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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verified this record recently (last verified Oct 2017), so the status shown — last known as Not yet recruiting — may be out of date.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
03

In context

Lead sponsor

Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Mansoura University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients scheduled for elective surgery under spinal anesthesia

Exclusion criteria

Exclusion Criteria:

  • ischemic heart disease uncontrolled hypertension
05

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

06

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

07

Study locations

1 site
  • Mansoura university
    Al Manşūrah, Dkahleya, Egypt
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2017; primary completion for Jan 2018, 2 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2017
First posted
Oct 12, 2017
StartEst.
Nov 1, 2017
Primary completionEst.
Jan 1, 2018
CompletionEst.
Jan 1, 2018
Last update
Oct 12, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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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Discussion

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