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Clinical Trials/NCT05136040
NCT05136040
Completed
Not Applicable

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

Ataturk University1 site in 1 country80 target enrollmentOctober 15, 2018

Overview

Phase
Not Applicable
Intervention
Bupivacaine
Conditions
Cesarean Section
Sponsor
Ataturk University
Enrollment
80
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2018
End Date
June 15, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Aysenur Dostbil

Principal Investigator

Ataturk University

Eligibility Criteria

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

Arms & Interventions

Group İzobarik bupivakain (5 mg) + fentanil

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

Intervention: Bupivacaine

Group İzobarik bupivakain (7 mg) + fentanil

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

Intervention: Bupivacaine

Outcomes

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

Study Sites (1)

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