]>
IRCT20160307026950N36 IRCT 2021-10-14 Esfahan University of Medical Sciences Evaluation of the effect of Quetiapine and Diclofenac in reducing pain in lower limb surgeries Comparison of the effect of prophylactic administration of Quetiapine and Diclofenac sodium on pain relief after major lower limb and pelvic surgeries under spinal anesthesia 2021-10-23 anticipated 105 Complete https://irct.ir/trial/58435 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: This is a simple randomized clinical trial in which individuals enter study groups by lottery; The drugs and placebo are placed in the desired number in sealed opaque and uniform sealed envelopes. Each of the codes is also written on a piece of paper, folded and placed inside a box. After entering the operating room, each patient takes one of the papers out of the box. Which is applied to the patient. This continues until the end of the paperwork so that the number of patients in the desired volume in the groups, Blinding description: This is a two-blind study, patients are explained that during the study they are placed in one of the groups by lottery, but the type of intervention is not known in advance, so the patient is unaware of the type of intervention despite the conscious participation in the study and is therefore blind. Medications are also prescribed by a researcher who is not involved in evaluating the patient and analyzing the results. An anesthesiologist who is in charge of anesthesia management and data collection during and after surgery, as well as the researcher who evaluates and analyzes the results, will not know the type of drug prescribed and therefore are all blind. 3 Amount of post operation pain. Intervention 1: Intervention group A: In this group, patients who have not eaten for at least 8 hours before the operation receive 50 mg of oral Quitiapine 30 minutes before induction of anesthesia and then undergo standard monitoring. 0.03 mg / kg Midazolam and 2 μg / kg Fentanyl are injected intravenously as a premedication , then the patient is placed under spinal anesthesia. Intervention 2: Intervention group B: In this group, patients who have not eaten for at least 8 hours before the operation receive100 mg of oral Diclofenac 30 minutes before induction of anesthesia and then undergo standard monitoring. 0.03 mg / kg Midazolam and 2 μg / kg Fentanyl are injected intravenously as a premedication , then the patient is placed under spinal anesthesia. Intervention 3: Control group C: In this group, patients who have not eaten for at least 8 hours before the operation receive One placebo pill 30 minutes before induction of anesthesia and then undergo standard monitoring. 0.03 mg / kg Midazolam and 2 μg / kg Fentanyl are injected intravenously as a premedication , then the patient is placed under spinal anesthesia. 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 Azadeh Erfani
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 Azadeherf18@gmail.com Esfahan University of Medical Sciences scientific Behzad Nazem roaya
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Age 18 to 64 years ASA Class I and II Anesthesia Candidate for major lower limb and pelvic surgeries Candidate for spinal anesthesia Patient informed consent to participate in the study 18 years 65 years Both Taking psychotropic or sedative drugs Opioid and non-opioid drug addiction Diabetes, orthostatic hypotension, bradycardia, hypokalemia, hypothyroidism, depression, dementia, prolonged QT syndrome Pregnancy and lactation Obesity (BMI>30) Prevention Prevention Placebo Intervention group A: In this group, patients who have not eaten for at least 8 hours before the operation receive 50 mg of oral Quitiapine 30 minutes before induction of anesthesia and then undergo standard monitoring. 0.03 mg / kg Midazolam and 2 μg / kg Fentanyl are injected intravenously as a premedication , then the patient is placed under spinal anesthesia. Intervention group B: In this group, patients who have not eaten for at least 8 hours before the operation receive100 mg of oral Diclofenac 30 minutes before induction of anesthesia and then undergo standard monitoring. 0.03 mg / kg Midazolam and 2 μg / kg Fentanyl are injected intravenously as a premedication , then the patient is placed under spinal anesthesia. Control group C: In this group, patients who have not eaten for at least 8 hours before the operation receive One placebo pill 30 minutes before induction of anesthesia and then undergo standard monitoring. 0.03 mg / kg Midazolam and 2 μg / kg Fentanyl are injected intravenously as a premedication , then the patient is placed under spinal anesthesia. The severity of postoperative pain. Timepoint: Base time (before intervention), awakening, 1, 2, 4, 6 and 24 hours after surgery. Method of measurement: Visual Analogue Scale (0 to 10). Moderate arterial blood pressure. Timepoint: Base time (before intervention), awakening, 1, 2, 4, 6 and 24 hours after surgery. Method of measurement: Barometer. Heart Rate. Timepoint: Base time (before intervention), awakening, 1, 2, 4, 6 and 24 hours after surgery. Method of measurement: ECG. Arterial blood oxygen saturation. Timepoint: Base time (before intervention), awakening, 1, 2, 4, 6 and 24 hours after surgery. Method of measurement: Pulse oximeter. Complications (such as nausea, vomiting, dizziness, drowsiness, headache). Timepoint: Base time (before intervention), awakening, 1, 2, 4, 6 and 24 hours after surgery. Method of measurement: Asking. Esfahan University of Medical Sciences Approved 2021-05-22 Ethics Committee in Biomedical Research, Isfahan University of Medical Sciences Hezar Jarib St Isfahan Isfehan Iran (Islamic Republic of)