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IRCT20141209020258N161 IRCT 2021-06-22 Arak University of Medical Sciences Comparison of Zolpidem and melatonin in postoperative pain control in intervertebral disc herniation surgery under general anesthesia Comparison of Zolpidem and melatonin in postoperative pain control in intervertebral disc herniation surgery under general anesthesia 2021-06-15 anticipated 60 Complete https://irct.ir/trial/56546 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple individual randomization with random allocation with envelopes in 2 groups A and B . In this method, we selected a number of cards or letters as an intervention group and the same ‎number of cards for the control group, then the cards were merged. One card was taken out and its ‎allocation was registered and the card was returned to the other cards after leaving. Then the cards ‎are merged again and we remove another card. This process continues to reach a random sequence ‎according to sample size, Blinding description: Outcome assessor and data analyzer and participant are blind (double blind). Outcome assessor and data analyzer and participant don't aware from grouping. The intern is unaware of the drugs prescribed in each group and the anesthesiologist prepares the drugs and provides them to the intern. Also, the patients do not know about their group.The syringes are covered with foil. 3 Herniated lumbar intervertebral disc. Intervention 1: Intervention group 1: We will prescribe 6 milligram of sublingual melatonin (Webber Natural Co) dissolved in water (final volume 5 ml) 90 minutes before surgery. Intervention 2: Intervention group 2:We will prescribe 10 milligram of zolpidem in the form of tablets dissolved in water (manufactured by Hakim Pharmaceutical Company - Iran) 90 minutes before surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Dr Esmaeel Moshiri
Shahid Shirodi street, Valiasr square, Valiasr hospital
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences scientific Dr Hesamedin Modir
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
Arak Iran (Islamic Republic of) 3814957558 +98 86 3222 2003 modir.he@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Candidate for intervertebral disc herniation surgery 17 to 65 years Both gender Absence of coagulation disorders Absence of liver disease and renal disease and heart disease No history of drug use in the last 48 hours No addiction to drugs, psychedelics and alcohol Lack of sensitivity to the studied drugs Lack of platelet count less than 150 thousand No family history of thromboembolism Absence of severe hemodynamic instability L2 - L5 surgery and laminectomy 17 years 65 years Both Reluctance to participate in the study M51.26 Other intervertebral disc displacement, lumbar region Treatment - Drugs Treatment - Drugs Intervention group 1: We will prescribe 6 milligram of sublingual melatonin (Webber Natural Co) dissolved in water (final volume 5 ml) 90 minutes before surgery. Intervention group 2:We will prescribe 10 milligram of zolpidem in the form of tablets dissolved in water (manufactured by Hakim Pharmaceutical Company - Iran) 90 minutes before surgery. Pain. Timepoint: During recovery and at 2, 4, 6, 12 and 24 hours after surgery. Method of measurement: Visual analog scale of pain. Mean of narcotics consumption. Timepoint: 24 hours after surgery. Method of measurement: Patient file. Arak University of Medical Sciences Approved 2021-04-21 Ethics comittee of Arak University of Medical Sciences Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak Arak Markazi Iran (Islamic Republic of)