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IRCT20230824059251N1 IRCT 2023-09-01 Islamic International Medical College and Wah medical college Dexmeditomidine as adjuvant to anesthesia The Impact of ADRA2A and CYP2A6 Gene Polymorphism on sedative and analgesic effect of Dexmedetomidine 2023-09-10 anticipated 300 Complete https://irct.ir/trial/72286 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients fullfiling the inclusion criteia, will be randomized into two groups by computer generated random numbers( Simple ramdomization) by assibning participants in control group with odd numbers and intervention group with even number. intervention Group will be administered 1µg/kg dexmedetomidine hydrochloride diluted in 20ml normal saline intravenously over 10 min as a bolus just before the induction in addition to the standard anaesthesia protocol, followed by maintenance dose of 0.5 μg/kg/hr in another 20 ml of saline till the end of surgery.The control group will receive 20ml intravenous infusion of normal saline 0.9 % over 10 minutes followed by continuous infusion of 12.5 ml of normal saline till the end of surgeryin addition to anesthetic agents decided. Pre-operative variable like demographic data ,hemodynamics profile,then at three point interval blood sampling for drug levels, anti-inflammatory markers and genotyping and levels of analgesia and sedation will be assessed as described in next section, Blinding description: All participants were not given information about the investgational drug. Half of the participants were inculded in cntrol group and the other half as interventional study group. 4 Intraoperative sedation and analgesia. Intervention group: intervention Group will be administered 1µg/kg dexmedetomidine hydrochloride intravenously over 10 min as a bolus just before the induction in addition to the standard anaesthesia protocol, followed by maintenance dose of 0.5 μg/kg/hr. till the end of surgery.. No - There is not a plan to make this available Justification or reason for not sharing IPD is there is no further information
public Brig (R) Dr Akbar Waheed
276 Peshawer Road
Rawalpindi Pakistan 46000 +92 51 9094111 akbar.waheed@riphah.edu.pk Islamic International Medical College and Wah medical college scientific Prof Dr Akbar Waheed Brig(R)
276 Peshawer Road
Rawalpindi Pakistan 46000 +92 51 111 510 510 akbar.waheed@riphah.edu.pk Islamic International Medical College Pakistan ASA I &II Pakistani origin no limit no limit Both No co-morbidity Non pregnant females U00-U85 Thr drug under study will be given as adjuvant to anesthesia to produce sedation and analgesia and reduce the dose of anesthetic agents, analgesic and drugs for neasea & vomiting. Treatment - Drugs Intervention group: intervention Group will be administered 1µg/kg dexmedetomidine hydrochloride intravenously over 10 min as a bolus just before the induction in addition to the standard anaesthesia protocol, followed by maintenance dose of 0.5 μg/kg/hr. till the end of surgery. Intraoperative sedation and analgesia. Timepoint: beore interventiona and at 1/2 an hour interval and at 2hrs interval. Method of measurement: Ramsay Sedation scale, Visual analogue scale and polymorphism in genes. Genotyping and Polymorphism in Receptor gene and in enzyme gene. Timepoint: Polymorphism cam be studies both in control and study group in blood sample of 2hsr interval. Method of measurement: Drug concentration will be meausred at 30 min and at 2hrs interval in both groups. no Approved 2023-01-06 Intsitutional Review Committee (IRC) Islamic International Medical College 276, Peshawer Road Rawalpindi PUNJAB Pakistan