The Effect of Intranasal Fentanyl Versus Remifentanil Infusion on Propofol Requirements During Elective Therapeutic ERCP, as Well on the Recovery, Pain, and Early Cognitive Function: A Randomized Control Trial

Patients After obtaining approval from the Institutional Review Board (IRB) adult patients ASA I-III aged between 45 and 75 yrs scheduled for elective therapeutic ERCP are enrolled in the study. All patients are informed and asked to give written informed consent. Those with chronic pain, consuming opioids or other analgesics, sedatives, hypnotics, allergic to the drugs to be used in the study protocol, or patients who refuse to give written informed consent are excluded from the study.

Randomization and blindness Randomization was done by a Research Randomizer program, using 60 sets of numbers and 3 numbers per set for a total of 180 patients, keeping each number in a set to remain unique and without sorting the numbers that are generated. (http://www.randomizer.org/). The remifentanil or placebo solutions as well as the nasal fentanyl or placebo spray are prepared and administered by an independent investigator who is aware of the group randomization and indicated interventions.

Group 1: Receive remifentanil i.v infusion 1 ml/10 kg/h (10 μg/ml) starting 5 minutes before propofol administration and continued throughout the procedure. At the same time intranasal normal saline is given. A bolus dose of propofol 1 mg/kg is followed by propofol infusion and the infusion is titrated to obtain BIS values around 40-70.

Group 2: Receive normal saline i.v. infusion in volume equal to the volume of remifentanil as if he/she were assigned to Group 1, intranasal fentanyl 200 μg, and propofol as in group 1.

Group 3: Receive i.v. normal saline infusion in volume equal to the volume of remifentanil as if he/she were assigned to Group 1, intranasal normal saline, and propofol as in groups 1 and 2.