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IRCT20221109056455N2 IRCT 2024-09-26 Tata Main Hospital, Jamshedpur Intravenous Dexmedetomidine versus Nebulised Dexmedetomidine for procedural sedation during ERCP Intravenous Dexmedetomidine versus Nebulised Dexmedetomidine in combination with standardised Propofol-Fentanyl-Midazolam for Procedural sedation during ERCP: a comparative evaluation of sedation efficacy 2024-10-01 anticipated 70 Complete https://irct.ir/trial/78424 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 1. A list of participants will be created in spreadsheet/excel sheet 2. Generate random numbers in next column using excel formula. 3. Sort the list based on the random numbers. 4. Assign the first half of participants to Group A and the second half to Group B. 5. Sealed envelop with serial numbers on it with allocation sealed inside, will be applied to ensure blinding and confidentiality of group assignment, Blinding description: The administration of intravenous and nebulised Dexmedetomidine is done by different personnel neither involved in study nor procedure sedation to prevent bias. Randomly assign participants to either the intravenous or nebulised Dexmedetomidine group using a randomization table or software. Administration of medication will be done in pre op area. Anaesthesia management will be done by anaesthesiologist not related to study, using Midazolam- Fentanyl- Propofol combination. All parameters/outcome will be recorded by caregiver anaesthesiologist in proforma. Investigator will collect proforma at the end of procedure for data extraction and analysis. Bioequivalence choledocholithiasis with obstruction. Intervention 1: Intervention group: Group NEB-DEX will receive nebulized dexmedetomidine 1 µg/kg diluted in normal saline (0.9%) to a volume of 5 ml 30 minutes prior to induction of anesthesia. Intervention 2: Control group: Group IVDEX will receive iv dexmedetomidine 1 mcg/kg diluted in normal saline over 10 minutes 30 minutes prior to induction of anesthesia. 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 Participants' patient individual data is under the ownership of the hospital. It will be made available on request after no objection from the Hospital authority. Study-related data, informed consent, and data set will be published in open access journals with raw data set to be made available on request with justification after no objection from institutional authority.
public Dr Rishi Anand
road C, northern town, Bistupur
Jamshedpur India 831001 +91 97165 48587 rishi.anand1@tatasteel.com Tata Main Hospital, Jamshedpur scientific Dr Rishi Anand
road C, northern town, Bistupur
Jamshedpur India 831001 +91 97165 48587 rishi.anand1@tatasteel.com Tata Main Hospital, Jamshedpur India Patient undergoing procedural sedation for Endoscopic retrograde cholangio- pancreaticography ASA physical status 1- 3 AGE 18-65 Years 18 years 65 years Both Patient refusal allergy to study drugs Heart rate less than 50/minute Patient on beta blockers Hemodynamically unstable or shock. oxygen saturation less than 95 % on room air Hepatic or renal failure Second degree or third degree heart block BMI > 36 kg/m2 K80.81 Other cholelithiasis with obstruction Treatment - Drugs Treatment - Drugs Intervention group: Group NEB-DEX will receive nebulized dexmedetomidine 1 µg/kg diluted in normal saline (0.9%) to a volume of 5 ml 30 minutes prior to induction of anesthesia Control group: Group IVDEX will receive iv dexmedetomidine 1 mcg/kg diluted in normal saline over 10 minutes 30 minutes prior to induction of anesthesia Propofol consumption per unit time. Timepoint: At the end of procedure. Method of measurement: Propofol consumption will be calculated by sum of amount consumed by infusion and rescue bolus doses of propofol. It will be divided by duration of infusion to calculate per unit time propofol consumption. Patient satisfaction score. Timepoint: at the end of procedure. Method of measurement: Patient satisfaction will be assessed using 5 point Gloucester Comfort Score. Incidence of Adverse event( Desaturation, hypotension and bradycardia). Timepoint: At the end of procedure. Method of measurement: Hypotension will be defined by blood pressure falling more than 20 % of baseline as measured by sphygmomanometer. Bradycardia will be counted if heart rate is less than 50 during the procedure. If saturation fall below 95 during procedure, it will be counted as desaturation episode. Tata Main Hospital, Jamshedpur Approved 2024-07-12 Institutional Ethics Committee Tata Main Hospital, Jamshedpur Road C, Northern town, Bistupur, Jamshedpur Jamshedpur Jharkhand India