NCT04119531

Brief Summary

18-55 years old 100 patients, who are planned to undergo for planned ureteroscopy will be participated in the study. In the preoperative room patients will be asked to participate to the study. If they accept 4 item Jenkins-Sleep Questionaire will be asked to them.Patients will be divided to two groups , with or without insomnia according to their answers to the questionaire. General anesthesia will be performed to all patients. At the end of operation anesthesia time,operation time, time of eye opening, time of transfer to the recovery room will be recorded in the operating room. Pain scores and recovery scores will be evaluated in the recovery room.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 8, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

May 4, 2021

Status Verified

May 1, 2021

Enrollment Period

3.1 years

First QC Date

October 3, 2019

Last Update Submit

May 2, 2021

Conditions

Keywords

anesthesiarecoveryinsomnia

Outcome Measures

Primary Outcomes (3)

  • Time of eye opening

    from the time anesthesia was discontinued and neuromuscular blockage was reversed to the time of eye opening

    up to 15 minutes

  • Time of transpher to the postoperative care unit

    from the time anesthesia was discontinued and neuromuscular blockage was reversed to the time of transpher to the postoperative care unit

    up to 25 minutes

  • Recovery scores

    Modified Aldrete Recovery Score

    during 1 hour at postoperative period

Secondary Outcomes (1)

  • Pain scores

    during 1 hour at postoperative period

Study Arms (2)

Patients with insomnia

In the preoperative room patients will be asked to participate to the study and will be asked to answer the 4-item Jenkins-Sleep Questionaire.If they accept to participate, written informed consent will be taken from the patients. According to their answers to the questionaire , patients will be divided into two groups :those with or without insomnia.

Patients without insomnia

In the preoperative room patients will be asked to participate to the study and will be asked to answer the 4-item Jenkins-Sleep Questionaire.If they accept to participate, written informed consent will be taken from the patients. According to their answers to the questionaire , patients will be divided into two groups :those with or without insomnia.

Eligibility Criteria

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

18-55 years old 100 patients with American Society of Anesthesiology (ASA) physical status I-II,who are planned to undergo for elective ureteroscopy will be participated in this study.

You may qualify if:

  • years
  • ASA 1-2 patients
  • Patients undergoing elective ureteroscopy

You may not qualify if:

  • Renal failure
  • Obstructive Sleep Apnea Syndrome,
  • Thyroid dysfunction
  • Neurologic and physiatric dysfunctions,
  • Morbid obesity
  • Anticonvulsant, antidepressant, anxiolytic drugs usage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuna Şahin

Adana, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Tuna Şahin

    Adana City Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist of Anesthesiology and Reanimation

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 8, 2019

Study Start

December 4, 2017

Primary Completion

December 30, 2020

Study Completion

January 30, 2021

Last Updated

May 4, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations