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OpenTrials
Completed

NCT Number: NCT02563795

Low Dose Spinal Anesthesia in Cesarean Surgery

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Cigdem Yildirim Guclu

Ankara, 06550, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Fentanyl

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

Other names: Bupivacaine

Primary outcomes

  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 outcomes

  1. Maternal hypotension

    Time frame: Approximately 30 min, during surgery

    Avoiding maternal hypotension

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study 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?

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 30, 2015
Registry last updated
Mar 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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