Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000943246
Ethics application status
Approved
Date submitted
19/05/2018
Date registered
4/06/2018
Date last updated
4/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of general anesthesia effects in normal weight and fat patients undergoing laparoscopic surgery
Scientific title
Comparison of general anesthesia effects in normal weight and obese patients undergoing laparoscopic surgery
Secondary ID [1] 294933 0
nil known
Universal Trial Number (UTN)
U1111-1214-3174
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
laparoscopic cholecystectomy 307902 0
obesity 307903 0
Condition category
Condition code
Anaesthesiology 306942 306942 0 0
Other anaesthesiology
Surgery 306943 306943 0 0
Other surgery
Respiratory 307061 307061 0 0
Other respiratory disorders / diseases
Diet and Nutrition 307133 307133 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will be using the same brand anesthesia device (dräger perseus A500) and the same brand sodalime.
We will perform monitorization (Electrocardiography, SpO2, noninvasive systolic diastolic blood pressure) in our normal routine protocol before the surgery.
2-3 mg / kg propofol, 1-2 µg / kg fentanyl, 0.6 mg / kg rocuronium , 1 mg/kg lidocaine will be administered intravenously during induction of anesthesia. After 2 minutes the patient will be intubated. We will use desflurane as inhaler anesthetic; nitrogen protoxide will not be used.
ARM1: NORMAL WEIGHT, LOW FLOW GROUP. The fresh gas flow will be adjusted to 2 lt/ min (FiO2: 80%), desflurane 12% until the minimum alveolar concentration (MAC) reached to 1 after intubation in normal weight patients (body mass index greater than or equal to 18 and less than 25) . After reaching MAC 1, fresh gas flow will be decreased to 0,5 lt/min and desflurane will be adjusted as MAC 1. FiO2 will continue as 80%. 15 minutes ago before the surgery has finished, we will close desflurane.
ARM2: OBESE, LOW FLOW GROUP. The fresh gas flow will be adjusted to 2 lt/ min (FiO2: 80%), desflurane 12% until the minimum alveolar concentration (MAC) reached to 1 after intubation in obese patients (body mass index greater than or equal to 30) . After reaching MAC 1, fresh gas flow will be decreased to 0,5 lt/min and desflurane will be adjusted as MAC 1. FiO2 will continue as 80%. 15 minutes ago before the surgery has finished, we will close desflurane.
ARM3: NORMAL WEIGHT, HIGH FLOW GROUP. The fresh gas flow will be adjusted to 2 lt/ min (FiO2: 50%), desflurane 12% until the minimum alveolar concentration (MAC) reached to 1 after intubation in normal weight patients. After reaching MAC 1, the fresh gas flow will continue at 2 lt/min (FiO2:50%) and desflurane will be adjusted as MAC 1.
ARM4: OBESE, HIGH FLOW GROUP. The fresh gas flow will be adjusted to 2 lt/ min (FiO2: 50%), desflurane 12% until the minimum alveolar concentration (MAC) reached to 1 after intubation in obese patients. After reaching MAC 1, the fresh gas flow will continue at 2 lt/min (FiO2:50%) and desflurane will be adjusted as MAC 1.
All patients will be followed by an experienced anesthesiologist for at least 4 years.
The mean duration of surgery is 60 minutes.
Intervention code [1] 301253 0
Treatment: Devices
Comparator / control treatment
We select the high flow group as control group so arm3 and arm4 are our control group. In our country we use high flow anesthesia routinely.
ARM3: NORMAL WEIGHT, HIGH FLOW GROUP. The fresh gas flow will be adjusted to 2 lt/ min (FiO2: 50%), desflurane 12% until the minimum alveolar concentration (MAC) reached to 1 after intubation in normal weight patients. After reaching MAC 1, the fresh gas flow will continue at 2 lt/min (FiO2:50%) and desflurane will be adjusted as MAC 1.
ARM4: OBESE, HIGH FLOW GROUP. The fresh gas flow will be adjusted to 2 lt/ min (FiO2: 50%), desflurane 12% until the minimum alveolar concentration (MAC) reached to 1 after intubation in obese patients. After reaching MAC 1, the fresh gas flow will continue at 2 lt/min (FiO2:50%) and desflurane will be adjusted as MAC 1.
Control group
Active

