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IRCT20171012036730N2 IRCT 2018-02-25 Tehran University of Medical Sciences Effect of ketamine and haloperidol with pethidine and haloperidol for prevention of catheter-related bladder discomfort Comparison of catheter-related bladder discomfort in the two methods of Haloperidol and Ketamine with Haloperidol and Pethidine in male patients after elective lumbar spine Laminectomy 2016-09-22 anticipated 119 Complete https://irct.ir/trial/27375 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization method: Simple randomization, randomization unit: individual, randomization tool: random number table, Blinding description: In this study, the patients, measuring the outcomes of study participants (researchers) or Data Monitoring Committee (analyzers) of the patients unaware about intervention. 3 Catheter related bladder discomfort. Intervention 1: Intervention 1: 0.04 mg/kg haloperidol and 0.5 mg/kg ketamine. Intervention 2: Intervention 2: 0.04 mg/kg haloperidol and 0.5 mg/kg pethidine. Intervention 3: Intervention 3: Normal saline as placebo. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of information
public Nazafarin Kamalzadeh
Sina Hospital, Imam Khomeini street
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 nkamalzadeh@razi.tums.ac.ir Tehran University of Medical Sciences scientific Mohammad Reza Khajavi
Sina Hospital, Imam Khomeini sreet
Tehran Iran (Islamic Republic of) 11136746911 +98 21 6634 8500 khajavim@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 70 years Male gender American Society of Anesthesiologists (ASA) physical status classification I, II 18 years 70 years Male Inability of extubating the patients after surgery Any history of urological surgery Patients who have any damage or distracting pain other than the site of surgery Patients with any lesion and central nervous system disease History of chronic pain History of opioids or other substances consumption chronically Benign Prostatic Hyperplasia or any urinary system obstruction Urinary tract infection or urinary tract stone Severe heart and liver disease or evidence of long QT segment in electrocardiography History of overactive bladder (need to urinate more than 3 times during sleep or more than 8 times a day) Obesity (body mass index more than 40 kilogram per square meter) Dementia or any disorder which leads to inappropriate orientation and inability to communicate verbally End stage renal disease (urinary volume less than 500cc per 24 hours) Proved mental illness Any apparent bladder dysfunction due to lumbar spinal cord stenosis Sensitivity to phenylephrine, ketamine or pethidine History of monoamine oxidase inhibitor (MAOI) usage in the recent two weeks Y84.6 Urinary catheterization as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure Treatment - Drugs Treatment - Drugs Placebo Intervention 1: 0.04 mg/kg haloperidol and 0.5 mg/kg ketamine Intervention 2: 0.04 mg/kg haloperidol and 0.5 mg/kg pethidine Intervention 3: Normal saline as placebo Catheter Related Bladder Discomfort severity. Timepoint: 0, 1, 6, 24 hours after surgery. Method of measurement: based on asking patients based on Likert scale. Pain. Timepoint: 0, 1, 6, 24 hours after surgery. Method of measurement: Visual Analogue Scale (VAS). Sedation. Timepoint: 0, 1, 6, 24 hours after surgery. Method of measurement: Richmond Sedation Score (RSS). Sina hospital Research Center, Tehran university of medical sciences Approved 2016-06-07 Ethics Committee of Tehran University of Medical Sciences Research and Technology Department, 6th floor, Central Organization of the University, Ghods street, Keshavarz boulevard Tehran Tehran Iran (Islamic Republic of)