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Trial record 12 of 326 for:    clonidine

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

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ClinicalTrials.gov Identifier: NCT02550444
Recruitment Status : Completed
First Posted : September 15, 2015
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Pregnancy Drug: Intrathecal Clonidine Drug: Intravenous Clonidine Drug: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Intravenous and Intrathecal Clonidine in Post-cesarean Analgesia
Study Start Date : April 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
Intravenous and 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).
Other Name: Saline

Experimental: 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: 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).
Other Name: Clonidine

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




Primary Outcome Measures :
  1. Umbilical Artery Blood Gas Analysis - pH [ Time Frame: Right after born ]
    pH

  2. Umbilical Artery Serum Lactate [ Time Frame: Right after born ]
    Lactate

  3. Newborn Apgar Score [ Time Frame: First, Fifth and Tenth minutes after born ]
    Score can vary from 0 to 10.


Secondary Outcome Measures :
  1. Maternal heart rate [ Time Frame: Intraoperatively ]
    Heart rate during anesthesia

  2. Maternal blood pressure variation [ Time Frame: Intraoperatively ]
    Maximum and minimum blood pressure values

  3. Numerical verbal scale for pain [ Time Frame: 6, 12, 24 and 48 hours after cesarean section ]
    Score varies from 0 to 10

  4. Maternal sedation [ Time Frame: Intraoperatively ]
    Richmond Agitation and Sedation Scale (varies from -5 to +4)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • term pregnancy;
  • elective cesarean (no labor).

Exclusion Criteria:

  • multiple pregnancy;
  • moderate or several systemic disease, categorized as American Society of Anesthesiology physical status (ASA) higher or equal to 3;
  • contraindications for spinal anesthesia;
  • contraindications for the drugs involved in the study;
  • uncontrolled high blood pressure or diabetes mellitus in need of insulin therapy;
  • intravenous psychotropic drugs users;
  • previously known malformation on the fetus;
  • patients with previous history of chronic pain.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02550444


Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Hermann S Fernandes, MD Clinics Hospital of University of São Paulo Medical School

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02550444     History of Changes
Other Study ID Numbers: CAAE 05847312.8.0000.0068
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: September 2015
Keywords provided by University of Sao Paulo General Hospital:
Clonidine
Anesthesia, Obstetrical
Additional relevant MeSH terms:
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Clonidine
Fentanyl
Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action