Outcomes
Primary outcome [1] 305937 0
The amount of oxygen in the expiratory tidal volume assessed by the ventilator.

if the oxygen level decrease below the 30% in the expiratory tidal volume, the amount of oxygen presented will be increased.
Timepoint [1] 305937 0
every 5 minutes during the operation time
Secondary outcome [1] 347661 0
the amount of anesthetic gas used by the patient assessed by the ventilator.
Timepoint [1] 347661 0
after surgery when the anesthesia device is stand by.
Secondary outcome [2] 347662 0
the amount of anesthesia gas thrown out the environment assessed by the ventilator.
Timepoint [2] 347662 0
after surgery when the anesthesia device is stand by

Eligibility
Key inclusion criteria
patients who are undergoing laparoscopic cholecystectomy surgery
obese patients, normal weight patients
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
smokers, ASA 3-4 patients, overweight patients

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
50 obese patients and 50 normal patients will partake in the study. Half of them will undergo low flow anesthesia, half of them will undergo high flow anesthesia. We will decide the sealed opaque envelopes procedure to determine who will be in the low-flow anesthesia group, who will be in the high flow anesthesia group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The number of participants was determined by evaluating previous studies.
The data will be analyzed with SPSS for Windows version 23.0. Mean, standard deviation in descriptive statistics of continuous variables; categorical variables will be expressed in numbers and percentages. The significance of the difference between groups for categorical variables will be evaluated by Chi-square test. Student's t-test was used for normal distribution in the binary group comparisons, Mann Whitney-U test in the non-normal range, and Krukall Wallis test and Bonferoni correction in more than one group. Correlation of continuous variables will be assessed by Pearson Rho correlation in normal scattering data and Spearman correlation test in normal scattering. A value of p <0.05 will be considered statistically significant

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/06/2018
Actual
Date of last participant enrolment
Anticipated
3/09/2018
Actual
Date of last data collection
Anticipated
3/09/2018
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 10411 0
Turkey
State/province [1] 10411 0
SANLIURFA

Funding & Sponsors
Funding source category [1] 299518 0
Self funded/Unfunded
Name [1] 299518 0
Country [1] 299518 0
Primary sponsor type
Individual
Name
Mehmet Tercan.
Address
Health Sciences University Sanliurfa Mehmet Akif Inan Education Research Hospital, Ertugrul Street, Esentepe 63300, Haliliye, Sanliurfa, Turkey
Country
Turkey
Secondary sponsor category [1] 298816 0
Individual
Name [1] 298816 0
Ayse Güsün Halitoglu
Address [1] 298816 0
Health Sciences University Sanliurfa Mehmet Akif Inan Education Research Hospital, Ertugrul Street, Esentepe 63300, Haliliye, Sanliurfa, Turkey
Country [1] 298816 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300414 0
Harran University medical faculty ethics committee
Ethics committee address [1] 300414 0
Ethics committee country [1] 300414 0
Turkey
Date submitted for ethics approval [1] 300414 0
27/04/2018
Approval date [1] 300414 0
18/05/2018
Ethics approval number [1] 300414 0
74059997-050.04.04

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83586 0
Dr Mehmet Tercan
Address 83586 0
Health Sciences University Sanliurfa Mehmet Akif Inan Education Research Hospital, Ertugrul Street, Esentepe 63300, Haliliye, Sanliurfa, Turkey
Country 83586 0
Turkey
Phone 83586 0
+905323445635
Fax 83586 0
Email 83586 0
[email protected]
Contact person for public queries
Name 83587 0
Mehmet Tercan
Address 83587 0
Health Sciences University Sanliurfa Mehmet Akif Inan Education Research Hospital, Ertugrul Street, Esentepe 63300, Haliliye, Sanliurfa, Turkey
Country 83587 0
Turkey
Phone 83587 0
+905323445635
Fax 83587 0
Email 83587 0
[email protected]
Contact person for scientific queries
Name 83588 0
Mehmet Tercan
Address 83588 0
Health Sciences University Sanliurfa Mehmet Akif Inan Education Research Hospital, Ertugrul Street, Esentepe 63300, Haliliye, Sanliurfa, Turkey
Country 83588 0
Turkey
Phone 83588 0
+905323445635
Fax 83588 0
Email 83588 0
[email protected]

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

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