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IRCT20111010007752N12 IRCT 2021-08-22 Babol University of Medical Sciences Comparison of pregabalin and fentanyl after endotracheal intubation Comparison of hemodynamic responses of Pergabaline and fentanyl after endotracheal intubation in lumbar spine surgery : A double-blind clinical trial 2021-08-23 anticipated 64 Complete https://irct.ir/trial/57733 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to two groups of 32 using 4 blocks and a ratio of 1: 1. The free website www.randomization.com will be used to generate the allocation sequence. The resulting sequence will be written on separate sheets and placed in sealed envelopes and will be provided to the lead researcher for study, Blinding description: Pregabalin is in the form of capsules. In order to blind the capsules containing placebo, they are selected in a completely identical shape and identical to pregabalin capsules, so that they are completely similar in terms of smell, color and form. Capsules containing pregabalin and placebo are placed in one-size, one-size-fits-all cans and then a 3-digit code is written on each can. After the patient enters the study, one of these cans is assigned to the patient and the code is written on the can on the patient's file (study checklist). Unlock the codes will be done after the study. N/A Acute pain. Intervention 1: Intervention group: 8 hours before surgery, 75 mg capsules containing pregabalin (Sanamod company) are administered orally. In addition, fentanyl (Caspian company) 1 microgram/kg in 50 ml of normal saline will be given 10 minutes before endotracheal intubation. Intervention 2: Control group: Capsules containing placebo are given orally 8 hours before surgery. In addition, fentanyl (Caspian company) 1 microgram/kg in 50 ml of normal saline will be given 10 minutes before endotracheal intubation. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is still no plan for its publish.
public Parviz Amri
Ayatollah Rouhani Hospital, Daneshgah Square, Ganjafrooz Avenue
Babol Iran (Islamic Republic of) 47176-41367 +98 11 3233 8301 pamrimaleh@gmail.com Babol University of Medical Sciences scientific Parviz amri
Ayatollah Rouhani Hospital, Daneshgah Square, Ganjafrooz Avenue
Babol Iran (Islamic Republic of) 47176-41367 +98 11 3233 8301 pamrimaleh@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Age 20-65 years old The American Society of Anesthesiologists (ASA) class I&II ( Grade 1: No cardiovascular, respiratory, glandular and Grade 2: Controlled diabetes) 20 years 65 years Both Drug addiction Hypertension and antihypertensive drugs consumers Difficult intubation Bradycardia G89.18 Other acute postprocedural pain Treatment - Drugs Treatment - Drugs Intervention group: 8 hours before surgery, 75 mg capsules containing pregabalin (Sanamod company) are administered orally. In addition, fentanyl (Caspian company) 1 microgram/kg in 50 ml of normal saline will be given 10 minutes before endotracheal intubation Control group: Capsules containing placebo are given orally 8 hours before surgery. In addition, fentanyl (Caspian company) 1 microgram/kg in 50 ml of normal saline will be given 10 minutes before endotracheal intubation. Blood Pressure. Timepoint: Before prescribing the drug; before laryngoscopy; after intubation, 1, 3, 5,10 minutes after intubation؛ after surgical incision. Method of measurement: Monitoring of blood pressure, mm Hg. ‌Heart Rate. Timepoint: Before prescribing the drug; before laryngoscopy; after intubation, 1, 3, 5,10 minutes after intubation؛ after surgical incision. Method of measurement: Number per minute. O2 saturation. Timepoint: Before prescribing the drug; before laryngoscopy; after intubation, 1, 3, 5,10 minutes after intubation؛ after surgical incision. Method of measurement: Pulse oximeter. Babol University of Medical Sciences Approved 2021-05-31 Ethics Committee of Babol University of Medical Siences Daneshgah Square, Ganjafrooz Avenue Babol Mazandaran Iran (Islamic Republic of)