Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP) With or Without Opioids
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Addition of fentanyl or remifentanil to the propofol produced sedation for scheduled ERCP
      will decrease the propofol requirements for predetermined sedation levels (as shown by
      Bispectral Index Monitor (BIS) monitor), will be associated with faster recovery monitored by
      Ramsay's and Observer's Assessment of Alertness/Sedation (OAAS) scores and BIS, less
      postoperative pain (assessed by Visual Analogue Scale=VAS) and less early cognitive
      impairment after sedation (as assessed by the MiniMental test).
    

Detailed description: 
      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.

      Anesthetic technique Before opioid/placebo/anesthetic administration all patients receive for
      3-5 min 100% oxygen via a face mask from a wall oxygen source by means of a Mapleson C
      breathing system. Two venous catheters are inserted in peripheral veins and connected via
      extension tubes to two separate infusion pumps for remifentanil or placebo and for propofol
      infusion.

      Basic monitoring includes pulse oximetry, non-invasive blood pressure (measured in the
      beginning and at the end of the procedure), heart rate, respiratory rate and ECG. Additional
      monitoring includes BIS, (BIS VIEW ™ Monitoring System, Aspect Medical Systems, Inc. One
      Upland Road Norwood, MA 02062 USA). All patients are preoxygenated with 100% oxygen via a
      face mask before anesthetic administration. During the procedure oxygen (9 l/min) is
      administered via a nasal catheter. Sedation/anesthesia is maintained with propofol bolus 1
      mg/kg to begin with, plus infusion (5-9 mg/kg/h) by means of an electric pump to obtain BIS
      values around 40-70.

      Intraoperative variables to be recorded Baseline values (before starting opioid/placebo) and
      every 3 min thereafter throughout the procedure BIS, SpO2, HR, RR, and Movement of the
      patient (Yes/No) are recorded and the propofol infusion is increased accordingly. Systolic
      and diastolic blood pressure is recorded in the beginning and at the end of the procedure
      (not to disturb the patient and change the level of consciousness, except for complications
      during the procedure like bleeding, apnea etc). Also events of desaturation (SpO2 below 90),
      episodes of apnea (apnea for > than 30s), and other adverse events are recorded. Systolic and
      diastolic blood pressure is recorded in the beginning and at the end of the procedure (not to
      disturb the patient and change the level of consciousness, except for complications during
      the procedure, like bleeding, apnea etc).

      At the end of the procedure the total doses of propofol and remifentanil (or the volume of
      placebo) are recorded.
    

Intervention name(s): Remifentanil; Fentanyl; Normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 microgram/kg/h, continuous infusion, 5 min before and during the ERCP; Intranasal fentanyl 200 micrograms 5 min before the ERCP; Normal saline intravenously and intranasally
Other intervention name(s): Ultiva
Intervention MeSH terms: Fentanyl; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Propofol; remifentanil; fentanyl; ERCP; Quality of sedation; recovery; satisfaction; respiratory depression