Chronic Pain Clinical Trial
Official title:
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
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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