A Clinical Trial Of Oxycodone Combined With Propofol Target-controlled Infusion Sedation In Endoscopic Surgery For Patients With Pancreatic And Cholangiopancreatic Diseases

ObjectiveThe first part:Randomized double-blind comparison of sedation with low,medium and high doses of oxycodone combined with propofol TCI in ERCP for patients with pancreaticobiliary diseases,and to explore the appropriate compatible dose of oxycodone in sedation during ERCP.The second part:To explore the half effective concentration of propofol effector in combination with oxycodone to inhibit the endoscopic response of ERCP.MethodsThe first part:According to inclusion and exclusion criteria,120 non-elderly subjects who were diagnosed as pancreaticobiliary duct diseases and were scheduled to undergo endoscopic surgery in our hospital were selected and randomly divided into four groups?n=30?,sufentanil group?S group?,low-dose oxycodone group?L group?,medium-dose oxycodone group?M group?and high-dose oxycodone group?H group?.All subjects were sedated with propofol TCI.Five minutes before the start of sedation,0.08 mg/kg,0.1 mg/kg and 0.12 mg/kg oxycodone were intravenously administered to subjects in L,M and H groups,and 0.1 mg/kg sufentanil was intravenously administered to subjects in S group.Observed indicators:propofol Ce,MAP,HR,propofol consumption,duration of operation and recovery time of consciousness.Observation time:before sedation?O₁?,before endoscopy?O₂?,when endoscopy?O₃?,when endoscopy entered Oddi sphincter?O₄?.Record the whole course of the test:adverse reactions such as hypoxemia,low heart rate,hypotension,involuntary motor activity and PONV.The second part:According to inclusion and exclusion criteria,120 patients who were diagnosed as pancreaticobiliary duct diseases and were scheduled to undergo endoscopic surgery in our hospital were selected.They were divided into four groups according to age group?n=30?,namely youth group?A group?,middle-aged group?B group?,low-dose elderly group?C group?and middle-dose elderly group?D group?.All subjects were sedated with propofol TCI.Five minutes before the onset of sedation,0.1 mg/kg oxycodone was intravenously administered in group A,B and D,and 0.08 mg/kg oxycodone was intravenously administered in group C.Ce propofol began to increase from 1.0?g/ml.Ce₁ and Ce₂ were titrated with a fixed gradient of 0.2?g/ml.The sedation-related adverse events including hypotension,hypocardia and hypoxemia were recorded.ResultsThe first part:At O₂^O₄ time point,propofol Ce in group L was higher than that in other three groups,at O₃ and O₄ time point,MAP and HR in group L were higher than those in other three groups,there were significant difference?P<0.05?.The propofol consumption in group L was higher than that in other three groups,while propofol consumption in group H was lower than that in other three groups,there were significant difference?P<0.05?.The recovery time of consciousness in group H was longer than that in other three groups?P<0.05?.There was no significant difference in the incidence of sedation-related adverse events between the four groups?P>0.05?.The second part:The EC50?95%CI?of propofol in group A,B,C and D were3.50?3.42-3.57?,3.41?3.33-3.45?,3.12?3.04-3.19?and 3.09?3.01-3.16??g/ml respectively.Compared with group A or B,EC50 of propofol in group C and D with negative endoscopy reaction decreased significantly.There was no significant difference in EC50 of propofol in group A and group B,and no significant difference in EC50 of propofol in group C and group D.The Pearson correlation coefficients of group A,B,C and D were 0.66,0.86,0.81 and 0.77 respectively.There was no significant difference in the incidence of adverse events such as hypotension,low heart rate and hypoxemia among the four groups?P>0.05?.Conclusion1.Intravenous 0.1 mg/kg oxycodone combined with propofol TCI can achieve satisfactory sedative effect and lower incidence of adverse events in ERCP for non-elderly patients.2.Compared with non-elderly people,the propofol Effective Room Concentration ?ERCP?in elderly patients was significantly lower.3.When combined with 0.1mg/kg oxycodone,the EC50?95%CI?of young and middle-aged people were 3.50?3.42-3.57??g/ml and 3.41?3.33-3.45??g/ml,respectively.4.The recommended dose of oxycodone in elderly patients undergoing ERCP was 0.08mg/kg,and the EC50?95%CI?of propofol inhibiting endoscopic response was 3.12?3.04-3.19?ug/ml.5.In combination with oxycodone,there was a positive correlation between the effect site concentration required for propofol on loss of consciousness and negative endoscopic response.