Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03740399
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Sevtap Hekimoglu Sahin, Trakya University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Regional Anesthesia Morbidity Procedure: spinal anesthesia Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Modified 45-degree Head-up Tilt Position in Cesarean Operation to the Success of Spinal Anesthesia
Actual Study Start Date : April 19, 2018
Estimated Primary Completion Date : March 28, 2019
Estimated Study Completion Date : June 28, 2019

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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant womans
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740399


Contacts
Layout table for location contacts
Contact: Sevtap Hekimoglu Sahin, Professor +90-284-235-76-41 sevtaphekimoglu@mynet.com
Contact: Beyhan Karamanlıoglu beykar@mynet.com

Locations
Layout table for location information
Turkey
Trakya University Recruiting
Edirne, Centrum, Turkey, 22030
Contact: Sevtap Hekimoglu Sahin, Professor       sevtaphekimoglu@mynet.com   
Contact: Beyhan Karamanlıoglu, Professor       beykar@mynet.com   
Sponsors and Collaborators
Trakya University
Investigators
Layout table for investigator information
Principal Investigator: Sevtap Hekimoglu Sahin, Proffesor Trakya University

Layout table for additonal information
Responsible Party: Sevtap Hekimoglu Sahin, Clinical Professor, Trakya University
ClinicalTrials.gov Identifier: NCT03740399     History of Changes
Other Study ID Numbers: TÜTF-BAEK 2018/79
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sevtap Hekimoglu Sahin, Trakya University:
sitting position
lateral decubitus position
spinal block

Additional relevant MeSH terms:
Layout table for MeSH terms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs