Insomnia and Wake up and Recovery From Anesthesia

Insomnia Clinical Trial

Official title:

Insomnia and Wake up and Recovery From Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119531
• Status: Completed
• Start date: December 4, 2017
• Est. completion date: January 30, 2021

Study information

• Verified date: May 2021
• Source: Adana City Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 30, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Locations

Country	Name	City	State
Turkey	Tuna Sahin	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Adana City Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Recovery scores	Modified Aldrete Recovery Score	during 1 hour at postoperative period
Secondary	Pain scores	Visual analogue scale	during 1 hour at postoperative period