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.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000964819

Enrollment

Registered

2012-09-07

Start date

2012-06-04

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Adults without intubations undergoing ERCP

Exclusion criteria

Any contraindication to sedation.

Outcome results