Low Dose Spinal Anesthesia in Cesarean Surgery

Anesthesia Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02563795
• Other study ID #: ANK-42479
• Status: Completed
• Phase: N/A
• First received: September 18, 2015
• Last updated: March 14, 2016
• Start date: May 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia
• Hypotension
• Maternal Hypotension

Intervention

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
• 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

Locations

Country	Name	City	State
Turkey	Cigdem Yildirim Guclu	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS score < 6 with only spinal anesthesia	Achieving surgical anesthesia with low dose spinal anesthesia in obese pregnants	Approximately 30 min, during surgery	Yes
Secondary	Maternal hypotension	Avoiding maternal hypotension	Approximately 30 min, during surgery	Yes