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Trial registered on ANZCTR


Registration number
ACTRN12613000054718
Ethics application status
Approved
Date submitted
9/01/2013
Date registered
16/01/2013
Date last updated
16/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Rocuronium and Sugammadex on Myalgia and Headache After Electro-Convulsive Therapy
Scientific title
Does Rocuronium-sugammadex reduce Myalgia and headache after ECT in patients with major depression?
Secondary ID [1] 281743 0
no
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myalgia after electroconvulsive therapy (ECT)
288049 0
Headache after electroconvulsive therapy (ECT) 288050 0
Major depression 288103 0
Condition category
Condition code
Anaesthesiology 288425 288425 0 0
Pain management
Mental Health 288426 288426 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twenty one patients for group R undergoing ECT were included in the study. Anesthesia induction was provided with propofol 1 mg/kg IV and rocuronium 0,3 mg/kg IV in the Group R (n=21). Electroshock was applied after obtaining full muscular relaxation. Sugammadex 4 mg/kg IV was administered to after the motor seizure. Receiving ECT three times a week to complete an average of 6 to 12 treatments. The first three ECT sessions were included in the study. The patients were evaluated as regards the time of start of spontaneous respiration following the induction, time of opening the eyes in response to verbal stimuli, and VAS scores for myalgia and headache at hours 2, 6, 12 and 24 following the ECT.
Intervention code [1] 286281 0
Treatment: Drugs
Comparator / control treatment
Twenty Four for group S patients undergoing ECT were included in the study. Anesthesia induction was provided with propofol 1 mg/kg intravenously (IV) and succinylcholine 1 mg/kg IV in the Group S (n=24), Electroshock was applied after obtaining full muscular relaxation. Receiving ECT three times a week to complete an average of 6 to 12 treatments. The first three ECT sessions were included in the study. The patients were evaluated as regards the time of start of spontaneous respiration following the induction, time of opening the eyes in response to verbal stimuli, and VAS scores for myalgia and headache at hours 2, 6, 12 and 24 following the ECT.
Control group
Active

Outcomes
Primary outcome [1] 288592 0
Compare the effects of succinylcholine and rocuronium-sugammadex on visual analogue scale (VAS) myalgia and headache after ECT
Timepoint [1] 288592 0
Visual analogue scale (VAS) myalgia and headache was measured after 2, 6, 12 and 24 hours following each ECT session.
Secondary outcome [1] 300546 0
the awakening time (spontaneous respiration and opening the eyes in response to verbal stimuli) in group R and group S.
Timepoint [1] 300546 0
Measured from the time of anaesthesia induction until awakening time.

Eligibility
Key inclusion criteria
who would receive ECT three times a week due to major depression, without a history of ECT in the past, between 18-65 years of age, and had a physical status of ASA I and II. Of the 6-12 sessions of ECT, the first three were included in the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with neuromuscular, cardio-vascular and renal disease, and those who were pregnant and patients with pre-existing chronic pain were excluded from the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2012
Actual
6/02/2012
Date of last participant enrolment
Anticipated
15/06/2012
Actual
20/07/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4783 0
Turkey
State/province [1] 4783 0
Gazizantep

Funding & Sponsors
Funding source category [1] 286532 0
University
Name [1] 286532 0
Gaziantep University
Country [1] 286532 0
Turkey
Primary sponsor type
University
Name
Gaziantep University
Address
Gaziantep University Medical Faculty,
Department of Anesthesiology and Reanimation ,
27310 Sahinbey,
Country
Turkey
Secondary sponsor category [1] 285320 0
None
Name [1] 285320 0
Address [1] 285320 0
Country [1] 285320 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36894 0
Dr Vahap Saricicek
Address 36894 0
Gaziantep University Medical Faculty,
Department of Anesthesiology and Reanimation ,
27310 Sahinbey,
Gaziantep, TURKEY
Country 36894 0
Turkey
Phone 36894 0
+90 5335491664
Fax 36894 0
Email 36894 0
vahapsaricicek@hotmail.com
Contact person for public queries
Name 36895 0
Vahap saricicek
Address 36895 0
Gaziantep University Medical Faculty,
Department of Anesthesiology and Reanimation ,
27310 Sahinbey,
Gaziantep, TURKE
Country 36895 0
Turkey
Phone 36895 0
+90 5335491664
Fax 36895 0
Email 36895 0
vahapsaricicek@hotmail.com
Contact person for scientific queries
Name 36896 0
Levent Sahin
Address 36896 0
Gaziantep University Medical Faculty,
Department of Anesthesiology and Reanimation ,
27310 Sahinbey,
Gaziantep, TURKE
Country 36896 0
Turkey
Phone 36896 0
+90 3423606060-77804
Fax 36896 0
Email 36896 0
drlsahin@gmail.com

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
No additional documents have been identified.