CClinicalTrials.gg
Sign In
CompletedNCT03391609Updated Feb 26, 2019

Peri-operative Dexmedetomidine Infusion in Pre-eclamptic Patients

A Phase 2/3 interventional study of placebo infusion and Dexmedetomidine infusion in Pre-Eclampsia, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 19 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-26.

Sponsored by Assiut University · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
19 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Pre-Eclampsia
03

Who can participate

Ages eligible
19 Years to 40 Years
Sexes eligible
Female
Accepts 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

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.
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Placebo comparator
    control group

    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

  • Active comparator
    Dex. group

    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

  • 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.

05

What researchers measure

Primary outcomes

  1. postoperative analgesia

    through VAS score readings

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. stress response

    mean arterial blood pressure

    Time frame: 24 hours postoperatively

  2. renal function

    glomerular filtration rate

    Time frame: 24 hours postoperatively

  3. untoward events

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

    Time frame: 24 hours postoperatively

06

Study locations

1 site
  • South Egypt Cancer Institute
    Assiut, 171516, Egypt
07

Registry details

Key details

Study ID
NCT03391609
Lead sponsor
Assiut University
Responsible party
Ahmad Mohammad Abd El-Rahman (lecturer, Assiut University) — Principal investigator
First posted
Jan 5, 2018
Start date
Jun 18, 2017
Primary completion
Nov 1, 2018
Completion
Jan 1, 2019
Last update
Feb 26, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Eclampsia→

Other studies from this sponsor

Assiut University

Start the discussion