Peri-operative Dexmedetomidine Infusion in Pre-eclamptic Patients

Pre-Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03391609
• Other study ID #: 144
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 18, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: February 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 1, 2019
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	South Egypt Cancer Institute	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative analgesia	through VAS score readings	24 hours postoperatively
Secondary	stress response	mean arterial blood pressure	24 hours postoperatively
Secondary	renal function	glomerular filtration rate	24 hours postoperatively
Secondary	untoward events	eclampsia, drug side effects (over sedation, hypotension, bradycardia)	24 hours postoperatively