NCT03958578

Brief Summary

Spinal anaesthesia results in blockade of sympathetic efferent neurones. Patients with higher baseline sympathetic activation have been shown to have more marked hypotension after spinal anaesthesia. Anxiety causes generalized sympathetic activation. It was aimed to find the effect of preoperative anxiety on the duration and efficacy of neuraxial anaesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

May 20, 2019

Last Update Submit

November 22, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • State-Trait Anxiety Inventory questionnaire

    State-Trait Anxiety Inventory questionnaire is a direct psychological assessment of preoperative anxiety.

    20-30 minutes.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

It is planned to enroll healthy individuals undergoing elective surgery under spinal anaesthesia.

You may qualify if:

  • Patients aged between 18 and 55 years.
  • ASA I-II
  • BMI 18-25

You may not qualify if:

  • Major surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yadigar Yılmaz

Istanbul, 34230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

May 20, 2019

First Posted

May 22, 2019

Study Start

May 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations