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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000575538

Enrollment

Registered

2015-06-03

Start date

2013-06-23

Completion date

2014-02-20

Last updated

2020-01-13

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

Conditions

None listed

Brief 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).

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-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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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

Outcome results