Low Dose Spinal Anesthesia in Cesarean Surgery

Completed

• Conditions: Maternal Hypotension; Anesthesia
• Interventions: Drug: Bupivacaine; Drug: Fentanyl

• Registration Number: NCT02563795
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-30
• Primary Completion: 2016-01
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group I	Bupivacaine	Pregnant with BMI\<30 and having spinal anesthesia with 10 mg hyperbaric bupivacaine
Group II	Fentanyl	Pregnant with BMI\<30 and having spinal anesthesia with 7,5 mg hyperbaric bupivacaine+25 mcg fentanyl
Group III	Bupivacaine	Pregnant with BMI\>30 and having spinal anesthesia with 10 mg hyperbaric bupivacaine
Group IV	Fentanyl	Pregnant with BMI\>30 and having spinal anesthesia with 7,5 mg hyperbaric bupivacaine+25 mcg fentanyl

Primary Outcome Measures

Name	Time	Method
VAS score < 6 with only spinal anesthesia	Approximately 30 min, during surgery	Achieving surgical anesthesia with low dose spinal anesthesia in obese pregnants

Secondary Outcome Measures

Name	Time	Method
Maternal hypotension	Approximately 30 min, during surgery	Avoiding maternal hypotension

Trial Locations

Locations (1)

Cigdem Yildirim Guclu; 🇹🇷 Ankara, Turkey