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Status unknownNCT03308708NE in spianlUpdated Oct 12, 2017

Norepinephrine for Spinal-induced Hypotension

An interventional study of Norepinephrine infusion in Spinal Anesthesia, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-10-12.

Sponsored by Mansoura University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

Norepinephrine (NE) infusion is used prophylactically to counteract the vasodilator effect of spinal anesthesia. prophylactic use of NE infusion is expected to decrease bouts of hypotension, vomiting and increase patient satisfaction

02

Conditions studied

  • Spinal Anesthesia

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03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients scheduled for elective surgery under spinal anesthesia

Exclusion criteria

Exclusion Criteria:

  • ischemic heart disease uncontrolled hypertension
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • No intervention
    Control group
  • Experimental
    NE group

    Drug: Norepinephrine infusion

Interventions

  • DrugNorepinephrine infusion

    Norepinephrine infusion (5miclml) is immediately started after spinal anesthesia. Rate starts at 30 ml/h and modified according to hemodynamic state

05

What researchers measure

Primary outcomes

  1. incidence of hypotension

    intraoperative decrease of patient blood pressure by more than 20% from its basal reading

    Time frame: intraoperative

06

Study locations

1 site
  • Mansoura university
    Al Manşūrah, Dkahleya, Egypt
07

Registry details

Key details

Study ID
NCT03308708
Lead sponsor
Mansoura University
Responsible party
AlRefaey Kandeel (Dr, Mansoura University) — Principal investigator
First posted
Oct 12, 2017
Start date
Nov 1, 2017 (estimated)
Primary completion
Jan 1, 2018 (estimated)
Completion
Jan 1, 2018 (estimated)
Last update
Oct 12, 2017

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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