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Trial registered on ANZCTR
Registration number
ACTRN12616000241437
Ethics application status
Approved
Date submitted
11/02/2016
Date registered
22/02/2016
Date last updated
22/02/2016
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effect of insomnia on anaesthetic requirement in patients undergoing laparoscopic cholecystectomy.
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Scientific title
Effect of insomnia on anaesthetic requirement in patients undergoing laparoscopic cholecystectomy.
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Secondary ID [1]
288519
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nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
insomnia
297594
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laparoscopic cholecystectomy
297681
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Condition category
Condition code
Anaesthesiology
297790
297790
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0
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Anaesthetics
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Mental Health
297791
297791
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0
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Other mental health disorders
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Oral and Gastrointestinal
297857
297857
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The patients were divided into two groups by using the 4-item Jenkins Sleep Questionnaire(JSQ) due to degree of sleep disturbance . The 4 items were asked to the
patients: how frequent they had trouble falling asleep, woke up several times per night, had trouble staying asleep, feeling tired and worn out after the usual amount of sleep during the previous 4 weeks. There were six alternative responses: not at all (1), 1 to 3 days (2), 4 to 7 days (3), 8 to 14 days (4), 15 to 21 days (5) and 22 to 28 days (6). The patients having sleep problems occurring 4 or more times in previous 4 weeks were classified as insomnia group according to sleep disturbances. None of the patients were premedicated. The BIS sensor was applied to patients’ forehead and connected to digital signal converter before the induction of anesthesia. In all groups anesthesia was standardized and induced with propofol 2 mg/kg intravenously, muscle relaxation with rocuronium 0.5mg/kg intravenously. The fentanyl was given to all patients intravenously as a bolus 1 mcg/kg single dose intravenously before induction of anesthesia. Anesthesia was maintained with sevoflurane in a mixture of nitrous oxide 2L/min and oxygen 2L/min, during of procedure and all patients were mechanically ventilated to maintain an ETCO2 concentration of 30-37 mmHg. The BIS target range was maintained between 40-60 via administration of sevoflurane. No further fentanyl was given during operation. Inspiratory and end-tidal concentrations of sevoflurane and ETCO2 were measured. Heart rate, non-invasive arterial blood pressure, arterial oxygen saturation were also measured and recorded during the surgery. All measurements were recorded at 5- min intervals.
Pain was assessed in all participants preoperatively and postoperatively. Before the surgery; all participants who were asked about their pain experience lasting for 1 day or more in the past month. They also described their pain on a two-sided blank body manikin (front and back) and categorized into widespread pain, some pain or no pain. Widespread pain is described as pain presented in the both sides of the body, above and below the waist and in the axial skeleton. In cases which all criterias of widespread pain could not be satisfied, it was grouped as some pain. Postoperative abdominal pain was assessed by the patients themselves using numeric rating scale (NRS 0 = no pain, 10= worst possible pain), from 0 to 10 at 2, 4, 8, 12, 18 hours postoperatively. All assessment was done at rest. All patients in both groups were informed about how to use patient controlled intravenous analgesia (PCIA) self-control pump which was administered as soon as possible after the surgery ended. Each PCIA pump contained 300 mg tramadol dilution to 100 ml of 0.9 % saline solution and all of them were adjusted as 10 mg /h background dose and bolus dose of 10 mg, a locked out interval of 15 minutes.
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Intervention code [1]
293881
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Treatment: Drugs
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Comparator / control treatment
The 4 item Jenkins Sleep Questionnaire(JSQ) were asked to the
patients: how frequent they had trouble falling asleep, woke up several times per night, had trouble staying asleep, feeling tired and worn out after the usual amount of sleep during the previous 4 weeks. There were six alternative responses: not at all (1), 1 to 3 days (2), 4 to 7 days (3), 8 to 14 days (4), 15 to 21 days (5) and 22 to 28 days (6). Patients who responded “not at all” to all the items were classified as not having sleep problems and classified as control group.
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Control group
Active
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Outcomes
Primary outcome [1]
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anesthetic requirement is assessed by review of hospital anesthesia records.
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Assessment method [1]
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Timepoint [1]
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from start of procedure to end of the procedure.
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Secondary outcome [1]
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post-operative pain assessment by Numerical Rating Scale (NRS; 0-10).
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Assessment method [1]
320707
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Timepoint [1]
320707
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2, 4, 8, 12, 18 hours postoperatively.
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Eligibility
Key inclusion criteria
Inpatients planning to undergo laparoscopic cholecystectomy as an elective surgery
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
renal failure, thyroid dysfunction, morbid obesity, obstructive sleep apnea,
neurological dysfunction, alcoholism, anticonvulsants and opioids usage
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/06/2015
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Date of last participant enrolment
Anticipated
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Actual
31/12/2015
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
50
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Recruitment outside Australia
Country [1]
7582
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Turkey
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State/province [1]
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Istanbul
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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unfunded
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Address [1]
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unfunded
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Country [1]
292864
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Primary sponsor type
Individual
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Name
VEYSEL ERDEN
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Address
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
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Country
Turkey
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Secondary sponsor category [1]
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None
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Name [1]
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none
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Address [1]
291610
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none
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Country [1]
291610
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
294365
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Istanbul Training and Research Hospital
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Ethics committee address [1]
294365
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Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
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Ethics committee country [1]
294365
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Turkey
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Date submitted for ethics approval [1]
294365
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27/11/2015
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Approval date [1]
294365
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11/12/2015
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Ethics approval number [1]
294365
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235687
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Summary
Brief summary
There are several findings about gama-aminobutyric acid (GABA) which is the
primary inhibitory neurotransmitter in central nervous system and strongly related with the
etiology of chronic insomnia due to abnormal GABA content. GABA is also one of the
targets for general anesthetics. We planned to investigate whether the insomnia has any effect on anesthetic requirement.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof VEYSEL ERDEN
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Address
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ISTANBUL TRAINING and RESEARCH HOSPITAL
Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH
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Country
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Turkey
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Phone
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+90 212 459 60 50
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Fax
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Email
63458
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[email protected]
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Contact person for public queries
Name
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Dr CIHAN GULER
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Address
63459
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ISTANBUL TRAINING and RESEARCH HOSPITAL
Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH
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Country
63459
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Turkey
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Phone
63459
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+90 212 459 61 63
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Fax
63459
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Email
63459
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[email protected]
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Contact person for scientific queries
Name
63460
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Dr CIHAN GULER
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Address
63460
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ISTANBUL TRAINING and RESEARCH HOSPITAL
Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH
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Country
63460
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Turkey
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Phone
63460
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+90 212 459 61 63
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Fax
63460
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Email
63460
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Insomnia may increase anesthetic requirement.
2016
https://dx.doi.org/10.1016/j.jclinane.2016.05.020
N.B. These documents automatically identified may not have been verified by the study sponsor.
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