- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03740399
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 Contact
- Name: Sevtap Hekimoglu Sahin, Professor
- Phone Number: +90-284-235-76-41
- Email: sevtaphekimoglu@mynet.com
Study Contact Backup
- Name: Beyhan Karamanlıoglu
- Email: beykar@mynet.com
Study Locations
-
-
Centrum
-
Edirne, Centrum, Turkey, 22030
- Recruiting
- Trakya University
-
Contact:
- Beyhan Karamanlıoglu, Professor
- Email: beykar@mynet.com
-
-
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
|
Investigators will perform spinal anesthesia for section
|
Active Comparator: Group lateral decubitus position
we are performing spinal anesthesia in lateral decubitus position pregnant patients
|
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
|
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
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
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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