Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001229965
Ethics application status
Approved
Date submitted
29/11/2011
Date registered
30/11/2011
Date last updated
30/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Penehyclidine Hydrochloride reduces the incidence of intraoperative awareness
Scientific title
Penehyclidine Hydrochloride reduces the incidence of intraoperative awareness in patients undergoing breast cancer surgery during general anesthesia
Secondary ID [1] 273489 0
Nil
Universal Trial Number (UTN)
U1111-1126-1353
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 279277 0
awareness during surgery 279291 0
Condition category
Condition code
Anaesthesiology 279475 279475 0 0
Anaesthetics
Cancer 279487 279487 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients receive 0.01 mg.kg-1 Penehyclidine Hydrochloride intravenously 30min before surgery
Intervention code [1] 283804 0
Treatment: Drugs
Comparator / control treatment
Patients receive 0.01 mg.kg-1 saline intravenously 30min before surgery
Control group
Placebo

Outcomes
Primary outcome [1] 286043 0
Penehyclidine Hydrochloride reduces the incidence of intraoperative awareness in patients undergoing breast cancer surgery during general anesthesia.
Timepoint [1] 286043 0
Every Patient was interviewed twice, at anytime between 2 and 6 hours postoperatively and at any time between 24 and 48 hours postoperatively.
Secondary outcome [1] 295031 0
Patients with higher degree anxiety levels were liable to report intraoperative awareness.
Timepoint [1] 295031 0
Before they received Penehyclidine Hydrochloride or saline, the patients were assessed preoperative anxiety levels by using a 100-mm visual analogue scale.

Eligibility
Key inclusion criteria
American Society of Anesthesiologists physical status I–III patients, aged 15–75 years, undergoing breast cancer surgery
Minimum age
15 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
psychosis or memory impairment, history of intraoperative awareness or brain injury, history of electroencephalographic abnormality, patients habitually using benzodiazepines, opiates, alcohol, barbiturates, carbamazepine, glucocorticoids, phenytoin and rifampicin etc. and patients who are unable to provide informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment was established by placing the randomization sequence in consecutively numbered, opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment outside Australia
Country [1] 3983 0
China
State/province [1] 3983 0

Funding & Sponsors
Funding source category [1] 284280 0
Hospital
Name [1] 284280 0
Fudan University Cancer Hospital
Country [1] 284280 0
China
Primary sponsor type
Individual
Name
Zhiming Tan
Address
Department of Anesthesiology, Fudan University Cancer Hospital, No.270 Dong-an Road, Shanghai, P. R. China
Country
China
Secondary sponsor category [1] 283231 0
Individual
Name [1] 283231 0
Jing wang
Address [1] 283231 0
Department of Anesthesiology, Fudan University Cancer Hospital, No.270 Dong-an Road, Shanghai, P. R. China
Country [1] 283231 0
China
Other collaborator category [1] 260361 0
Individual
Name [1] 260361 0
Yu Ren,Minmin Zhu,Yun Zhu,Jiawei Chen,Yajun Xu
Address [1] 260361 0
Department of Anesthesiology, Fudan University Cancer Hospital, No.270 Dong-an Road, Shanghai, P. R. China
Country [1] 260361 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286239 0
the Cancer Hospital, Fudan University Institutional Human Ethics Committee
Ethics committee address [1] 286239 0
No.270 Dong-an Road, Shanghai, P. R. China,PC 200032.
Ethics committee country [1] 286239 0
China
Date submitted for ethics approval [1] 286239 0
23/11/2009
Approval date [1] 286239 0
20/01/2010
Ethics approval number [1] 286239 0
YJ200906

Summary
Brief summary
Extensive evidence has proved that basal forebrain cholinergic system play extremely important role in explicit memory.Penehyclidine hydrochloride (PHC; (2-hydroxyl-2-cyclopentyl-2-phenyl-ethoxy) quinuclidine) is a new anticholinergic drug with both antimuscarinic and antinicotinic activity while retaining potent central and peripheral anticholinergic activity.The primary purpose of this study is to verify the effectiveness of PHC reducing the incidence of intraoperative awareness. Modified Brice interview was used to assess awareness in the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33457 0
Address 33457 0
Country 33457 0
Phone 33457 0
Fax 33457 0
Email 33457 0
Contact person for public queries
Name 16704 0
YuRen
Address 16704 0
Department of Anesthesiology, Fudan University Cancer Hospital, No.270 Dong-an Road, Shanghai, P. R. China, PC 200032.
Country 16704 0
China
Phone 16704 0
86-21-64175590(for Shanghai ,China)
Fax 16704 0
Email 16704 0
[email protected]
Contact person for scientific queries
Name 7632 0
Zhiming Tan
Address 7632 0
Department of Anesthesiology, Fudan University Cancer Hospital, No.270 Dong-an Road, Shanghai, P. R. China, PC 200032.
Country 7632 0
China
Phone 7632 0
86-21-64175590(for Shanghai ,China)
Fax 7632 0
Email 7632 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.