Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000274673
Ethics application status
Approved
Date submitted
4/03/2014
Date registered
14/03/2014
Date last updated
14/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of atropine and aminophylline premedication on respiratory problems after electroconvulsive therapy.
Scientific title
The effects of atropine and aminophylline premedication on respiratory problems after electroconvulsive therapy: a prospective, randomized, crossover trial
Secondary ID [1] 284203 0
nil
Universal Trial Number (UTN)
U1111-1154-0978
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
respiratory problems after electroconvulsive therapy. 291308 0
respiratory desaturation after electroconvulsive therapy 291309 0
Condition category
Condition code
Anaesthesiology 291661 291661 0 0
Other anaesthesiology
Respiratory 291662 291662 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1:before anesthesia induction 0.01mg/kg atropine intravenously will be given to patients at atropine group. once only before anesthesia induction.
Arm 2: before anesthesia induction 120 mg aminophylline intravenously will be given to patients at aminophylline group.once only before anesthesia induction.

All patients have more than 3 ECT sessions. Patients entered the study either non-premedicated as part of the control group, premedicated with atropine in the atropine group, or premedicated with aminophylline in the aminophylline group at the first three ECT sessions.Other ECT sessions (ECT sessions that after first three) were not included in the study. The group order for the patients’ ECT procedures had been determined randomly previously, using the closed envelope method. Thus, each patient was included in every group of first 3 ECT procedures in different orders randomly.

ECT sessions once every 2 or 3 days.Duration of each ECT sessions is 15-30 minutes.Duration of wash out period 2 days.

Patients were monitored for heart rate (HR) by three channel electrocardiography, noninvasive blood pressure, peripheral oxygen saturation (SpO2) and three channel electroencephalogram (EEG). Ten minutes before the anesthesia induction; 5 cc of isotonic saline, 0.01 mg/kg of atropine (5 cc), and aminophylline of 120 mg (5 cc) were infused intravenously to the control, atropine, and aminophylline groups, respectively. This was followed by anesthesia induction. During the anesthesia induction, propofol was administered in 30 seconds by titration (being no less than 1 mg/kg) until the eyelash reflex was lost. When patients became unconscious, the muscle relaxant, succinylcholine (0.5 mg/kg), was administered. Patients were ventilated with bag and mask supported with 100% oxygen during the procedure and was continued until complete awakening of the patients.
After adequate anesthesia and muscle relaxation, electroconvulsive therapy was performed using The Thymatron System IV device (Somatics, Inc, Lake Bluff, Ill) with bilateral fronto-temporal manner electrode placement. After Electroconvulsive therapy, we investigate the effects of atropine and aminophylline on respiratory problems incidance.
Intervention code [1] 288900 0
Treatment: Drugs
Intervention code [2] 288915 0
Prevention
Comparator / control treatment
placebo intravenously will be given control group (as 5cc saline)
Control group
Placebo

Outcomes
Primary outcome [1] 291590 0
Effects of atropine and aminophylline on respiratory problems that occur after electroconvulsive therapy.
The respiratory sounds were auscultated by the anesthesia physician before and after the procedure. Findings were recorded as normal respiratory sounds, fine crackles, coarse crackles or wheezing
Timepoint [1] 291590 0
immediately, 1minute and 2 minute after electroconvulsive therapy
Secondary outcome [1] 307132 0
post electroconvulsive therapy seizure's duration effect on respiratory problem incidence.
Seizure time was defined as the total time between the implementation of electricity until the last seizure seen at the end of the clonic phase (isolated forearm technique was used).
The respiratory sounds were auscultated by the anesthesia physician before and after the procedure. Findings were recorded as normal respiratory sounds, fine crackles, coarse crackles or wheezing.
Timepoint [1] 307132 0
immediately, 1minute and 2 minute after electroconvulsive therapy.

Eligibility
Key inclusion criteria
Patients aged 19- to 65 years old with an American Society of Anesthesiologists score (ASA) of I-II who had received ECT for the first time.
Minimum age
19 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- History of ECT during the preceding 6-month period, use of nonbenzodiazepine anticonvulsants (sodium valproate, carbamazepine, lamotrigine, or topiramate), lidocaine, theophylline, or lithium during the last week. 2- Neurologic illness or severe medical illness. 3- Pregnancy 4- Morbid obesity (BMI>40). 5- Hypertension (systolic blood pressure over 160 mmHg) and /or tachycardic (>90 beats/min) patients. 6- History of stroke, brain surgery. 7- Neuromuscular disease 8-Diagnosis of pulmonary disease (COPD, asthma, bronchiectasis, etc.). 9- Patients with abnormal respiratory auscultation signs before ECT procedure.

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)
The present study is a randomized, double-blind, crossover trial. All patients had 5 ECT sessions. During the first three of which the patients entered the study either non-premedicated as part of the control group, premedicated with atropine in the atropine group, or premedicated with aminophylline in the aminophylline group. The group order for the patients’ ECT procedures had been determined randomly previously, using the closed envelope method. Thus, each patient was included in every group of first 3 ECT procedures in different orders randomly. Two different investigators completed the division of patients into groups, premedication administration, and data collection
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
1/06/2011
Date of last participant enrolment
Anticipated
Actual
31/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment outside Australia
Country [1] 5864 0
Turkey
State/province [1] 5864 0
istanbul

Funding & Sponsors
Funding source category [1] 288827 0
Self funded/Unfunded
Name [1] 288827 0
Country [1] 288827 0
Primary sponsor type
Individual
Name
achmet ali
Address
istanbul medical faculty,Department of Anesthesiolo ,turgut ozal cad. no: 12, 34104 istanbul
Country
Turkey
Secondary sponsor category [1] 287521 0
None
Name [1] 287521 0
Address [1] 287521 0
Country [1] 287521 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290667 0
Ethics Committee of Istanbul University, Istanbul Medical Faculty
Ethics committee address [1] 290667 0
Ethics committee country [1] 290667 0
Turkey
Date submitted for ethics approval [1] 290667 0
03/01/2011
Approval date [1] 290667 0
21/01/2011
Ethics approval number [1] 290667 0
2010/1112-381

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

Contacts
Principal investigator
Name 46706 0
Prof ibrahim ozkan akinci
Address 46706 0
istanbul medical faculty, Department of Anesthesiology,turgut ozal cad. no:12 34104 istanbul,turkey
Country 46706 0
Turkey
Phone 46706 0
+905325942474
Fax 46706 0
Email 46706 0
[email protected]
Contact person for public queries
Name 46707 0
achmet ali
Address 46707 0
istanbul medical faculty, Department of Anesthesiology,turgut ozal cad. no:12 34104 istanbul,turkey
Country 46707 0
Turkey
Phone 46707 0
+905424878264
Fax 46707 0
Email 46707 0
[email protected]
Contact person for scientific queries
Name 46708 0
achmet ali
Address 46708 0
istanbul medical faculty, Department of Anesthesiology,turgut ozal cad. no:12 34104 istanbul,turkey
Country 46708 0
Turkey
Phone 46708 0
+905424878264
Fax 46708 0
Email 46708 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effects of atropine and aminophylline premedication on respiratory problems after electroconvulsive therapy: A prospective, randomized, crossover trial.2015https://dx.doi.org/10.5455/bcp.20150505104413
N.B. These documents automatically identified may not have been verified by the study sponsor.