NCT03308708

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

2 months

First QC Date

October 9, 2017

Last Update Submit

October 9, 2017

Conditions

Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

  • incidence of hypotension

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

    intraoperative

Study Arms (2)

Control group

NO INTERVENTION

NE group

EXPERIMENTAL
Drug: Norepinephrine infusion

Interventions

Norepinephrine infusionDRUG

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

NE group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All patients scheduled for elective surgery under spinal anesthesia

You may not qualify if:

  • ischemic heart disease uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university

Al Manşūrah, Dkahleya, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 9, 2017

First Posted

October 12, 2017

Study Start

November 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

October 12, 2017

Record last verified: 2017-10

Locations

EG(1)