Clinical trial NCT04119531: Insomnia and Wake up and Recovery From Anesthesia
Official title: Insomnia and Wake up and Recovery From Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insomnia
Keywords: anesthesia
recovery
insomnia
Lead sponsor: Adana City Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time of eye opening
timeFrame: up to 15 minutes
measure: Time of transpher to the postoperative care unit
timeFrame: up to 25 minutes
measure: Recovery scores
timeFrame: during 1 hour at postoperative period
Secondary outcomes:
measure: Pain scores
timeFrame: during 1 hour at postoperative period
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Tuna Şahin
Study officials:
affiliation: Adana City Training and Research Hospital
name: Tuna Şahin
role: PRINCIPAL_INVESTIGATOR
References: