Comparing the Effect of Propofol-Dexmedetomidine versus Propofol in Anesthesia Induction in Patients with Major Depression or Bipolar-Disorder under Electroconvulsive therapy
The purpose of this research is to investigate the propofol-dexmedetomidine in comparison with propofol in induction of anesthesia in patients with major depression or bipolar disorder for electroconvulsive therapy.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 per 82 patients. Random computer- generated numbers will be used for randomization.
Settings and conduct
Effects of propofol-dexmedetomidine in induction of anesthesia in patients with major depression or bipolar disorder who referred to Qods Hospital in Sanandaj for electroconvulsive therapy. After dividing the patients by computer random number generation, intervention group 1 patients received propofol 1 mg/kg along with 0.5 μg/kg dexmedetomidine and intervention group 2 patients received propofol 1 mg/kg. For blinding, the patient and evaluator is not aware of the grouping.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1. Age 18 to 50 years,
2. Patient in ASA class 1 or 2 physical status,
3. A patient diagnosed with major depression or bipolar disorder referred by a psychiatrist.
Exclusion Criteria:
1. History of cardiovascular, kidney, liver and lung disease
2. History of other mental diseases, except major depression or bipolar disorder
3. History of head trauma
4. History of cardiovascular surgery
5. History of allergy to propofol or foods such as eggs or soybeans
6. Patients under treatment with bupropion and anticonvulsant
7. The doctor's lack of consent for the patient's participation in the study
Intervention groups
Patients in the group 2, receiving propofol at a dose of 1 mg/kg plus, 0.5 μg/kg of dexmedetomidine.
Patients in the group 2 receiving propofol at a dose of 1 mg/kg.
Main outcome variables
-Seizure duration
- Recovery time
- Mean arterial pressure
- Sedation/Agitation score in recovery
Pain score in recovery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231009059668N1
Registration date:2023-10-22, 1402/07/30
Registration timing:prospective
Last update:2023-10-22, 1402/07/30
Update count:0
Registration date
2023-10-22, 1402/07/30
Registrant information
Name
Fatemeh Karimkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3362 7228
Email address
dr.fatemehkarimkhani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Propofol-Dexmedetomidine versus Propofol in Anesthesia Induction in Patients with Major Depression or Bipolar-Disorder under Electroconvulsive therapy
Public title
Effect of Propofol-Dexmedetomidine in Anesthesia Induction in Patients with Major Depression or Bipolar-Disorder under Electroconvulsive therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 50 years
Patient in class 1 or 2 ASA physical status
Patient diagnosed with major depression or bipolar disorder referred by a psychiatrist
Exclusion criteria:
History of cardiovascular, kidney, liver and lung disease
History of other mental diseases, except major depression or bipolar disorder
History of head trauma
History of cardiovascular surgery
History of allergy to propofol or foods such as eggs or soybeans
Patient under treatment with bupropion and anticonvulsant
The attending physician's lack of consent for the patient's participation in the study
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done randomly using computer generated random numbers. Thus, each "odd number" produced belongs to group 1 (intervention group) and each randomly generated "even number" belongs to group 2 (patient placement in the control group)
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind this study, patients do not know which study groups they are in. Also, the prepared medication (dexmedetomidine- propofol OR propofol), in the same volume and appearance, is prepared and coded by an anesthesia nurse who is not present in the study. The anesthesiologist who also performs the procedure is not aware of the prescription medication and the grouping of patients. Patients will be evaluated by an anesthesia resident who is not aware of the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Kurdistan University of Medical Sciences
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617913446
Approval date
2022-01-25, 1400/11/05
Ethics committee reference number
IR.MUK.REC.1400.273
Health conditions studied
1
Description of health condition studied
Bipolar disorders
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
2
Description of health condition studied
Major depression
ICD-10 code
F33
ICD-10 code description
Major depressive disorder, recurrent
Primary outcomes
1
Description
Seizure duration
Timepoint
The end of the discharge time of the electric shock until the completion of all visible movements in all parts of the body
Method of measurement
Timer (seconds)
2
Description
Recovery time
Timepoint
From the end of the injection of succinylcholine to the return of breathing and opening the eyes and following the instructions completely correctly by the patients