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Trial registered on ANZCTR


Registration number
ACTRN12622001388707
Ethics application status
Approved
Date submitted
19/07/2022
Date registered
28/10/2022
Date last updated
28/10/2022
Date data sharing statement initially provided
28/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of dexmedetomidine and midazolam premedication in patients undergoing laparoscopic cholecystectomy: a prospective, randomised, dobule-blinded study
Scientific title
The effect of dexmedetomidine and midazolam premedication in patients undergoing laparoscopic cholecystectomy on stress hormone response: a prospective, randomised, double-blinded study
Secondary ID [1] 307598 0
Nil known
Universal Trial Number (UTN)
Trial acronym
StressDEMO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laparoscopic cholecystectomy 327041 0
Pre-operative anxiety 327090 0
Condition category
Condition code
Anaesthesiology 324213 324213 0 0
Anaesthetics
Surgery 324214 324214 0 0
Other surgery
Oral and Gastrointestinal 324215 324215 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology 324216 324216 0 0
Pain management
Mental Health 324217 324217 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention undertaken will be one application of 0.3 mcg/kg of dexmedetomidine in 100 mL of saline infused over 20 minutes (Subject group) as a premedication for patients undergoing elective laparoscopic cholecystectomy. Premedication will be applied by attending anaesthesiologists in a University Hospital Centre PACU. Adherence to intervention will be monitored using study data collection chart.
Intervention code [1] 324047 0
Treatment: Drugs
Intervention code [2] 324048 0
Prevention
Comparator / control treatment
Control group is the group receiving one dose of midazolam 0.03 mg/kg in 100 mL of saline over 20 minutes 1 hour before elective laparoscopic cholecystectomy. It is standard premedication in our University Hospital Centre and will be applied by an attending anaesthesiologist in PACU with standard patient monitoring (SpO2, noninvasive blood pressure, ECG). Adherence will be monitored using study data collection chart.
Control group
Active

Outcomes
Primary outcome [1] 332034 0
Plasma ACTH level
Timepoint [1] 332034 0
Peripheral blood sample drawn 15 minutes before premedication as a primary time point, Other timepoints are 5 minutes before anaesthesia induction and 2 hours after the procedure.
Primary outcome [2] 332035 0
Noninvasive blood pressure measured using an automated sphygmomanometer. Primary timepoint is before premedication. Other timepoints are before anaesthesia induction and after the procedure. Values taken are mean of 3 measurements.
Timepoint [2] 332035 0
Measured using an automated sphygmomanometer. Primary timepoint is 15 minutes before premedication. Other timepoints are 10 minutes before anaesthesia induction and 2 hours after the procedure. Values taken are mean of 3 measurements in 3 minute time window.
Primary outcome [3] 332036 0
Heart rate measured using a pulse oximeter. Primary timepoint is before premedication. Other timepoints are before anaesthesia induction and after the procedure. Values taken are mean of 3 measurements.
Timepoint [3] 332036 0
Measured using a pulse oximeter. Primary timepoint is 15 minutes before premedication. Other timepoints are 10 minutes before anaesthesia induction and 2 hours after the procedure. Values taken are mean of 3 measurements in 3 minute time window.
Secondary outcome [1] 411966 0
Numeric pain rating score (NPRS)
Timepoint [1] 411966 0
Noted 2, 4, 6, 8, 10 and 12 hours after the procedure.
Secondary outcome [2] 411967 0
Occurrence of side-effects: dizziness, tinnitus, tremor, nausea, vomiting's) will be recorded on a study specific questionnaire, self-reported by the participant. Data will be binary (yes/no).
Timepoint [2] 411967 0
Any timepoint between premedication and PACU (2 hours after the procedure)
Secondary outcome [3] 412970 0
Neutrophil/lymphocyte ratio. Measured from a drawn peripheral blood sample before premedication (primary outcome) and after the procedure.
Timepoint [3] 412970 0
Measured from a drawn peripheral blood sample 15 minutes before premedication (primary timepoint) and 6 hours after the procedure.
Secondary outcome [4] 412971 0
Total dose of opioid used, morphium equivalent. Dose noted will be a sum of all opioid used during the procedure and during the patient observation in PACU (standard 2 hours after the procedure), converted to morphium equivalent. Doses are noted on standard institution anesthesia charts.
Timepoint [4] 412971 0
Any timepoint between premedication and PACU (2 hours after the procedure). Doses are noted on standard institution anesthesia charts.
Secondary outcome [5] 412972 0
Total dose of propofol used for induction. Doses are noted on standard institution anesthesia charts.
Timepoint [5] 412972 0
Total dose of propofol used for the induction of anaesthesia for the procedure. Doses are noted on standard institution anesthesia charts.
Secondary outcome [6] 412973 0
Total dose of ephedrine used during the procedure. Doses are noted on standard institution anesthesia charts.
Timepoint [6] 412973 0
Any timepoint between premedication and PACU (2 hours after the procedure). Doses are noted on standard institution anesthesia charts.
Secondary outcome [7] 415328 0
HAD anxiety and depression scale
Timepoint [7] 415328 0
Taken anytime before premedication.

