Trial Outcomes & Findings for Rivastigmine in the Treatment of Postoperative Delirium: a Pilot Clinical Trial (NCT NCT00835159)

NCT ID: NCT00835159

Last Updated: 2015-02-09

Results Overview

Is the incidence of POD not affected by rivastigmine treatment or not.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: 72 hours postoperatively
• Results posted on: 2015-02-09

Participant Flow

Patientsof 65years and older admitted for elective surgery undergeneral anesthesia were screened. Only patients at risk fordeveloping POD were considered for recruitment

This was a randomized, placebo controlled, double-blind clinical trial. Screened patients were 65 years +, having elective surgery under general anesthesia. Only patients at risk for POD were considered for recruitment. Eligible patients received rivastigmine 5cm2 transdermal or placebo patch. 30 patients recruited but only 28 had complete data.

Participant milestones

Measure	Rivastigmine 5-cm2 Transdermal Patch Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)\<24); (2) advanced age (\>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a rivastigmine 5-cm2 transdermal patch	Placebo Patch Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)\<24); (2) advanced age (\>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a placebo patch.
Overall Study STARTED	11	17
Overall Study COMPLETED	11	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rivastigmine in the Treatment of Postoperative Delirium: a Pilot Clinical Trial

Baseline characteristics by cohort

Measure	Rivastigmine 5-cm2 Transdermal Patch n=11 Participants Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)\<24); (2) advanced age (\>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a rivastigmine 5-cm2 transdermal patch	Placebo Patch n=17 Participants Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)\<24); (2) advanced age (\>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a placebo patch.	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	17 Participants n=7 Participants	28 Participants n=5 Participants
Age, Continuous	72.0909 years STANDARD_DEVIATION 5.55796 • n=5 Participants	72.6471 years STANDARD_DEVIATION 6.52822 • n=7 Participants	72.4286 years STANDARD_DEVIATION 6.06403 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	17 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 72 hours postoperatively

Is the incidence of POD not affected by rivastigmine treatment or not.

Outcome measures

Measure	Rivastigmine Patch n=11 Participants Eligible patients received a rivastigmine 5-cm2 transdermal patch	Placebo Patch n=17 Participants Eligible patients received a placebo patch
Incidence of POD	2 participants	4 participants

Adverse Events

Rivastigmine 5-cm2 Transdermal Patch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Patch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

ALEXANDER ZASLAVSKY

NYU Langone Medical Center

Phone: 212-263-5569

Email: michael.haile@nyumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place