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IRCT20210108049969N1 IRCT 2021-01-10 Khoram-Abad University of Medical Sciences The effect of ketamine and oxytocin on pain control, nausea, blood pressure, heart rate, satisfaction, postoperative blood oxygen saturation in patients undergoing elective laparoscopic gallbladder surgery The effect of ketamine and oxytocin on postoperative pain control in patients undergoing elective laparoscopic gallbladder surgery 2019-12-14 anticipated 120 Complete https://irct.ir/trial/53576 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random number table Random number table Table of Random Numbers A set of masses of Numbers that are produced without a specific pattern or order and in a completely random manner and are in the form of a table. In order to use a random number table, the researcher must first preset the table to read the numbers (for example, up, down, left, or right (the researcher's second assumption is to consider numbers for different groups), for example, even numbers for intervention. A and odd numbers for Intervention B, another method of taking the number 0-40 for intervention A and the number 41-80 for Intervention B is the numbers 120-181 for group C, then the researcher touches one of the numbers and moves in one of the predetermined directions and records the numbers and Allocates different groups, Blinding description: All blind people only know that participants are divided into 4 groups, but do not know the type of treatment intervention in each group to control pain, nausea, hemodynamic changes such as blood pressure and heart rate, arterial oxygenation and patient satisfaction, and assign patients in 4 groups. It was done completely randomly through a table of random numbers, which is described as how to do it. 3 Condition 1: Status and comparison of pain after laparoscopic cholecystectomy in 3 study group. Condition 2: Status and comparison of nausea after laparoscopic cholecystectomy in 3 study group. Condition 3: Status and comparison of hemodynamic changes (blood pressure, heart rate, blood oxygenation) after laparoscopic cholecystectomy in 3 study group. Intervention 1: Intervention group: Receiving 0.5 mg of ketamine per kg of patient weight and oxytocin 0.5 units per kg of patient weight immediately after patient extubation. All of the following were similar in all three groups: Time Operation ١ - ٢ Hour, drugs used during surgery (for premedication of fentanyl 1-2 micrograms per kilogram - Midaz slide 0/05-0/15mg per kg body weight - Atracorium 0/5mg per kg Kg patient weight, propofol 1.5-2/5 mg / kg body weight, under isoflurane1/2% inhalation anesthesia as maintenance anesthetic, similar serum therapy. Intervention 2: Intervention group: Receiving 0.5 mg of pethidine per kg of patient weight is prescribed immediately after the patient's extubation. All of the following were the same in all three groups: time of operation 1-2 hour, intraoperative drugs (for premedication from Fentanyl 1-2 micrograms per kilogram - Midazolam 0/05-0/15 milligrams per kilogram body weight - Atracorium 0.5 mg per kilogram patient weight, Propofol 1.5-2.5 mg Per kilogram of body weight, under inhaled anesthesia with iso-fluorine 1/2 ٪ as maintenance anesthetic, similar serum therapy. Intervention 3: Control group: Do not receive medication, however, each group was prescribed 4 mg of ondansetron and 5 micrograms of sufentanil after extubation. No - There is not a plan to make this available Justification or reason for not sharing IPD is Privacy of the patients
public Maryam Baghizadeh Baghdashti
Enqelab Ave,Shohadaye-Ashayer Hospital
Khoram-Abad Iran (Islamic Republic of) 6816933132 +98 66 3323 6401 M.baghizadeh65@gmail.com Khoram-Abad University of Medical Sciences scientific Arash Karimi
Enqelab Ave,Shohadaye -Ashayer Hospital
Khoram-Abad Iran (Islamic Republic of) 6816933132 +98 66 3323 6401 M.baghizadeh65@gmail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients aged 30-60 years who have undergone laparoscopic cholecystectomy No pulmonary disease ASA class 1(American Society of Anesthesiologists ) is a system for assessing the fitness of patients before surgery No history of chronic pain after surgery 30 years 60 years Both History of chronic pain Specific drug dependence such as opium History of psychiatric illness Rehabilitation Rehabilitation N/A Intervention group: Receiving 0.5 mg of ketamine per kg of patient weight and oxytocin 0.5 units per kg of patient weight immediately after patient extubation. All of the following were similar in all three groups: Time Operation ١ - ٢ Hour, drugs used during surgery (for premedication of fentanyl 1-2 micrograms per kilogram - Midaz slide 0/05-0/15mg per kg body weight - Atracorium 0/5mg per kg Kg patient weight, propofol 1.5-2/5 mg / kg body weight, under isoflurane1/2% inhalation anesthesia as maintenance anesthetic, similar serum therapy Intervention group: Receiving 0.5 mg of pethidine per kg of patient weight is prescribed immediately after the patient's extubation. All of the following were the same in all three groups: time of operation 1-2 hour, intraoperative drugs (for premedication from Fentanyl 1-2 micrograms per kilogram - Midazolam 0/05-0/15 milligrams per kilogram body weight - Atracorium 0.5 mg per kilogram patient weight, Propofol 1.5-2.5 mg Per kilogram of body weight, under inhaled anesthesia with iso-fluorine 1/2 ٪ as maintenance anesthetic, similar serum therapy Control group: Do not receive medication, however, each group was prescribed 4 mg of ondansetron and 5 micrograms of sufentanil after extubation. Pain score based on visual analague scale. Timepoint: After surgery in the recovery room, 1 and 2 hours after surgery. Method of measurement: Visual analogue scale. Arash karimi-maryam baghizadeh Approved 2019-12-01 Ethics Committee of Lorestan University of Medical Sciences Moallem St., Shahid Anoushirvan Rezaei Sq., University of Medical Sciences Khoram-Abad Lorestan Iran (Islamic Republic of)