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IRCT20141209020258N178 IRCT 2022-12-31 Arak University of Medical Sciences Comparision the effect of adjuvant Reminfentanil, Dexmedetomidine or metoral with thiopental on hemodynamic status in patients with major depressive disorder candidates for electroconvulsive therapy Comparision the effect of adjuvant Reminfentanil, Dexmedetomidine or metoral with thiopental on hemodynamic status in patients with major depressive disorder candidates for electroconvulsive therapy 2023-01-20 anticipated 90 Complete https://irct.ir/trial/67685 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be allocated into 3 groups using a permuted balanced block randomization method with the size of blocks 3 and 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method, Blinding description: Blinding is carried out in such a way that after obtaining the informed consent of the patients to participate in the study, using the randomized block method, the patients are completely randomly assigned to three equal groups of remifentanil and thiopental (group A) and dexmedomidine by the anesthesiologist. and thiopental (group B) and Metoral and thiopental (group C) are divided. Then, the drugs are prepared in advance by the anesthesiologist in charge of the plan and given to the fellow anesthesia resident who does not know the type of drugs.In all three drug groups that are used for the intervention (remifentanil-thiopental, dexmedomidine-thiopental, and metoral-thiopental), the syringes are of the same shape, and the volume of the injected drug is adjusted to CC5 in order to comply with the blinding.Also, the intern in charge of the project did not know the type of study groups from the beginning, and only after ECT induction for the patients, he is responsible for filling the questionnaires of the project, and therefore, he is not aware of the type of study groups. 2-3 major depressive disorder candidates for electroconvulsive therapy. Intervention 1: Intervention group1: Before induction of anesthesia, 100 micrograms of remifentanil is injected intravenously. Intervention 2: Intervention group 2: Before the induction of anesthesia, intravenous injection of 0.5 mg/kg dex methomidine is performed. Intervention 3: Intervention group 3: After induction of anesthesia as mentioned above, immediately before stimulation with ECT, an amount of 2.5 mg Metoral is injected . Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Dr Anita Alaghemand
Amirkabir hospital, Parastar square
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 Alaghemand@arakmu.ac.ir Arak University of Medical Sciences scientific Dr Alireza Kamali
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 68 3222 2003 alikamaliir@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) All patients with major depressive disorder are candidates for ETC Consent to participate in the study 18 to 60 years Body mass index 20 to 30 Patients with major depressive disorder who do not have other psychiatric illnesses at the same time. No history of underlying heart, lung, kidney and liver diseases No history of recent CVA or MI Insensitivity to Remifentanil or Dex Medtomidine or Metoral or Thiopental All patients who are indicated to receive ECT according to psychiatric treatment criteria. Absence of pregnancy and breastfeeding 18 years 60 years Both All patients who experience cardiorespiratory arrest during ECT. All patients who need intubation after ECT due to prolonged apnea and respiratory failure All patients who do not experience sufficient and desired seizures during ECT. All patients who want to withdraw from the study or do not want to continue electroshock therapy. F06.32 Mood disorder due to known physiological condition with major depressive-like episode Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group1: Before induction of anesthesia, 100 micrograms of remifentanil is injected intravenously Intervention group 2: Before the induction of anesthesia, intravenous injection of 0.5 mg/kg dex methomidine is performed. Intervention group 3: After induction of anesthesia as mentioned above, immediately before stimulation with ECT, an amount of 2.5 mg Metoral is injected . Average blood pressure. Timepoint: Recovery. Method of measurement: Barometer. Average heart rate. Timepoint: Recovery. Method of measurement: Pulse oximeter. Average percentage of oxygen saturation,. Timepoint: Recovery. Method of measurement: Pulse oximeter. Patient satisfaction. Timepoint: Recovery. Method of measurement: Question. Agitation. Timepoint: Recovery. Method of measurement: Physical examination. Seizure duration. Timepoint: Recovery. Method of measurement: Observation. Recovery period. Timepoint: Recovery. Method of measurement: Observation. Arak University of Medical Sciences Approved 2022-10-09 Ethics Committee Of Arak University Of Medical Sciences Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)