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IRCT20210214050355N1 IRCT 2021-05-25 Sanandaj University of Medical Sciences Evaluating the premedication effects of Fentanyl and Ketamine on perioperative hemodynamic stability and postoperative pain in patients undergoing general anesthesia Comparing the premedication effects of Fentanyl and Ketamine on perioperative hemodynamic stability and postoperative pain in patients undergoing general anesthesia using laryngeal mask for cataract surgery 2021-04-04 anticipated 98 Complete https://irct.ir/trial/54412 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sample will be assigned to 2 groups at random so that patients with the condition are assigned to the researcher in the form of a double block (AB) by the researcher. Then a pack containing 49 cards with one of the letters A and B (44 each) is considered to randomly select a card from the package and enter one of the groups according to the Latin letter. Sampling is done in parallel in 2 groups until the number of samples is completed, Blinding description: Patients are not aware of the grouping, also the drugs are coded and prepared by the nurse anesthetist and provided to the researcher (who observe and record the research process). 3 Cataract. Intervention 1: Intervention group 1: In this group, patients have prescribed 0.3 mg/kg ketamine as a premedication. After 3 minutes, induction of anesthesia with propofol at a dose of 1.5 mg/kg intravenously will be done in one dose. The injection is a single dose and the drug is a product of STEROP company in Belgium. Intervention 2: Second intervention group: In this group, 1.5 fentanyl µgr/kg is prescribed as a premedication for patients. After 3 minutes, induction of anesthesia with propofol at 1.5 mg/kg intravenously will be performed. The injection is a single dose and the drug is a product of STEROP company in Belgium. Yes - There is a plan to make this available What will be shared: Data on the primary outcomes will be shared. When: Six months after the publication of the results data access is possible. To whom: Academic Researchers Conditions: Meta-analysis is allowed. Where to obtain: Dr. Mehran Rami via email: Mehran.Rami@gmail.com How to obtain: Three months after the request, the data will be sent. Comments:
public Mehran Rami
Pasdaran St., Kowsar Hospital
Sanandaj Iran (Islamic Republic of) 66168-12131 +98 87 3361 1233 Mehran.Rami@gmail.com Sanandaj University of Medical Sciences scientific Farzad Sarshivi
Pasdaran St., Kowsar Hospital
Sanandaj Iran (Islamic Republic of) 66168-12131 +98 87 3361 1233 farzadsarshivi@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Patients with cataracts Age 40 to 70 years Being at level 1 and 2 of the ASA system Consent to participate in research 40 years 70 years Both Uncontrolled Cardiovascular disease Opioids abuse during the weak before operation Patients who are taking corticosteroids Ear disorders and Vertigo Uncontrolled Diabetes Mellitus Uncontrolled Hypertension Acute or chronic Pulmonary diseases Obesity (BMI>30) Probable Schizophrenia; Schizophrenia and in treatment Schizophrenia Brain mass; Hydrocephalus; Raised ICP Porphyria Thyroid malfunction Patients whose operation lasts more than an hour H25 Age-related cataract Treatment - Drugs Treatment - Drugs Intervention group 1: In this group, patients have prescribed 0.3 mg/kg ketamine as a premedication. After 3 minutes, induction of anesthesia with propofol at a dose of 1.5 mg/kg intravenously will be done in one dose. The injection is a single dose and the drug is a product of STEROP company in Belgium. Second intervention group: In this group, 1.5 fentanyl µgr/kg is prescribed as a premedication for patients. After 3 minutes, induction of anesthesia with propofol at 1.5 mg/kg intravenously will be performed. The injection is a single dose and the drug is a product of STEROP company in Belgium. Pain. Timepoint: 30 and 60 minutes after the end of anesthesia. Method of measurement: Visual analogue scale. Mean Arterial Pressure. Timepoint: Induction time of venous anesthesia, After induction and before placement of laryngeal mask, Immediately after laryngeal mask placement, Ten minutes after induction of anesthesia,20 minutes after induction of anesthesia, Recovery Delivery Time, Recovery Discharge Time. Method of measurement: Barometer of medical monitoring device. Harte Rate. Timepoint: Induction time of venous anesthesia, After induction and before placement of laryngeal mask, Immediately after laryngeal mask placement, Ten minutes after induction of anesthesia,20 minutes after induction of anesthesia, Recovery Delivery Time, Recovery Discharge Time. Method of measurement: Medical monitoring device. Sanandaj University of Medical Sciences Approved 2021-01-05 Ethics committee of Kurdistan University of Medical Sciences Pasdaran St. Kurdistan University of Medical Sciences Sanandaj Kurdistan Iran (Islamic Republic of)