Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000964819
Ethics application status
Approved
Date submitted
7/06/2012
Date registered
7/09/2012
Date last updated
7/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of dexmedetomidine combined with propofol for conscious sedation during endoscopic retrograde cholangiopancreatography(ERCP)
Scientific title
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.
Secondary ID [1] 280640 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Although target controlled infusion(TCI) systems decrease the risk of respiratory during sedation with propofol, the risk persists. 286652 0
Condition category
Condition code
Anaesthesiology 286942 286942 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 285036 0
Treatment: Drugs
Comparator / control treatment
Propofol for sedation. This is typically used via a "target-controlled-infusion" pump which calculates the patients' estimated plasma concentration of propofol using computerised models. 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). This is titrated to effect. It would also be given via intravenous infusion commencing once the patient is positioned, and also not combined with other sedative agents.
Control group
Active

Outcomes
Primary outcome [1] 287290 0
The sedation level was assessed by the Richmond alertness-sedation scale and bispectral index(BIS), and the demand for additional sedatives.
Timepoint [1] 287290 0
Intraoperative (less than three hours)
Secondary outcome [1] 297842 0
Heart rate, blood pressure, oxygen saturation, and respi-
ratory rate were recorded by cardiogram monitor (SK26-PC-9000C, China) before anesthesia, every 5 minutes during anesthesia, and 10 minutes after anesthesia, these will be recorded on the worksheet . The results will be compared between the two groups using variance analysis
by SPSS.
Timepoint [1] 297842 0
Intraoperative (less than three hours)

Eligibility
Key inclusion criteria
Adults without intubations undergoing ERCP
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any contraindication to sedation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolling - discussed with patient prior to surgery and formal consent obtained on or before day of surgery. Clinicians will contact the anaesthetic department who will hold the allocation sequence. Departmental staff will inform the clinicians of assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised block registration.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 285405 0
Self funded/Unfunded
Name [1] 285405 0
Dr Qianbo Chen
Country [1] 285405 0
China
Primary sponsor type
Individual
Name
Dr Qianbo Chen
Address
Department of Anesthesiology
Eastern Hepatobiliary Surgery Hospital
Second Military Medical University
225 Changhai Rd
Shanghai
200438
Country
China
Secondary sponsor category [1] 284257 0
None
Name [1] 284257 0
Address [1] 284257 0
Country [1] 284257 0
Other collaborator category [1] 276855 0
Individual
Name [1] 276855 0
Dr Weifeng Yu
Address [1] 276855 0
Department of Anesthesiology
Eastern Hepatobiliary Surgery Hospital
Second Military Medical University
225 Changhai Rd
Shanghai
200438
Country [1] 276855 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287422 0
Ethics Committee of Eastern Hepatobiliary Hospital
Ethics committee address [1] 287422 0
Department of Anesthesiology
Eastern Hepatobiliary Surgery Hospital
Second Military Medical University
225 Changhai Rd
Shanghai
200438
Ethics committee country [1] 287422 0
China
Date submitted for ethics approval [1] 287422 0
Approval date [1] 287422 0
Ethics approval number [1] 287422 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34285 0
Address 34285 0
Country 34285 0
Phone 34285 0
Fax 34285 0
Email 34285 0
Contact person for public queries
Name 17532 0
Dr Qianbo Chen
Address 17532 0
Department of Anesthesiology
Eastern Hepatobiliary Surgery Hospital
Second Military Medical University
225 Changhai Rd
Shanghai
200438
Country 17532 0
China
Phone 17532 0
+8613774288357
Fax 17532 0
Email 17532 0
[email protected]
Contact person for scientific queries
Name 8460 0
Dr Qianbo Chen
Address 8460 0
Department of Anesthesiology
Eastern Hepatobiliary Surgery Hospital
Second Military Medical University
225 Changhai Rd
Shanghai
200438
Country 8460 0
China
Phone 8460 0
+8613774288357
Fax 8460 0
Email 8460 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.