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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05136040
• Other study ID #: B.30.2.ATA.0.01.00
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: June 15, 2019

Study information

• Verified date: November 2021
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 15, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Hemodynamic Instability

Intervention

Drug:
• Bupivacaine
Two Different Low-Doses Of Isobaric Bupivacaine ( Group Izobarik bupivakain (5 mg) + fentanil and Group Izobarik bupivakain (7 mg)+ fentanyl ) were administered to the subarachnoid space

Locations

Country	Name	City	State
Turkey	Aysenur Dostbil	Yakutiye	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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