Unit:
Faculty of MedicineLibrary of the School of Health Sciences
Dissertation committee:
Αργυρώ Φασουλάκη, Ομότιμη Καθηγήτρια, Ιατρική Σχολή, ΕΚΠΑ
Ανδρέας Πολυδώρου, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Άντεια Παρασκευά, Αναπληρώτρια Καθηγήτρια, Ιατρική Σχολή, ΕΚΠΑ
Κασσιανή Θεοδωράκη, Καθηγήτρια, Ιατρική Σχολή, ΕΚΠΑ
Αθανασία Τσαρούχα - Δημητροπούλου, Αναπληρώτρια Καθηγήτρια, Ιατρική Σχολή, ΕΚΠΑ
Αντώνιος Βεζάκης, Αναπληρωτής Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Χρυσάνθη Μπατιστάκη, Αναπληρώτρια Καθηγήτρια, Ιατρική Σχολή, ΕΚΠΑ
Original Title:
Βαθιά καταστολή για ενδοσκοπική χολαγγειοπαγκρεατογραφία με ή χωρίς τη χρήση οπιοειδών
Translated title:
Deep sedation for endoscopic cholangiopancreatography with or without opioids
Summary:
The demand for sedation and analgesia, in procedures outside the operation
room, has increased exponentially along with the increase in both the number and the
complexity of these procedures. For this purpose, a combination of various drugs is
used. In recent years the administration of propofol alone or in combination with
opioids has become particularly popular practice for sedation outside the operation
room.
Purpose: The aim of the present study was to investigate the effect of pre or
intraprocedural opioids on propofol requirements during deep sedation for Endoscopic
Retrograde Cholangiopancreatography (ERCP), and on recovery, pain, and cognitive
function postoperatively.
Material and method: This was a single-center, placebo-controlled, double-
blinded randomized trial with three parallel groups. 180 patients participated in the
study, aged between 45 and 75 years, assigned randomly to three groups (60 patients
in each group). All patients received propofol for deep sedation [target Bispectral Index
(BIS) 40 to 70]. In the remifentanil group (R), the patients received intranasal placebo
before ERCP while remifentanil infusion (concentration 10μg/ml) was administrated at
a rate of 0,1ml/kg/h during ERCP. In fentanyl group (F), the patients received
intranasal fentanyl 200 μg before ERCP, and placebo infusion during ERCP. In
placebo group (P), the patients received intranasal placebo before ERCP and placebo
infusion at a rate of 0,1ml/kg/h during ERCP .The primary outcome documentation
was the total porpofol requirements. Secondary outcomes were recovery [using the
Ramsay Sedation Scale Score and Observer’s Assessment of Alertness/Sedation
Score (OAAS)], postoperative pain [measured by the visual analogue scale (VAS) 0
to 100mm]}, both assessed 30 min after ERCP and cognitive function [using a Mini
Mental state test (max. 25 points) and assessed 30 min before and 30 min after
ERCP].
Results: 57 patients were analyzed in group R, 59 in group F, and 57 in group
P. Propofol requirements for deep sedation were similar in all groups. (13mg/kg: P=
0,97). There was no difference in recovery- Ramsay Sedation Scale scores and
(OAAS) scores were similar in all groups (P=0,18 και P=0,55, respectively). The
incidence of postoperative pain was different-statistically significant-among the groups
(P=0,007). The median VAS (scale 100) scores were 10 in group R, 0 in group F, 5 in
group P. The cognitive function was assessed high pre and postprocedural (median
Mini Mental State Test 23/25 to 24/25) and not different among the groups.
Conclusion: The addition of pre or intraprocedural opioids had no effect on
propofol requirements for deep sedation, but patients who received IN fentanyl had
less involuntary reactions during ERCP (P=0,032) and minor pain after the procedure
(P =0,007)).
Main subject category:
Health Sciences
Keywords:
Sedation outside operation room, ERCP, Propofol, Remifentanil, Fentanyl, BIS, Cognitive function, Recovery
Number of references:
223
