Low Dose Spinal Anesthesia in Cesarean Surgery

March 14, 2016 updated by: CIGDEM YILDIRIM GUCLU, Ankara University

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?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

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
      • Ankara, Turkey, 06550
        • Cigdem Yildirim Guclu

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 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients undergoing cesarean section under spinal anesthesia in obstetric clinic

Description

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.

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

Cohorts and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Approximately 30 min, during surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal hypotension
Time Frame: Approximately 30 min, during surgery
Avoiding maternal hypotension
Approximately 30 min, during surgery

Collaborators and Investigators

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

Sponsor

Ankara University

Investigators

  • Principal Investigator: Çiğdem YILDIRIM GÜÇLÜ, MD, Ankara 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

May 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

September 18, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Estimate)

March 15, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANK-42479

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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