Peri-operative Dexmedetomidine Infusion in Pre-eclamptic Patients

NCT ID: NCT03391609

Last Updated: 2019-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-18

Study Completion Date

2019-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pre-Eclampsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
double-blinding

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

placebo infusion

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine infusion

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Mohammad Abd El-Rahman

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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South Egypt Cancer Institute

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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144

Identifier Type: -

Identifier Source: org_study_id

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