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

NCT05136040 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section; Hemodynamic Instability

Keywords

Ceseaean section; Spinal anesthesia; Hemodynamics

Outcome Measures

Primary Outcomes (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.

  Intraoperatif hemodynamics

  during cesarean procedure

Study Arms (2)

Group İzobarik bupivakain (5 mg) + fentanil

ACTIVE COMPARATOR

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

Drug: Bupivacaine

Group İzobarik bupivakain (7 mg) + fentanil

ACTIVE COMPARATOR

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

Drug: Bupivacaine

Interventions

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

Group İzobarik bupivakain (5 mg) + fentanil; Group İzobarik bupivakain (7 mg) + fentanil

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I-II
• Pregnant women
• years of age
• BMI\<40kg/m2
• cm in height

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Aysenur Dostbil

Yakutiye, Erzurum, 25000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mehmet Aksoy, MD

  Ataturk University, Department of Anesthesiology and Reanimation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 26, 2021
• Study Start: October 15, 2018
• Primary Completion: June 15, 2019
• Study Completion: June 15, 2019
• Last Updated: December 8, 2021

Record last verified: 2021-11

Locations

TU (1)