RecruitingPhase 4ACTRN12612000964819

A comparison of dexmedetomidine combined with propofol for conscious sedation during endoscopic retrograde cholangiopancreatography(ERCP)

A comparison of dexmedetomidine combined with propofol for conscious sedation during endoscopic retrograde cholangiopancreatography(ERCP), in adults without intubations , assessing patients satisfaction and respiratory and cardiovascular stability.


Sponsor

Dr Qianbo Chen

Enrollment

60 participants

Start Date

Jun 4, 2012

Study Type

Interventional

Conditions

Summary

This trial will compare the sedative medicine dexmedetomidine and propofol with propofol. The comparison will take place in a group of patients undergoing ERCP without intubations. Although TCI systems decrease the risk of respiratory during sedation with propofol in the patients undergoing ERCP, the risk persists. Propofol has some side effects including reduced breathing efforts, which sometimes requires the anaesthetist to intervene and support the airway or even convert the sedation to a general anesthesia with intubations. Dexmedetomidine as a newer sedative medicine, appears to have fewer of these effects and reduce the total amount of propofol. Patients will be randomized to receive either propofol or dexmedetomidine combined with propofol. They will receive their normal general anesthesia without intubations. The researchers will be measuring: the target concentration of propofol in maintain anesthesia and the total amount of propofol during the surgery; need for airway support; and haemodynamic values intraoperatively.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two sedation approaches for patients having a procedure called ERCP (a scope procedure used to examine and treat problems in the bile ducts and pancreas). One group will receive propofol alone (the standard sedative), and the other will receive a combination of propofol and dexmedetomidine, a newer sedative that may reduce the amount of propofol needed and lower the risk of breathing problems. Researchers will track how much medication is needed and whether any breathing support is required during the procedure. You may be eligible if: - You are 18 years or older - You are scheduled to have an ERCP procedure without a breathing tube (non-intubated sedation) - You do not have any known contraindications to sedation You may NOT be eligible if: - You have a condition that makes sedation unsafe or contraindicated - You require general anesthesia with intubation for the procedure Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The intervention will be usage of dexmedetomidine combined with propofol for sedation during ERCP. Dosages of dexmedetomidine is introduction with a loading dose of 1.0 micrograms per kilogram in ten

The intervention will be usage of dexmedetomidine combined with propofol for sedation during ERCP. Dosages of dexmedetomidine is introduction with a loading dose of 1.0 micrograms per kilogram in ten minutes (eg. 60micrograms for an 60kg patient). While propofol is typically used via a "target-controlled-infusion" pump with an initial target concentration set at 4ug/ml (target concentration ranging between 1 and 4ug/ml). The two drugs would be given via intravenous infusion, commencing once the patient is positioned and it would not be combined with other sedative agents.


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ACTRN12612000964819