Peri-operative Dexmedetomidine Infusion in Pre-eclamptic Patients

Peri-operative Dexmedetomidine Infusion in Mild Pre-eclamptic Patients Undergoing Elective Cesarean Section Under General Anesthesia

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03391609

Enrollment

Registered

2018-01-05

Start date

2017-06-18

Completion date

2019-01-01

Last updated

2019-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-Eclampsia

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.

Interventions

DRUGplacebo 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.

DRUGDexmedetomidine 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Masking description

double-blinding

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
postoperative analgesia	24 hours postoperatively	through VAS score readings

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026