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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.
Scientific title
Effect of insomnia on anaesthetic requirement in patients undergoing laparoscopic cholecystectomy.
Secondary ID [1] 288519 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
insomnia
297594 0
laparoscopic cholecystectomy 297681 0
Condition category
Condition code
Anaesthesiology 297790 297790 0 0
Anaesthetics
Mental Health 297791 297791 0 0
Other mental health disorders
Oral and Gastrointestinal 297857 297857 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 293881 0
Treatment: Drugs
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.
Control group
Active

Outcomes
Primary outcome [1] 297316 0
anesthetic requirement is assessed by review of hospital anesthesia records.
Timepoint [1] 297316 0
from start of procedure to end of the procedure.
Secondary outcome [1] 320707 0
post-operative pain assessment by Numerical Rating Scale (NRS; 0-10).
Timepoint [1] 320707 0
2, 4, 8, 12, 18 hours postoperatively.

Eligibility
Key inclusion criteria
Inpatients planning to undergo laparoscopic cholecystectomy as an elective surgery
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
renal failure, thyroid dysfunction, morbid obesity, obstructive sleep apnea,
neurological dysfunction, alcoholism, anticonvulsants and opioids usage

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7582 0
Turkey
State/province [1] 7582 0
Istanbul

Funding & Sponsors
Funding source category [1] 292864 0
Self funded/Unfunded
Name [1] 292864 0
unfunded
Address [1] 292864 0
unfunded
Country [1] 292864 0
Primary sponsor type
Individual
Name
VEYSEL ERDEN
Address
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Country
Turkey
Secondary sponsor category [1] 291610 0
None
Name [1] 291610 0
none
Address [1] 291610 0
none
Country [1] 291610 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294365 0
Istanbul Training and Research Hospital
Ethics committee address [1] 294365 0
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Ethics committee country [1] 294365 0
Turkey
Date submitted for ethics approval [1] 294365 0
27/11/2015
Approval date [1] 294365 0
11/12/2015
Ethics approval number [1] 294365 0
235687

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63458 0
A/Prof VEYSEL ERDEN
Address 63458 0
ISTANBUL TRAINING and RESEARCH HOSPITAL
Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH
Country 63458 0
Turkey
Phone 63458 0
+90 212 459 60 50
Fax 63458 0
Email 63458 0
v_erden@hotmail.com
Contact person for public queries
Name 63459 0
Dr CIHAN GULER
Address 63459 0
ISTANBUL TRAINING and RESEARCH HOSPITAL
Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH
Country 63459 0
Turkey
Phone 63459 0
+90 212 459 61 63
Fax 63459 0
Email 63459 0
cianguler@gmail.com
Contact person for scientific queries
Name 63460 0
Dr CIHAN GULER
Address 63460 0
ISTANBUL TRAINING and RESEARCH HOSPITAL
Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH
Country 63460 0
Turkey
Phone 63460 0
+90 212 459 61 63
Fax 63460 0
Email 63460 0
cianguler@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary