Insomnia and Wake up and Recovery From Anesthesia
observational
80
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2017
Typical duration for all trials
1 active site
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
December 4, 2017
CompletedFirst Submitted
Initial submission to the registry
October 3, 2019
CompletedFirst Posted
Study publicly available on registry
October 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2021
CompletedMay 4, 2021
May 1, 2021
3.1 years
October 3, 2019
May 2, 2021
Conditions
Keywords
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
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)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tuna Şahin
Adana City Training and Research Hospital
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