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Peri-operative Dexmedetomidine Infusion in Pre-eclamptic Patients

Primary Purpose

Pre-Eclampsia

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
placebo infusion
Dexmedetomidine infusion
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pre-Eclampsia

Eligibility Criteria

19 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • South Egypt Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

control group

Dex. group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

postoperative analgesia
through VAS score readings

Secondary Outcome Measures

stress response
mean arterial blood pressure
renal function
glomerular filtration rate
untoward events
eclampsia, drug side effects (over sedation, hypotension, bradycardia)

Full Information

First Posted
December 18, 2017
Last Updated
February 22, 2019
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03391609
Brief Title
Peri-operative Dexmedetomidine Infusion in Pre-eclamptic Patients
Official Title
Peri-operative Dexmedetomidine Infusion in Mild Pre-eclamptic Patients Undergoing Elective Cesarean Section Under General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 18, 2017 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
double-blinding
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Dex. group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo infusion
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine infusion
Intervention Description
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 Measure Information:
Title
postoperative analgesia
Description
through VAS score readings
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
stress response
Description
mean arterial blood pressure
Time Frame
24 hours postoperatively
Title
renal function
Description
glomerular filtration rate
Time Frame
24 hours postoperatively
Title
untoward events
Description
eclampsia, drug side effects (over sedation, hypotension, bradycardia)
Time Frame
24 hours postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
South Egypt Cancer Institute
City
Assiut
ZIP/Postal Code
171516
Country
Egypt

12. IPD Sharing Statement

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Peri-operative Dexmedetomidine Infusion in Pre-eclamptic Patients

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