic,renal and cardiovascular disease, any contraindication to regional anesthesia such as local infection or bleeding disorders, allergy to clonidine , long-term opioid use or a history of chronic hypertension , preeclampsia , eclampsia,fetal distress

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Interventions

Ninety patients 18-40 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for cesarean section under spinal anesthesia, were studied in a prospective, double-blinde

Ninety patients 18-40 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for cesarean section under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups.The Clonidine group (group C) received bupivacaine 10 mg combined with 75 microgramg Clonidine preservative free solution ,The Epinephrin-Clonidin group (group E-C) received bupivacaine 10mg combined with 35 microgramg Clonidin and 200 microgram Epinephrin. The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water(intrathecally) for each three groups 5 minutes prior to surgery.


Locations(1)

Qazvin, Iran, Islamic Republic Of

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ACTRN12615000575538