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Intrathecal Clonidine in Cesarean Section May Lead to Worse Blood Gas Results in the Newborns

NCT02550444 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2017-11-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate effects of intravenous clonidine in acute and chronic post-cesarean pain, possible adverse effects over mother-newborn pair, in comparison to intrathecal adjuvant clonidine and placebo.

Conditions

  • Pregnancy

Interventions

DRUG

Intrathecal Clonidine

Intrathecal Adjuvant Clonidine 75 mcg; Intravenous Placebo (Saline 0,9%); Intrathecal heavy Bupivacaine 0,5% (15mg), morphine 0,02 (80mcg) and fentanyl (10mcg).

DRUG

Intravenous Clonidine

Intravenous Clonidine 75 mcg; Intrathecal Placebo (Saline 0,9%); Intrathecal heavy Bupivacaine 0,5% (15mg), morphine 0,02 (80mcg) and fentanyl (10mcg).

DRUG

Placebo

Intravenous and intrathecal Placebo (Saline 0,9%); Intrathecal heavy Bupivacaine 0,5% (15mg), morphine 0,02 (80mcg) and fentanyl (10mcg).

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Hermann S Fernandes, MD · Clinics Hospital of University of São Paulo Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-05-31
Completion
2016-06-30

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02550444 on ClinicalTrials.gov