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CompletedNCT04119531Updated May 4, 2021

Insomnia and Wake up and Recovery From Anesthesia

An observational study in Insomnia, sponsored by Adana City Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-05-04.

Sponsored by Adana City Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the detailed description

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.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.General anesthesia will be performed to all patients. After anesthesia induction with propofol 2mg/kg and rocuronium 0.6 mg/kg, patients will be ıntubated and mechanically ventilated. Maintenance of anesthesia will be achieved with 4-6 % desflurane in nitrous oxide/ oxygen (50%/50%) concentrations with the flow 5L/min. Tramadol 1 mg/kg and metoclopramid 1 ampul will be administered intravenously after intubation. Hemodynamic parameters( systolic blood pressure, diastolic blood pressure, heart rate and peripheral oxygen saturation), end tidal carbon dioxide values, the concentrations of inspired and exhaled desflurane will be recorded on the surgery start time and on the 5th, 15th,25th,35th,45th,60 th minutes of surgery. At the end of operation ,neuromuscular blockage will be reversed with neostigmine (0,05 mg/kg)and atropine sulphate 0,015 mg/kg i.v. Anesthesia time, surgery time, time of eye opening,time of transfer to the recovery room will be recorded in the operating room. In the recovery room pain score will be evaluated with Visual Analogue Scale. Modified Aldrete Recovery Score will be used for evaluating recovery.

02

Conditions studied

  • Insomnia

Keywords

  • anesthesia
  • recovery
  • insomnia
03

In context

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

This study's enrollment of 80 is below the median of 128 across 191 observational studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Adana City Training and Research Hospital is the lead sponsor of 17 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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.

Inclusion criteria

  • 18- 55 years
  • ASA 1-2 patients
  • Patients undergoing elective ureteroscopy

Exclusion criteria

Exclusion Criteria:

  • Renal failure
  • Obstructive Sleep Apnea Syndrome,
  • Thyroid dysfunction
  • Neurologic and physiatric dysfunctions,
  • Morbid obesity
  • Anticonvulsant, antidepressant, anxiolytic drugs usage
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Time of eye opening

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

    Time frame: up to 15 minutes

  2. 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

    Time frame: up to 25 minutes

  3. Recovery scores

    Modified Aldrete Recovery Score

    Time frame: during 1 hour at postoperative period

Secondary outcomes

  1. Pain scores

    Visual analogue scale

    Time frame: during 1 hour at postoperative period

07

Study locations

1 site
  • Tuna Şahin
    Adana, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04119531
Lead sponsor
Adana City Training and Research Hospital
Responsible party
Tuna Şahin (Specialist of Anesthesiology and Reanimation, Adana City Training and Research Hospital) — Principal investigator
First posted
Oct 8, 2019
Start date
Dec 4, 2017
Primary completion
Dec 30, 2020
Completion
Jan 30, 2021
Last update
May 4, 2021

Study contacts

Tuna Şahin
principal investigator · Adana City Training and Research Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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