Peri-operative Dexmedetomidine Infusion in Pre-eclamptic Patients

Phase 2

Completed

• Conditions: Pre-Eclampsia
• Interventions: Drug: Dexmedetomidine infusion; Drug: placebo infusion

• Registration Number: NCT03391609
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-18
• Study First Submitted: 2017-12-18
• Study First Submitted QC: 2018-01-01
• Study First Posted: 2018-01-05
• Primary Completion: 2018-11-01
• Study Completion: 2019-01-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-22
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dex. group	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.
control group	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.

Primary Outcome Measures

Name	Time	Method
postoperative analgesia	24 hours postoperatively	through VAS score readings

Secondary Outcome Measures

Name	Time	Method
renal function	24 hours postoperatively	glomerular filtration rate
untoward events	24 hours postoperatively	eclampsia, drug side effects (over sedation, hypotension, bradycardia)
stress response	24 hours postoperatively	mean arterial blood pressure

Trial Locations

Locations (1)

South Egypt Cancer Institute; 🇪🇬 Assiut, Egypt