NCT05624671

Brief Summary

It is to predict postspinal hypotension that may develop in patients diagnosed with overactive bladder who will undergo elective cesarean section under spinal-epidural anesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 22, 2022

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

2.4 years

First QC Date

September 23, 2022

Last Update Submit

November 18, 2022

Conditions

18-45 Range of AgeCesarean SectionPrimigravid

Keywords

cesarean sectionspinal-epiduraloveractive bladderpost-spinal hypotension

Outcome Measures

Primary Outcomes (1)

  • Is Elective Caesarean Sections for Predicting Post-spinal Hypotension (reduction of systolic blood pressure(mmHg) after spinal anesthesia) Role of Overactive Bladder?

    It is to predict postspinal hypotension (systolic blood pressure below 20% of the basal value) that may develop in patients diagnosed with overactive bladder who will undergo elective cesarean section under spinal-epidural anesthesia.

    Intraoperative period

Study Arms (1)

IS THERE ANY ROLE OF OVERACTIVE BLADDER IN POSTSPINAL HYPOTENSION IN ELECTIVE CAESAREAN SECTIONS?

OTHER

According to our institution protocol, intravenous (iv) hydration will not be given as preload and afterload and vasopressor infusion will not be initiated before spinal anesthesia. After the skin is prepared sterile and local infiltration with 2% lidocaine is done, from L3-L4 OR L4-L5 range on midline with the 16 gauge Tuohy needle and the loss of resistance technique epidural space is identified and then 26 gauge pencil point needle is passed trough the Touhy and the dura will be drilled. After the cerebrospinal fluid (CSF) is seen the fluid containing 5mg isobaric bupivacaine and 15µg fentanyl will be given in 30 seconds to patients. After the spinal needle is removed, the epidural catheter is placed 3-5 cm in the epidural space through Tuohy, and after the catheter is fixated, the patients will be placed in the supine position by placing a height under their right hip with a 15 ° angle.

Other: bupivacaine,fentanyl

Interventions

bupivacaine,fentanylOTHER

According to our institution protocol, intravenous (iv) hydration will not be given as preload and afterload and vasopressor infusion will not be initiated before spinal anesthesia. After the skin is prepared sterile and local infiltration with 2% lidocaine is done, from L3-L4 OR L4-L5 range on midline with the 16 gauge Tuohy needle and the loss of resistance technique epidural space is identified and then 26 gauge pencil point needle is passed trough the Touhy and the dura will be drilled. After the cerebrospinal fluid (CSF) is seen the fluid containing 5mg isobaric bupivacaine and 15µg fentanyl will be given in 30 seconds to patients. After the spinal needle is removed, the epidural catheter is placed 3-5 cm in the epidural space through Tuohy, and after the catheter is fixated, the patients will be placed in the supine position by placing a height under their right hip with a 15 ° angle.

IS THERE ANY ROLE OF OVERACTIVE BLADDER IN POSTSPINAL HYPOTENSION IN ELECTIVE CAESAREAN SECTIONS?

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I-II
  • Primigravid
  • Elective cesarean sections

You may not qualify if:

  • ≤18 age
  • ≥45 age
  • Emergency surgery
  • Pregnancy-induced hypertension,
  • Significant systemic disease,
  • Multiple pregnancy,
  • Fetal or placental abnormality,
  • History of hypersensitivity or allergy to drugs to be used in the study,
  • Morbidly obese (BMI≥40),
  • Patients for whom neuraxial anesthesia is contraindicated,
  • Unable or unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

BupivacaineFentanyl

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • AYŞENUR DOSTBİL

    Ataturk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

September 23, 2022

First Posted

November 22, 2022

Study Start

August 1, 2019

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

November 22, 2022

Record last verified: 2022-11

Locations

TU(1)