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)

Enrollment

Location

Arms

Actual Duration (Months)

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 Disease	Intervention/Treatment	Phase
Cesarean Section Hemodynamic Instability	Drug: Bupivacaine	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

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

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

Outcome Measures

Primary Outcome Measures

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

	Site	City	State	Country	Postal Code
1	Aysenur Dostbil	Yakutiye	Erzurum	Turkey	25000

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:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Aysenur Dostbil, Principal Investigator, Ataturk University

Ceseaean section

Spinal anesthesia

Hemodynamics

Additional relevant MeSH terms:

Bupivacaine

Study Results

No Results Posted as of Dec 8, 2021