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IRCT20170413033408N2 IRCT 2019-10-30 Gorgan University of Medical Sciences The effect of ketamine on pain relief after laparoscopic cholecystectomy The effects of low dose ketamine on postoperative pain, opioid consumption and hemodynamic changes in patients undergoing laparoscopic cholecystectomy 2019-11-20 anticipated 66 Complete https://irct.ir/trial/42761 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The initial selection will be unlikely and availability of the eligible patients.But the type of intervention is based on simple random sampling, Blinding description: In both groups will be prescribed ketamine or placebo (normal saline) after anesthesia. To make the drugs unrecognizable to patients and researchers, they are both administered in an identical volume and format and are labeled A and B by the anesthesiologist assistant. Because the drugs are administered and administered by the anesthesiologist assistant, the outcome of the study will be measured and recorded by the anesthesiologist present in the recovery room who is unaware of the type of drug being administered. 3 Patients with cholecystitis. Intervention 1: Intervention group: After preparation of the surgical site and before surgical incision (for laparoscopic trochar passage and CO2 gas blowing), Ketamine is injected at a dose of 0.5mg/kg(Mfr.STEROP Belgium) as a bolus (single injection). Also, if the surgery lasts more than one hour in the target group, half the previous dose (0.25mg/kg) is used. Intervention 2: Control group: After preparation of the surgical site and before surgical incision (for laparoscopic trochar passage and CO2 gas blowing),placebo (normal saline) (in the same volume as ketamine) is injected as a bolus (single injection). Normal saline (in the same volume as ketamine) is also used in the control group if the operation lasts more than one hour. Normal saline is the brand name of normal saline solution which is containing 0.9% sodium chloride or 300 mOsm/L. Yes - There is a plan to make this available What will be shared: Information on the main outcome When: Since 2022 To whom: Researchers working in academic institutions Conditions: No manipulation, mentioning the data reference Where to obtain: Seyed Babak Mojaver Aghili, drbabaka35@gmail.com, Gorgan, 4 km, Sari, Golestan University of Medical Sciences, Gorgan, Iran. Deputy of Research and Technology, Gorgan, Golestan, Iran. How to obtain: sending an email, complete the personal and professional characteristics with documentation Comments:
public Seyed Babak Mojaver Aghili
Gorgan, 4 km, Sari, Golestan University of Medical Sciences, Gorgan, Iran. Deputy of Research and Technology, Gorgan, Golestan, Iran
Gorgan Iran (Islamic Republic of) 49341-74515 +98 17 3253 8011 drbabaka35@gmail.com Gorgan University of Medical Sciences scientific Seyed Babak Mojaver Aghili
Gorgan, 4 km, Sari, Golestan University of Medical Sciences, Gorgan, Iran. Deputy of Research and Technology, Gorgan, Golestan, Iran
Gorgan Iran (Islamic Republic of) 49341-74515 +98 17 3253 8011 drbabaka35@gmail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Patients with Class 1 and 2 physical activity according to the American Society of Anesthesiologists (ASA1, 2) who have completed the consent form Age range 18-60 years 18 years 60 years Both Abuse of drugs or opioids or psychotropic drugs A history of seizures or taking anticonvulsants Sensitivity to ketamine or anesthetic induction drugs A history of high Intra cranial pressure (ICP) Patients with BMI≥40 K80.0 Calculus of gallbladder with acute cholecystitis Treatment - Drugs Treatment - Drugs Intervention group: After preparation of the surgical site and before surgical incision (for laparoscopic trochar passage and CO2 gas blowing), Ketamine is injected at a dose of 0.5mg/kg(Mfr.STEROP Belgium) as a bolus (single injection). Also, if the surgery lasts more than one hour in the target group, half the previous dose (0.25mg/kg) is used. Control group: After preparation of the surgical site and before surgical incision (for laparoscopic trochar passage and CO2 gas blowing),placebo (normal saline) (in the same volume as ketamine) is injected as a bolus (single injection). Normal saline (in the same volume as ketamine) is also used in the control group if the operation lasts more than one hour. Normal saline is the brand name of normal saline solution which is containing 0.9% sodium chloride or 300 mOsm/L. Postoperative pain. Timepoint: During the first 24 hours after surgery. Method of measurement: By Visual Analogue Scale (Score 1-10, 1=No pain, 10= worst pain). The amount of opioids consumption. Timepoint: During the first 24 hours after surgery. Method of measurement: The total dose of the drug administrated. Changes in Systolic and diastolic blood pressure. Timepoint: After blowing gas into the peritoneal cavity and during the surgery. Method of measurement: Measurement of systolic and diastolic blood pressure by a barometer in millimeters of mercury (mmHg). Changes in mean arterial pressure. Timepoint: After blowing gas into the peritoneal cavity and during the surgery. Method of measurement: Mean arterial pressure in millimeters of mercury (mmHg), measured by systolic blood pressure and diastolic blood pressure by a barometer and calculate through Mean arterial pressure = systolic blood pressure + 2(diastolic blood pressure)/3. Gorgan University of Medical Sciences Approved 2019-09-22 Ethics Committee of Golestan University of Medical Sciences Gorgan, 4 km, Sari, Golestan University of Medical Sciences, Gorgan, Iran. Deputy of Research and Technology of Gorgan, Gorgan, Gorgan Gorgan Golestan Iran (Islamic Republic of)