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IRCT20210728052003N1 IRCT 2021-09-08 Sanandaj University of Medical Sciences A comparison between ketamine and precedex in treatment of shivering A comparison between intravenous ketamine and precedex (dexmedetomidine) in treatment of postoperative shivering after nose surgeries 2020-03-20 anticipated 88 Complete https://irct.ir/trial/57767 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: ASA classification:1: A person with normal health without any systemic problems. 2: A person with mild systemic disease who has not had functional limitations. 3: A person with severe systemic disease who has functional limitations for the person. 4: A person who has a severe systemic disease and whose life is in danger. 5: A person who is dying and is not expected to survive surgery. 6: A person who has died of brain damage and is sent to the operating room to donate an organ; Both groups of patients are anesthetized in a similar way:Premedication:Fentanyl 1.5 µg / kg / IV, Midazolam 1mg / IV, Lidocaine 1mg / kg / IV, Dexamethasone 8 mg / IV. All patients receive the fluid they need to compensate for the NPO based on the anesthesia group policies. Induction of anesthesia: Propofol 1.5mg / kg / IV then Atracurium 0.5mg / kg / IV. Maintenance: Isoflurane 1.5% + N2O (3L) + O2 (3L).Reverse neuromuscular block at the end of surgery: Atropine 1.5 mg and Neostigmine 2.5 mg. All patients are tubed with a spiral tube and receive the fluid they need during the operation according to the policies of the anesthesia group. The operating room temperature in all patients is 27 degrees Celsius. Cover all patients during surgery and in Recovery is the same and blankets are used to warm them in recovery. For both groups of patients, gender, age, weight, height, duration of anesthesia and duration of surgery are recorded. Gender based on men and women; Age by year; Weight by scales; Height by meter; Duration of anesthesia in minutes; Duration of surgery in minutes, Randomization description: Patients are divided into two groups receiving ketamine and Precedex using the formation of 4 random blocks and random selection from these blocks, Blinding description: To blind the study, the drugs are diluted in a volume of 2 ml and injected with syringes encrypted by a doctor who does not know the details of the treatment of patients. Patients are also not informed about the type of drug received. 4 postoperative shivering. Intervention 1: Intervention group: Ketamine group: They receives 0.3 mg / kg / IV treatment of ketamine. Intervention 2: Intervention group: Percedex receiving group: They receive 1 µg / kg / IV treatment of Percedex. Yes - There is a plan to make this available What will be shared: All data including proposal, raw data and project reports When: Data is available from the legal system six months after publication for two years. To whom: All persons will access to the data upon request to the Research and Technology Dept. of Kurdistan Medical Science. Conditions: For legal issues and the need to use data in future studies Where to obtain: Sepideh Salehi Address: Sanandaj University of Medical Sciences, Pasdaran Blvd., Sanandaj, Kurdistan Province Postal code:6617713446 00989142567880 sepideh.salehi.9595@gmail.com Behzad Ahsan Address: Kowsar Hospital, Mahvi Blvd., Pasdaran Blvd., Sanandaj, Kurdistan Province Postal code:6617983476 00989181719003 behzad.ahsan@muk.ac.ir How to obtain: After submitting a request to the Research and Technology Dept. of Kurdistan Medical Science , a call for submission is given. Comments:
public Behzad Ahsan
Kowsar Hospital, Mahvi Blvd., Pasdaran Blvd., Sanandaj, Kurdistan Province
Sanandaj Iran (Islamic Republic of) 6617983476 +98 87 3361 1232 behzad.ahsan@muk.ac.ir Sanandaj University of Medical Sciences scientific Behzad Ahsan
Kowsar Hospital, Mahvi Blvd., Pasdaran Blvd., Sanandaj, Kurdistan Province
Sanandaj Iran (Islamic Republic of) 6617983476 +98 87 3361 1232 behzad.ahsan@muk.ac.ir Sanandaj University of Medical Sciences Iran (Islamic Republic of) Patients undergoing elective nasal surgery with a duration of 1-2 hours (including rhinoplasty, septoplasty, functional endoscopic sinus surgery, polyps, and other intranasal masses) Patients receiving general anesthesia Patients with shivering after surgery Patients with ASA class one and two no limit no limit Both Patients with ASA class three and more Patients with a history of tremor and Parkinson's disease Patients with a history of thyroid, heart, kidney, and liver diseases, anemia (hemoglobin less than 9) Patients with a history of allergies Patients receiving blood during surgery Patients with a history of neurology and psychology diseases Patients with a history of myopathy Drug users M61.50 Other ossification of muscle, unspecified site Treatment - Drugs Treatment - Drugs Intervention group: Ketamine group: They receives 0.3 mg / kg / IV treatment of ketamine. Intervention group: Percedex receiving group: They receive 1 µg / kg / IV treatment of Percedex. The primary or main outcome of this study is faster treatment of shivering in patients with shivering after anesthesia. (Reduce patients' chills). Timepoint: The degree of shivering in patients is determined and recorded before receiving the drug and from zero to 10 minutes every minute after receiving the drug. Method of measurement: Postoperative shivering grading: Based on 5-digit grading (0 to 4) Grade 0: No shivering. Grade 1: Mild cold and chills on face or neck or one or more of the symptoms: Mild peripheral vasoconstriction, peripheral cyanosis, body hair spiking for no other reason. Grade 2: Moderate chills (involvement of one muscle group: oral muscle spasm) Grade 3: Severe chills (involvement of more than one muscle group without generalized involvement: spasm of all facial muscles) Grade 4: Generalized body chills. Body temperatures. Timepoint: Patients' body temperature is recorded 5 times before induction of anesthesia, at the time of entering the recovery, before receiving the drug, 5 minutes after receiving the drug and 10 minutes after receiving the drug. Method of measurement: It is measured from the axillary area by a thermometer. Hemodynamic changes. Timepoint: For both groups of patients, hemodynamic variables including HR, RR , SBP and DBP, SaO2 4 times before medication,1 minute after receiving the drug and 5 and 10 minutes after receiving the drug is recorded. Method of measurement: HR (via distal pulse of the upper limb), RR (number of patient breaths per minute), SBP and DBP (via barometer), SaO2 (via pulse oximetry). Side effects from medications. Timepoint: Patients are monitored and recorded for drug side effects, including nausea and vomiting, tachycardia, hypertension, nystagmus, delirium, and other side effects up to 30 minutes after receiving the drug. Method of measurement: Patients are evaluated after receiving the drug. Sanandaj University of Medical Sciences Approved 2020-01-07 Ethics Committee of Sanandaj University of Medical Sciences Sanandaj University of Medical Sciences, Pasdaran Blvd., Sanandaj, Kurdistan Province Sanandaj Kurdistan Iran (Islamic Republic of)