Skip to main content
OpenTrials
Completed

NCT Number: NCT04119531

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tuna Şahin

Adana, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time of eye opening

    Time frame: 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

    Time frame: 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

    Time frame: during 1 hour at postoperative period

    Modified Aldrete Recovery Score

Secondary outcomes

  1. Pain scores

    Time frame: during 1 hour at postoperative period

    Visual analogue scale

Sponsors and collaborators

Lead sponsor

Adana City Training and Research Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Oct 8, 2019
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.