Effect of Modified 45-degree Head-up Tilt Position in Cesarean Operation to the Success of Spinal Anesthesia (cesarean)

November 10, 2018 updated by: Sevtap Hekimoglu Sahin, Trakya University
The success of the application of spinal block in 3 different application as the sitting position, side decubitus position and 45 degrees head upside side decubitus position will be evaluated.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

180 patients in ASA I-II risk group between the ages of 18-50 will be included in the study.The success of the application of spinal block in 3 different application as the sitting position, side decubitus position and 45 degrees head upside side decubitus position will be evaluated. Anatomical features of height, weight, block application of the patients will be recorded.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Centrum
      • Edirne, Centrum, Turkey, 22030
        • Recruiting
        • Trakya University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • caesarean section
  • 18-50 years old
  • ASA I-II risk

Exclusion Criteria:

  • heart failure
  • patient's refusal
  • thrombocytopenia
  • coagulation disorder
  • heart valve diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group sitting
we are performing spinal anesthesia in sitting position pregnant patients
Procedure: spinal anesthesia
Investigators will perform spinal anesthesia for section
Active Comparator: Group lateral decubitus position
we are performing spinal anesthesia in lateral decubitus position pregnant patients
Procedure: spinal anesthesia
Investigators will perform spinal anesthesia for section
Active Comparator: Group Modified 45-degree head-up tilt
we are performing spinal anesthesia in Modified 45-degree head-up tilt position pregnant patients
Procedure: spinal anesthesia
Investigators will perform spinal anesthesia for section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
spinal anesthesia success
Time Frame: spinal anesthesia success will be 15 minutes in intraoperative
The free flow of clear cerebrospinal fluid (CSF) upon first attempt was considered to be evidence of a successful LP.
spinal anesthesia success will be 15 minutes in intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trakya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2018

Primary Completion (Anticipated)

March 28, 2019

Study Completion (Anticipated)

June 28, 2019

Study Registration Dates

First Submitted

October 19, 2018

First Submitted That Met QC Criteria

November 10, 2018

First Posted (Actual)

November 14, 2018

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 10, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TÜTF-BAEK 2018/79

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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