Insomnia and Wake up and Recovery From Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Insomnia

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey
    • Tuna Şahin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	Visual analogue scale	during 1 hour at postoperative period

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 4, 2017
• Primary Completion (ACTUAL): December 30, 2020
• Study Completion (ACTUAL): January 30, 2021

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (ACTUAL): October 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 2, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: anesthesia; recovery; insomnia
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No