Eligibility
Key inclusion criteria
The inclusion criteria are: patients undergoing elective laparoscopic cholecystectomy, age (18-70 years) and ASA Physical status Classification I or II
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Body mass index <18 or > 30, Allergy to any of the drugs used, prolonged QT interval, patients with psychiatric diagnoses, patients taking medication that may interfere with ACTH levels (corticosteroids, androgens and estrogens)

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)
Allocation will be done by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
A priory power analysis for t-test at effect size 0.5 and alpha 0.05, has shown that 32 subjects are sufficient to achieve power of 0.8. To comply with the law of large numbers statistical, theorem we plan on recruiting 30 subjects per group and consider it a sufficient sample size to comply with both criteria. Data will be stored in Excel datasheet and processed using SPSS statistical software.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2022
Actual
Date of last participant enrolment
Anticipated
26/02/2023
Actual
Date of last data collection
Anticipated
2/03/2023
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 24899 0
Croatia
State/province [1] 24899 0
Zagreb

Funding & Sponsors
Funding source category [1] 311868 0
Hospital
Name [1] 311868 0
Department of Anestesiology, Intesive Care Medicine and Pain Managment of the Clinical Hospital Center of "Sister of Mercy" Zagreb
Country [1] 311868 0
Croatia
Funding source category [2] 311871 0
University
Name [2] 311871 0
University of Split, Faculty of Medicine, Service of science, postgraduate studies and international cooperation
Country [2] 311871 0
Croatia
Primary sponsor type
Hospital
Name
Department of Anestesiology, Intesive Care Medicine and Pain Managment of the Clinical Hospital Center of "Sister of Mercy" Zagreb
Address
Vinogradska cesta 29, 10000 Zagreb, Croatia
Country
Croatia
Secondary sponsor category [1] 313342 0
None
Name [1] 313342 0
Address [1] 313342 0
Country [1] 313342 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311305 0
Sektor pravnih, kadrovskih i opcih poslova Klinicki bilnicki centar "Sestre milosrdnice"
Ethics committee address [1] 311305 0
Vinogradska cesta 29, 10000 Zgreb
Ethics committee country [1] 311305 0
Croatia
Date submitted for ethics approval [1] 311305 0
18/07/2022
Approval date [1] 311305 0
08/09/2022
Ethics approval number [1] 311305 0
251-29-11-22-08

Summary
Brief summary
The goal of this study is to determine if (H1) dexmedetomidine and midazolam are equally effective in reducing anxiety and stress response of surgical patients for elective cholecystectomy. 60 patients aged between 18 and 70, of ASA status I and II and BMI between 18 and 30 will be randomly allocated into dexmedetomidine and midazolam premedication group. Primary outcome will be a comparison of plasma ACTH level. Secondary outcomes will be a comparison of perioperative hemodynamic data, neutrphil/lymphocyte ratio, NPRS scores, and amount of drugs (opioids, induction agents, ephedrine) used.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120642 0
Dr Antonija Vuletic Brletic
Address 120642 0
University hospital centre Sestre Milosrdnice
Vinogradska cesta 29
10000 Zagreb
Croatia
Country 120642 0
Croatia
Phone 120642 0
+385981784063
Fax 120642 0
Email 120642 0
antonija.vule1@gmail.com
Contact person for public queries
Name 120643 0
Dr Tomislav Radocaj
Address 120643 0
University hospital centre Sestre Milosrdnice
Vinogradska cesta 29
10000 Zagreb
Croatia
Country 120643 0
Croatia
Phone 120643 0
+385911262586
Fax 120643 0
Email 120643 0
tomislav.radocaj@kbcsm.hr
Contact person for scientific queries
Name 120644 0
Dr Lada Lijovic
Address 120644 0
University hospital centre Sestre Milosrdnice
Vinogradska cesta 29
10000 Zagreb
Croatia
Country 120644 0
Croatia
Phone 120644 0
+385958950935
Fax 120644 0
Email 120644 0
lada.lijovic@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Age, sex, ASA status and BMI, heart rate, noninvasive blood pressure, NPRS scale, HAD scale, complete blood count, plasmatic ACTH, hemodynamic data, total ephedrine dose used, total amount of propofol and sufentanil used during the procedure, occurrence of adverse effects.
When will data be available (start and end dates)?
Immediately after first publication and ending 3 years following main results publication.
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by principal investigator, please contact by e-mail address (antonija.vuletic@kbcsm.hr or antonija.vule1@gmail.com)


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
No additional documents have been identified.