Peri-operative Dexmedetomidine Infusion in Pre-eclamptic Patients

NCT03391609 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 144
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

• postoperative analgesia

  through VAS score readings

  24 hours postoperatively

Secondary Outcomes (3)

• stress response

  24 hours postoperatively

• renal function

  24 hours postoperatively

• untoward events

  24 hours postoperatively

Study Arms (2)

control group

PLACEBO COMPARATOR

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.

Drug: placebo infusion

Dex. group

ACTIVE COMPARATOR

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.

Drug: Dexmedetomidine infusion

Interventions

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.

control group

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.

Dex. group

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

South Egypt Cancer Institute

Asyut, 171516, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blinding
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: January 5, 2018
• Study Start: June 18, 2017
• Primary Completion: November 1, 2018
• Study Completion: January 1, 2019
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

EG (1)