Penehyclidine Hydrochloride reduces the incidence of intraoperative awareness

Penehyclidine Hydrochloride reduces the incidence of intraoperative awareness in patients undergoing breast cancer surgery during general anesthesia

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001229965

Enrollment

900

Registered

2011-11-30

Start date

2010-01-21

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

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.

Interventions

Patients receive 0.01 mg.kg-1 Penehyclidine Hydrochloride intravenously 30min before surgery

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

15 Years to 75 Years

Healthy volunteers

Inclusion criteria

American Society of Anesthesiologists physical status I–III patients, aged 15–75 years, undergoing breast cancer surgery

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.

Outcome results