Low Dose Spinal Anesthesia in Cesarean Surgery

NCT02563795 | Completed

• 1 other identifier: ANK-42479
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Hypotension; Anesthesia

Keywords

Spinal anesthesia; Cesarean; Maternal hypotension

Outcome Measures

Primary Outcomes (1)

• VAS score < 6 with only spinal anesthesia

  Achieving surgical anesthesia with low dose spinal anesthesia in obese pregnants

  Approximately 30 min, during surgery

Secondary Outcomes (1)

• Maternal hypotension

  Approximately 30 min, during surgery

Study Arms (4)

Group I

Pregnant with BMI\<30 and having spinal anesthesia with 10 mg hyperbaric bupivacaine

Drug: Bupivacaine

Group II

Pregnant with BMI\<30 and having spinal anesthesia with 7,5 mg hyperbaric bupivacaine+25 mcg fentanyl

Drug: Fentanyl

Group III

Pregnant with BMI\>30 and having spinal anesthesia with 10 mg hyperbaric bupivacaine

Drug: Bupivacaine

Group IV

Pregnant with BMI\>30 and having spinal anesthesia with 7,5 mg hyperbaric bupivacaine+25 mcg fentanyl

Drug: Fentanyl

Interventions

Bupivacaine DRUG

To compare low dose spinal anesthesia with bupivacaine alone if it can maintain surgical anesthesia during cesarean section in obese and non-obese pregnants

Also known as: Fentanyl

Group I; Group III

Fentanyl DRUG

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

Also known as: Bupivacaine

Group II; Group IV

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients undergoing cesarean section under spinal anesthesia in obstetric clinic

You may qualify if:

• Pregnant patients

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Cigdem Yildirim Guclu

Ankara, 06550, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Bupivacaine; Fentanyl

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• CIGDEM YILDIRIM GUCLU, MD

  Ankara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 30, 2015
• Study Start: May 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: March 15, 2016

Record last verified: 2016-03

Locations

TU (1)