]>
IRCT2014052317651N1 IRCT 2014-06-12 Isfahan university of medical sciences, faculty of medicine effects of ketamine-fentanyl combination and propofol- remifentanil combination for sedation during Endoscopic retrograde cholangiopancreatography Assessment of the effects of ketamine-fentanyl combination versus propofol- remifentanil combination for sedation during Endoscopic retrograde cholangiopancreatography 2012-08-22 anticipated 62 Complete https://irct.ir/trial/16178 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive. N/A Disorders of gallbladder, biliary tract and pancreas. Intervention 1: Ketamine group will receive a loading dose of Ketamine 0.5 mg/Kg body weight intravenously over 60 seconds and then Fentanyl 1 mcg/Kg body weight intravenously. According to sedation level, in Ramsay sedation score(RSS) 1 and RSS2, the initial sedation will be inadequate and the repeated dose will be necessary to accomplish the procedure and additional incremental dose of Ketamine 0.2 mg/Kg body weight will be given intravenously to patient in Ketmine group. Intervention 2: Propofol group will receive Propofol l mg/Kg body weight intravenously over 60 seconds and then Remifentanil 0.05 mcg/Kg body weight/min intravenously. Intravenous infusion of propofol will be maintained by 50 mcg/Kg body weight/min throughout ERCP. In RSS1 and RSS2 the initial sedation will be inadequate and the repeated dose will be necessary to accomplish the procedure and intravenous infusion of propofol will be increased up to 100 µg/Kg body weight/min to patient in Propofol group.
public Sayed Morteza Heidari - Anaesthesiologist
Sofe Ave, Alzahra Hospital
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3668 5555 m_heidari@med.mui.ac.ir ; alzahra@mui.ac.ir Alzahra Hospital scientific Sayed Morteza Heidari - Anaesthesiologist
Sofe Ave, Alzahra Hospital
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3668 5555 m_heidari@med.mui.ac.ir ; alzahra@mui.ac.ir Alzahra Hospital Iran (Islamic Republic of) Inclusion Criteria: Patient at age between 25 to 70 years; ASA physical status I and II; Patients without anatomic airway abnormalities; Patients without severe cardiovascular and respiratory disease; Patients without severe psychological problem; Patients who are not pregnant; Patients who are not smoker or addict; Patients without history of previous ERCP. Exclusion criteria: Occurring severe ERCP complications such as perforation and bleeding; ERCP procedural failure; Changing the sedation plan to the general anesthesia. 25 years 70 years Both K87 Disorders of gallbladder, biliary tract and pancreas in diseases classified elsewhere Treatment - Drugs Treatment - Drugs Ketamine group will receive a loading dose of Ketamine 0.5 mg/Kg body weight intravenously over 60 seconds and then Fentanyl 1 mcg/Kg body weight intravenously. According to sedation level, in Ramsay sedation score(RSS) 1 and RSS2, the initial sedation will be inadequate and the repeated dose will be necessary to accomplish the procedure and additional incremental dose of Ketamine 0.2 mg/Kg body weight will be given intravenously to patient in Ketmine group. Propofol group will receive Propofol l mg/Kg body weight intravenously over 60 seconds and then Remifentanil 0.05 mcg/Kg body weight/min intravenously. Intravenous infusion of propofol will be maintained by 50 mcg/Kg body weight/min throughout ERCP. In RSS1 and RSS2 the initial sedation will be inadequate and the repeated dose will be necessary to accomplish the procedure and intravenous infusion of propofol will be increased up to 100 µg/Kg body weight/min to patient in Propofol group. Sedation level. Timepoint: every 5 min during the first 15 min of the procedure and then every 15 min until the end of procedure. Method of measurement: Ramsay scale. Dose repeats. Timepoint: during ERCP. Method of measurement: Questionnaire. Recovery time. Timepoint: after procedure. Method of measurement: Aldrete score. Systolic blood pressure. Timepoint: before the intervention then every 5 min during the first 15 min of the procedure and then every 15 min until the end of procedure and then at the entrance to the recovery room and after first 15 min. Method of measurement: sphygmomanomete. Heart rate. Timepoint: before the intervention then every 5 min during the first 15 min of the procedure and then every 15 min until the end of procedure and then at the entrance to the recovery room and after first 15 min. Method of measurement: Beat/minute. O2 saturation. Timepoint: before the intervention then every 5 min during the first 15 min of the procedure and then every 15 min until the end of procedure and then at the entrance to the recovery room and after first 15 min. Method of measurement: Pulse oximetry. Respiratory rate. Timepoint: before the intervention then every 5 min during the first 15 min of the procedure and then every 15 min until the end of procedure and then at the entrance to the recovery room and after first 15 min. Method of measurement: per minute. Retching. Timepoint: during ERCP. Method of measurement: Questionnaire. Apnea occurrence. Timepoint: during ERCP. Method of measurement: Questionnaire. Patient’s pain intensity. Timepoint: at 60 min post procedure. Method of measurement: Visual analogue scale(VAS). Patient’s satisfaction. Timepoint: after procedure. Method of measurement: Visual analogue scale(VAS). Intensity of nausea. Timepoint: at 60 min post procedure. Method of measurement: Visual analogue scale(VAS). Endoscopist’s satisfaction. Timepoint: after procedure. Method of measurement: Visual analogue scale(VAS). Isfahan university of medical sciences, faculty of medicine Approved 2011-11-09 Isfahan university of medical sciences, faculty of medicine Isfahan university of medical sciences, faculty of medicine Hezarjerib Ave, Azadi square Isfahan Iran (Islamic Republic of)