Peri-operative Dexmedetomidine Infusion in Pre-eclamptic Patients

Assiut University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pre-Eclampsia

Treatments: Drug: Dexmedetomidine infusion; Drug: placebo infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03391609

144

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 19 to 40 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

control group

Placebo Comparator group

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.

Treatment:

Drug: placebo infusion

Dex. group

Active Comparator group

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.

Treatment:

Drug: Dexmedetomidine infusion