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Completed

NCT Number: NCT03391609

Peri-operative Dexmedetomidine Infusion in Pre-eclamptic Patients

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.

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Key information

Conditions

Pre-eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

South Egypt Cancer Institute

Asyut, 171516, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

placebo infusion

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.

Dexmedetomidine infusion

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.

Primary outcomes

  1. postoperative analgesia

    Time frame: 24 hours postoperatively

    through VAS score readings

Secondary outcomes

  1. stress response

    Time frame: 24 hours postoperatively

    mean arterial blood pressure

  2. renal function

    Time frame: 24 hours postoperatively

    glomerular filtration rate

  3. untoward events

    Time frame: 24 hours postoperatively

    eclampsia, drug side effects (over sedation, hypotension, bradycardia)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 5, 2018
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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