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

Ataturk University

Status: Completed

Conditions: Cesarean Section; Hemodynamic Instability

Treatments: Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05136040

B.30.2.ATA.0.01.00

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Group İzobarik bupivakain (5 mg) + fentanil

Active Comparator group

Description:

Patients were given a solution containing 5 mg isobaric bupivacaine + 15 µg fentanyl (1.3 ml)

Treatment:

Drug: Bupivacaine

Group İzobarik bupivakain (7 mg) + fentanil

Active Comparator group

Description:

Patients were givena solution containing 7 mg isobaric bupivacaine + 15 µg fentanyl (1.7 ml)

Treatment:

Drug: Bupivacaine