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Peri-operative Dexmedetomidine Infusion in Pre-eclamptic Patients

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ClinicalTrials.gov Identifier: NCT03391609
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmad Mohammad Abd El-Rahman, Assiut University

Brief Summary:
The purpose of this study is to investigate the effects of dexmedetomidine infusion on the stress response to intubation, postoperative analgesia, and renal functions (urinary output [UOP], creatinine and glomerular filtration rate [GFR]) in preeclamptic patient.

Condition or disease Intervention/treatment Phase
Pre-Eclampsia Drug: placebo infusion Drug: Dexmedetomidine infusion Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: double-blinding
Primary Purpose: Treatment
Official Title: Peri-operative Dexmedetomidine Infusion in Mild Pre-eclamptic Patients Undergoing Elective Cesarean Section Under General Anesthesia
Actual Study Start Date : June 18, 2017
Estimated Primary Completion Date : February 1, 2018
Estimated Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Placebo Comparator: control group
Caesarian section will be performed under standard general anesthesia plus pre and intra operative saline infusion (placebo) in the same rate as dexmedetomedine starting 15 minutes before induction of general anesthesia and continue till peritoneum closure.
Drug: placebo infusion
Caesarian section will be performed under standard general anesthesia plus pre and intra operative saline infusion (placebo) in the same rate as dexmedetomedine starting 15 minutes before induction of general anesthesia and continue till peritoneum closure.

Active Comparator: Dex. group
Caesarian section will be performed under standard general anesthesia plus pre and intra operative Dexmedetomidine infusion in a dose of 0.5mic/kg/hour starting 15 minutes before induction of general anesthesia and continue till peritoneum closure.
Drug: Dexmedetomidine infusion
Caesarian section will be performed under standard general anesthesia plus pre and intra operative Dexmedetomidine infusion in a dose of 0.5mic/kg/hour starting 15 minutes before induction of general anesthesia and continue till peritoneum closure.




Primary Outcome Measures :
  1. postoperative analgesia [ Time Frame: 24 hours postoperatively ]
    through VAS score readings


Secondary Outcome Measures :
  1. stress response to intubation [ Time Frame: 24 hours postoperatively ]
    noradrenaline blood level

  2. stress response to intubation [ Time Frame: 24 hours postoperatively ]
    heart rate

  3. stress response to intubation [ Time Frame: 24 hours postoperatively ]
    mean arterial blood pressure

  4. renal function [ Time Frame: 24 hours postoperatively ]
    urinary output

  5. renal function [ Time Frame: 24 hours postoperatively ]
    serum creatinine level

  6. renal function [ Time Frame: 24 hours postoperatively ]
    glomerular filtration rate

  7. untoward events [ Time Frame: 24 hours postoperatively ]
    eclampsia, drug side effects (over sedation, hypotension, bradycardia)



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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant women
  • have mild preeclampsia ( Pre-eclamptic patients will be defined as having hypertension [systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP)≥90 mmHg] accompanied by proteinuria first detected after 20 weeks of gestation).
  • Proteinuria is defined as at least 300 mg protein in 24 h urine collection [or ≥1+ dipstick (30 mg/dl) in a single urine sample] ).
  • American Society of Anesthesiologists (ASA) physical status of II or III.
  • age between 19 and 40 years

Exclusion Criteria:

  • patient refusal to consent (obsolete).
  • pre-existing neurological disease or psychic patients.
  • history of cardiac and respiratory system failure.
  • co-existing significant renal or liver disease.

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): NCT03391609


Contacts
Contact: Ahmad M Abd EL-Rahman, M.D. 01000525368 ext 002 ahmad23679@gmail.com

Locations
Egypt
South Egypt Cancer Institute Recruiting
Assiut, Egypt, 171516
Contact: Ahmad M Abd El-Rahman, M.D.    01000525368 ext 002    ahmad23679@@gmail.com   
Sponsors and Collaborators
Assiut University

Responsible Party: Ahmad Mohammad Abd El-Rahman, lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03391609     History of Changes
Other Study ID Numbers: 144
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Eclampsia
Pre-Eclampsia
Pregnancy Complications
Anesthetics
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action