Low-Doses Of Isobaric Bupivacaine On Intraoperative Hemodynamics In Spinal Anesthesia During Cesarean Section

Study Overview
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Brief Summary
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The primary aim of this study was to compare the effects of two different low-dose bupivacaine used in spinal anesthesia on intraoperative hemodynamics in cesarean section operations.Investigators think that low-dose bupivacaine and fentanyl mixture applied in cesarean section cause fewer hemodynamic changes,provide adequate anesthesia and analgesia quality,cause fewer side effects,and postoperatively,patients may return to their daily activities more quickly.This study was conducted on 80 pregnant women undergo an elective cesarean section.Patients were randomly allocated in GrupA and GroupB. Combined spinal-epidural anesthesia was performed in the sitting position using the needle-inside-needle technique.After cerebrospinal fluid flow was observed, GroupA patients were given a solution containing 5 mg isobaric bupivacaine+15 µg fentanyl (1.3 ml),and Group B was administered a solution containing 7 mg isobaric bupivacaine+15 µg fentanyl (1.7ml).Hypotension,bradycardia,duration of analgesia,postoperative nausea and vomiting were recorded.

Official Title
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Comparison Of The Effects Of Two Different Low-Doses Of Isobaric Bupivacaine On Intraoperative Hemodynamics In Spinal Anesthesia During Cesarean Section: A Randomized Controlled Trial

Conditions
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Cesarean Section, Hemodynamic Instability

Intervention / Treatment
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* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria ASA I-II Pregnant women 18-50 years of age BMI<40kg/m2 150-180 cm in height Exclusion Criteria: Patients with hypertension induced by emergency obstetric surgery Significant systemic disease, Multiple pregnancies, Fetal or placental abnormality, Hypersensitivity or allergy history to the drugs to be used in the study Contraindicated neuraxial anesthesia, Infection at or around the region to be anesthetized, Coagulation abnormalities Patients unable to decide or unwilling to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group İzobarik bupivakain (5 mg) + fentanil<br>Patients were given a solution containing 5 mg isobaric bupivacaine + 15 µg fentanyl (1.3 ml) | Drug: Bupivacaine<br>* Two Different Low-Doses Of Isobaric Bupivacaine ( Group İzobarik bupivakain (5 mg) + fentanil and Group İzobarik bupivakain (7 mg)+ fentanyl ) were administered to the subarachnoid space<br>|
| Active Comparator: Group İzobarik bupivakain (7 mg) + fentanil<br>Patients were givena solution containing 7 mg isobaric bupivacaine + 15 µg fentanyl (1.7 ml) | Drug: Bupivacaine<br>* Two Different Low-Doses Of Isobaric Bupivacaine ( Group İzobarik bupivakain (5 mg) + fentanil and Group İzobarik bupivakain (7 mg)+ fentanyl ) were administered to the subarachnoid space<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary aim of study was to compare the effects of two different low-dose bupivacaine used in spinal anesthesia on intraoperative systolic and diastolic blood pressure (mmHg) in cesarean section operations. | Intraoperatif hemodynamics | during cesarean procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ceseaean section, Spinal anesthesia, Hemodynamics