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

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ClinicalTrials.gov Identifier: NCT05136040
Recruitment Status : Completed
First Posted : November 26, 2021
Last Update Posted : December 8, 2021
Sponsor:
Information provided by (Responsible Party):
Aysenur Dostbil, 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.

Condition or disease Intervention/treatment Phase
Cesarean Section Hemodynamic Instability Drug: Bupivacaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : October 15, 2018
Actual Primary Completion Date : June 15, 2019
Actual Study Completion Date : June 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/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




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. [ Time Frame: during cesarean procedure ]
    Intraoperatif hemodynamics



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05136040


Locations
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Turkey
Aysenur Dostbil
Yakutiye, Erzurum, Turkey, 25000
Sponsors and Collaborators
Ataturk University
Investigators
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Study Director: Mehmet Aksoy, MD Ataturk University, Department of Anesthesiology and Reanimation
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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: November 26, 2021    Key Record Dates
Last Update Posted: December 8, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aysenur Dostbil, Ataturk University:
Ceseaean section
Spinal anesthesia
Hemodynamics
Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents