NCT02937792

Brief Summary

To test the safety of high dose spinal in elective CS after prolonged sitting position.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

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

Study Start

First participant enrolled

October 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

October 17, 2016

Last Update Submit

October 18, 2016

Conditions

Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

  • vital signs

    blood pressure, heart rate

    45 minutes

Secondary Outcomes (1)

  • complications

    45 minutes

Study Arms (2)

CONTROL

NO INTERVENTION

one with intrathecal 12.5 mg bupivacaine

experimental

EXPERIMENTAL

one group with intrathecal 15 mg bupivacaine

Drug: intrathecal 15 mg bupivacaine

Interventions

intrathecal 15 mg bupivacaineDRUG

spinal anesthesia with a large dose of bupivacaine 0.5% in elective caesarean section

Also known as: large dose spinal
experimental

Eligibility Criteria

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

You may qualify if:

  • Full term pregnant female indicated for the elective section under spinal anesthesia with no history of medical importance

You may not qualify if:

  • Urgent cases, emergency cases, adverse medical history, anticoagulant treatment, associated pregnancy complication, failed spinal, surgical complication or refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Giza Governorate, 1234, Egypt

RECRUITING

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Hassan Ali, lecturer

CONTACT

1001733687hassan364@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer in anesthesia department Cairo university

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 19, 2016

Study Start

October 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

October 19, 2016

Record last verified: 2016-10

Locations

EG(1)