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

NCT ID: NCT05136040

Last Updated: 2021-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2019-06-15

Brief Summary

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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.

Detailed Description

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Conditions

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Cesarean Section Hemodynamic Instability

Keywords

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Ceseaean section Spinal anesthesia Hemodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group İzobarik bupivakain (5 mg) + fentanil

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type 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

Group İzobarik bupivakain (7 mg) + fentanil

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Aysenur Dostbil

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehmet Aksoy, MD

Role: STUDY_DIRECTOR

Ataturk University, Department of Anesthesiology and Reanimation

Locations

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Aysenur Dostbil

Yakutiye, Erzurum, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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B.30.2.ATA.0.01.00

Identifier Type: -

Identifier Source: org_study_id