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

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.

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Key information

Conditions

Cesarean Section Hemodynamic Instability

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aysenur Dostbil

Yakutiye, Erzurum, 25000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Bupivacaine

Drug

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

Primary outcomes

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.

Time frame: during cesarean procedure

Intraoperatif hemodynamics

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study 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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Nov 26, 2021
Registry last updated: Dec 8, 2021

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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