Insomnia and Wake up and Recovery From Anesthesia

Sponsor
Adana City Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04119531
Collaborator
(none)
80
1
37.9
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Insomnia and Wake up and Recovery From Anesthesia
    Actual Study Start Date :
    Dec 4, 2017
    Actual Primary Completion Date :
    Dec 30, 2020
    Actual Study Completion Date :
    Jan 30, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Time of eye opening [up to 15 minutes]

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

    2. Time of transpher to the postoperative care unit [up to 25 minutes]

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

    3. Recovery scores [during 1 hour at postoperative period]

      Modified Aldrete Recovery Score

    Secondary Outcome Measures

    1. Pain scores [during 1 hour at postoperative period]

      Visual analogue scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 18- 55 years

    • ASA 1-2 patients

    • Patients undergoing elective ureteroscopy

    Exclusion Criteria:
    • Renal failure

    • Obstructive Sleep Apnea Syndrome,

    • Thyroid dysfunction

    • Neurologic and physiatric dysfunctions,

    • Morbid obesity

    • Anticonvulsant, antidepressant, anxiolytic drugs usage

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tuna Şahin Adana Turkey

    Sponsors and Collaborators

    • Adana City Training and Research Hospital

    Investigators

    • Principal Investigator: Tuna Şahin, Adana City Training and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tuna Şahin, Specialist of Anesthesiology and Reanimation, Adana City Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT04119531
    Other Study ID Numbers:
      First Posted:
      Oct 8, 2019
      Last Update Posted:
      May 4, 2021
      Last Verified:
      May 1, 2021
      Individual Participant Data (IPD) Sharing Statement:
      No
      Plan to Share IPD:
      No
      Studies a U.S. FDA-regulated Drug Product:
      No
      Studies a U.S. FDA-regulated Device Product:
      No
      Keywords provided by Tuna Şahin, Specialist of Anesthesiology and Reanimation, Adana City Training and Research Hospital
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of May 4, 2021