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Low Dose Spinal Anesthesia in Cesarean Surgery

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02563795
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
CIGDEM YILDIRIM GUCLU, Ankara University

Brief Summary:
Anesthesia for cesarean section requires special importance because it may affect both mother and the baby. To avoid maternal hypotension related to spinal anesthesia must be the primary objective during anesthesia. Even though many factors influence sensory nerve block for surgical anesthesia, local anesthetic dose is the main determinant. Another factor that influence the sensory nerve block is the obesity related to pregnancy. Due to the enlargement of epidural venous plexus related to pregnancy, the subarachnoid and epidural space reduces, so the local anesthetic requirement also reduces. Many investigators recommend lower dose of local anesthetic in obese patients due to reduced requirement There are many studies about dose regimens for cesarean anesthesia, but ideal dose have not been found. Investigators have designed this study to see the effects of conventional dose (10 mg bupivacaine) vs. low dose plus fentanyl (7,5 mg bupivacaine+25 mcg fentanyl) in obese and normal weight pregnant for cesarean section. The hypothesis was: the low dose regimen provides surgical anesthesia in obese patients while avoiding maternal hypotension.

Condition or disease Intervention/treatment
Maternal Hypotension Anesthesia Drug: Bupivacaine Drug: Fentanyl

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Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Does the Reduction of Local Anesthetic Dose Provide Surgical Anesthesia While Avoiding Maternal Hypotension in Obese Pregnant for C/S by Single Shot Spinal Anesthesia?
Study Start Date : May 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group I
Pregnant with BMI<30 and having spinal anesthesia with 10 mg hyperbaric bupivacaine
Drug: Bupivacaine
To compare low dose spinal anesthesia with bupivacaine alone if it can maintain surgical anesthesia during cesarean section in obese and non-obese pregnants
Other Name: Fentanyl

Group II
Pregnant with BMI<30 and having spinal anesthesia with 7,5 mg hyperbaric bupivacaine+25 mcg fentanyl
Drug: Fentanyl
To compare low dose spinal anesthesia with bupivacaine+ fentanyl alone if it can maintain surgical anesthesia during cesarean section in obese and non-obese pregnants
Other Name: Bupivacaine

Group III
Pregnant with BMI>30 and having spinal anesthesia with 10 mg hyperbaric bupivacaine
Drug: Bupivacaine
To compare low dose spinal anesthesia with bupivacaine alone if it can maintain surgical anesthesia during cesarean section in obese and non-obese pregnants
Other Name: Fentanyl

Group IV
Pregnant with BMI>30 and having spinal anesthesia with 7,5 mg hyperbaric bupivacaine+25 mcg fentanyl
Drug: Fentanyl
To compare low dose spinal anesthesia with bupivacaine+ fentanyl alone if it can maintain surgical anesthesia during cesarean section in obese and non-obese pregnants
Other Name: Bupivacaine




Primary Outcome Measures :
  1. VAS score < 6 with only spinal anesthesia [ Time Frame: Approximately 30 min, during surgery ]
    Achieving surgical anesthesia with low dose spinal anesthesia in obese pregnants


Secondary Outcome Measures :
  1. Maternal hypotension [ Time Frame: Approximately 30 min, during surgery ]
    Avoiding maternal hypotension



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing cesarean section under spinal anesthesia in obstetric clinic
Criteria

Inclusion Criteria:

  • Pregnant patients

Exclusion Criteria:

  • Spinal anesthesia contraindications, thrombocytopenia, coagulation defects, cardiomyopathy, placenta previa, twin pregnancy, hypersensitivity to amide local anesthetics or fentanyl, infection at the injection site, neurologic disease.

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): NCT02563795


Locations
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Turkey
Cigdem Yildirim Guclu
Ankara, Turkey, 06550
Sponsors and Collaborators
Ankara University
Investigators
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Principal Investigator: CIGDEM YILDIRIM GUCLU, MD Ankara University
Additional Information:

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Responsible Party: CIGDEM YILDIRIM GUCLU, MD, Ankara University
ClinicalTrials.gov Identifier: NCT02563795    
Other Study ID Numbers: ANK-42479
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: March 2016
Keywords provided by CIGDEM YILDIRIM GUCLU, Ankara University:
Spinal anesthesia
Cesarean
Maternal hypotension
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Fentanyl
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General