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Norepinephrine for Spinal-induced Hypotension (NE in spianl)

Primary Purpose

Spinal Anesthesia

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Norepinephrine infusion
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Anesthesia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients scheduled for elective surgery under spinal anesthesia

Exclusion Criteria:

  • ischemic heart disease uncontrolled hypertension

Sites / Locations

  • Mansoura university

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

NE group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 9, 2017
Last Updated
October 9, 2017
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03308708
Brief Title
Norepinephrine for Spinal-induced Hypotension
Acronym
NE in spianl
Official Title
Prophylactic Norepinephrine Infusion for Spinal-induced Hypotension
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Anticipated)
Primary Completion Date
January 1, 2018 (Anticipated)
Study Completion Date
January 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Title
NE group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Norepinephrine infusion
Intervention Description
Norepinephrine infusion (5miclml) is immediately started after spinal anesthesia. Rate starts at 30 ml/h and modified according to hemodynamic state
Primary Outcome Measure Information:
Title
incidence of hypotension
Description
intraoperative decrease of patient blood pressure by more than 20% from its basal reading
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients scheduled for elective surgery under spinal anesthesia Exclusion Criteria: ischemic heart disease uncontrolled hypertension
Facility Information:
Facility Name
Mansoura university
City
Al Manşūrah
State/Province
Dkahleya
Country
Egypt

12. IPD Sharing Statement

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Norepinephrine for Spinal-induced Hypotension

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