Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000539639
Ethics application status
Approved
Date submitted
25/12/2022
Date registered
22/05/2023
Date last updated
22/05/2023
Date data sharing statement initially provided
22/05/2023
Date results information initially provided
22/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Managing haemodynamics during conduct of electroconvulsive therapy under general Anaesthesia
Scientific title
Comparison of Pretreatment with Dexmedetomidine and Metoprolol on Attenuation of Hemodynamic Parameters and Emergence during Electroconvulsive Therapy
Secondary ID [1] 308673 0
Nil known
Universal Trial Number (UTN)
U1111-1286-5032
Trial acronym
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Haemodynamic disturbances 328599 0
emergence from general anaesthesia after Electroconvulsive therapy (ECT) 328600 0
Return of spontaneous ventilation 329077 0
Return of spontaneous ventilation 329078 0
Condition category
Condition code
Anaesthesiology 325612 325612 0 0
Other anaesthesiology
Anaesthesiology 326056 326056 0 0
Other anaesthesiology
Anaesthesiology 326057 326057 0 0
Other anaesthesiology
Anaesthesiology 326058 326058 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients undergoing ECT at Combined Military Hospital (CMH) Siialkot were enrolled in this prospective study, by convenient sampling method and were divided into three groups. Group D: injection dexmedetomidine 0.5 µg/kg diluted in10 ml NaCl intravenously infused over 10 min starting 10 minutes before induction of anaesthesia and Group M: injection Metoprolol 1mg diluted in 10 ml NaCl infused over 2 minutes during preoxygenation.
Intervention code [1] 325142 0
Treatment: Drugs
Intervention code [2] 325467 0
Treatment: Drugs
Comparator / control treatment
C Group included subjects not pretreated with any medicine..
Control group
Active

Outcomes
Primary outcome [1] 333450 0
Heart Rate, noted at baseline value using a cardiac monitor, then documented after administration of drugs at various time intervals.
Timepoint [1] 333450 0
base line to 10 minutes post ECT commencement
Primary outcome [2] 333451 0
. Time to emergence from anaesthesia.
.Patient anaesthesia record will be utilised to assess emergence from anaesthesia
Timepoint [2] 333451 0
in the first hour after ECT procedure
Primary outcome [3] 333915 0
Blood Pressure (Systolic & Diastolic) using cardiac monitor
Timepoint [3] 333915 0
From baseline to 10 minutes post ECT commencement
Secondary outcome [1] 417147 0
Time to recovery of spontaneous respiratory effort from patient anaesthesia record
Timepoint [1] 417147 0
in the first hour after ECT procedure

Eligibility
Key inclusion criteria
Adults undergoing Electroconvulsive therapy for any psychiatric issue
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children, people in the geriatric range, women who were pregnant, obese people, and people who had known systemic illnesses or allergies were not included.

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)
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 (i.e. computerised sequence generation)
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The data was coded before being entered into an Excel spreadsheet. Software from SPSS, version 22, was used for the analysis. Calculated descriptive statistics were used. Using one-way ANOVA, the variables in all three groups were compared.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/01/2022
Date of last participant enrolment
Anticipated
Actual
25/04/2022
Date of last data collection
Anticipated
Actual
30/04/2022
Sample size
Target
75
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 25191 0
Pakistan
State/province [1] 25191 0
Punjab

Funding & Sponsors
Funding source category [1] 312906 0
Hospital
Name [1] 312906 0
CMH Sialkot
Country [1] 312906 0
Pakistan
Primary sponsor type
Individual
Name
Khalid Mahmood
Address
CMH Sialkot, Cantt, Punjab, Pakistan
Street: Aziz Bhatti Road
Postcode: 51300
Country
Pakistan
Secondary sponsor category [1] 314585 0
None
Name [1] 314585 0
Address [1] 314585 0
Country [1] 314585 0
Pakistan
Other collaborator category [1] 282514 0
Individual
Name [1] 282514 0
Dr Mohsin Saleem
Address [1] 282514 0
CMH Sialkot, Punjab, Pakistan
Street: Aziz Bhatti Road
Postcode: 51300
Country [1] 282514 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312180 0
Ethical Review C ommittee CMH Sialkot
Ethics committee address [1] 312180 0
CMH Sialkot, Punjab, Pakistan
Street: Aziz Bhatti Road
Postcode: 51300
Ethics committee country [1] 312180 0
Pakistan
Date submitted for ethics approval [1] 312180 0
15/12/2021
Approval date [1] 312180 0
24/12/2021
Ethics approval number [1] 312180 0
ERC/12/2021
Ethics committee name [2] 312527 0
Ethical Review Committee
Ethics committee address [2] 312527 0
Combined Military Hospital Aziz Bhatti Shaheed Road Sialkot Cantt
Ethics committee country [2] 312527 0
Pakistan
Date submitted for ethics approval [2] 312527 0
15/12/2021
Approval date [2] 312527 0
24/12/2021
Ethics approval number [2] 312527 0
ERC/12/2021

Summary
Brief summary
This study was aimed at interventions that help reduce haemodynamic disturbences during Electroconvulsiive therapy under general Anaesthesia..Study hypothesis was that dexmedetomidine is effective for controllong haemodynamic disturbances following ECT procedure without significantly prolonging the emergence from anaesthesia.. Study was divided into three groups: C,D and M. . Group C included subjects not pretreated with any medicine. Group D: injection dexmedetomidine 0.5 µg/kg diluted in10 ml NaCl intravenously infused over 10 min starting 10 min before induction of anaesthesia. and Group M: injection Metoprolol 1mg diluted in 10 ml NaCl infused in 2 min duration during preoxygenation..
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123758 0
A/Prof Khalid Mahmood
Address 123758 0
CMH Sialkot, Punjab, Pakistan
Aziz Bhatti road
Postcode:51300
Country 123758 0
Pakistan
Phone 123758 0
+923028736163
Fax 123758 0
Email 123758 0
khalid1224@gmail.com
Contact person for public queries
Name 123759 0
A/Prof Khalid Mahmood
Address 123759 0
CMH Sialkot, Punjab, Pakistan
Aziz Bhatti road
Postcode:51300
Country 123759 0
Pakistan
Phone 123759 0
+923028736163
Fax 123759 0
Email 123759 0
khalid1224@gmail.com
Contact person for scientific queries
Name 123760 0
A/Prof Khalid Mahmood
Address 123760 0
CMH Sialkot, Punjab, Pakistan
Aziz Bhatti road
Postcode:51300
Country 123760 0
Pakistan
Phone 123760 0
+923028736163
Fax 123760 0
Email 123760 0
khalid1224@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.