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

Not Applicable

Completed

• Conditions: Hemodynamic Instability; Cesarean Section
• Interventions: Drug: Bupivacaine

• Registration Number: NCT05136040
• Lead Sponsor: Ataturk University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-15
• Primary Completion: 2019-06-15
• Study Completion: 2019-06-15
• Study First Submitted: 2021-10-21
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-24
• Last Update Submitted: 2021-11-25
• Study First Posted: 2021-11-26
• Last Update Posted: 2021-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group İzobarik bupivakain (5 mg) + fentanil	Bupivacaine	Patients were given a solution containing 5 mg isobaric bupivacaine + 15 µg fentanyl (1.3 ml)
Group İzobarik bupivakain (7 mg) + fentanil	Bupivacaine	Patients were givena solution containing 7 mg isobaric bupivacaine + 15 µg fentanyl (1.7 ml)

Primary Outcome Measures

Name	Time	Method
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.	during cesarean procedure	Intraoperatif hemodynamics

Trial Locations

Locations (1)

Aysenur Dostbil; 🇹🇷 Yakutiye, Erzurum, Turkey