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

Sponsor
Ataturk University (Other)
Overall Status
Completed
CT.gov ID
NCT05136040
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
8
Actual Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Oct 15, 2018
Actual Primary Completion Date :
Jun 15, 2019
Actual Study Completion Date :
Jun 15, 2019

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Group İzobarik bupivakain (5 mg) + fentanil

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

Drug: Bupivacaine
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

Active Comparator: Group İzobarik bupivakain (7 mg) + fentanil

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

Drug: Bupivacaine
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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Aysenur DostbilYakutiyeErzurumTurkey25000

Sponsors and Collaborators

  • Ataturk University

Investigators

  • Study Director: Mehmet Aksoy, MD, Ataturk University, Department of Anesthesiology and Reanimation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aysenur Dostbil, Principal Investigator, Ataturk University
ClinicalTrials.gov Identifier:
NCT05136040
Other Study ID Numbers:
  • B.30.2.ATA.0.01.00
First Posted:
Nov 26, 2021
Last Update Posted:
Dec 8, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aysenur Dostbil, Principal Investigator, Ataturk University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 8, 2021