Physostigmine After General Anesthesia

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2010 by Bispebjerg Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Bispebjerg Hospital

ClinicalTrials.gov Identifier:

NCT00850850

First received: February 24, 2009

Last updated: May 26, 2010

Last verified: May 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 24, 2009

Last Updated Date

May 26, 2010

Start Date ^ICMJE

December 2009

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The readiness to be released from the PACU (assessed by the normal guidelines) It should be noted that for safety reasons the patients remained in the PACU for at least 60 minutes [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00850850 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pain, shivering and nausea will also be registered on the standardized form as well as a multiple of physiological measurements. A follow-up will be performed after 12 hours from release from the PACU [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Physostigmine After General Anesthesia

Official Title ^ICMJE

The Use of Physostigmine in Elderly Patients in the Postoperative Recovery-phase After General Anesthesia

Brief Summary

Recovery after general anaesthesia is often prolonged in the elderly. This group is particularly exposed to post-operative confusion. This has negative personal consequences as well as consequences for the postoperative care for these patients.

The hypothesis is that physostigmine will decrease the amount of time in the post-anaesthesia care unit (PACU ), the postoperative amount of pain and shivering and finally post-operative confusion.

Detailed Description

The researchers wish to investigate the use of physostigmine in the elderly patients (age > 60 yrs, ASA I-III) in the postoperative recovery-phase after general anesthesia.

Apart from the beneficial effects for the patient, the lessened amount of time in the PACU will release caregiving resources and thereby increase the efficacy of the PACU.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Postoperative Nausea and Vomiting
Anesthesia Recovery Period

Intervention ^ICMJE

Drug: physostigmine
1 mg of physostigmine time 0 min. If the condition persisted after 15 min. the same amount of active drug would be administered once again.

Other Name: Fysostigmin; Methylcarbamate; Erserine; Eserolein
Drug: Isotonic sodium chloride solution
Patients who have difficulties in awakening from the general anaesthesia and do not suffer from excess nausea or vomiting will be randomised to receive 1 ml of isotonic sodium chloride solution (placebo) time 0 min. If the condition persisted after 15 min. the same amount of non-active drug would be administered once again.

Other Name: NaCl

Study Arm (s)

Active Comparator: Physostigmine
Patients who have difficulties in awakening from the general anaesthesia and do not suffer from excess nausea or vomiting will be randomised to receive 1 mg of physostigmine.

Intervention: Drug: physostigmine
Placebo Comparator: NaCl
Patients who have difficulties in awakening from the general anaesthesia and do not suffer from excess nausea or vomiting will be randomised to receive 1 ml of isotonic sodium chloride solution (placebo).

Intervention: Drug: Isotonic sodium chloride solution

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2011

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Scheduled for surgical acute or elective operation
General anesthesia.
ASA physical status I-III
Age > 60 years

Exclusion Criteria:

Asthma and chronic pulmonary diseases
Glaucoma
Diabetics
Any history of neurological and psychiatric disorder
Parkinson's disease
Disorders of the gastrointestinal and urogenital tracts

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Frank Pott, MD	+4535313531 ext 4358	frank.pott@gmail.com
Contact: Carsten M Pedersen, MSN	+4535313983 ext 4845	carstenmp@hotmail.com

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00850850

Other Study ID Numbers ^ICMJE

2006-002497-22

Has Data Monitoring Committee

Yes

Responsible Party

Frank Pott, ICU

Study Sponsor ^ICMJE

Bispebjerg Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Frank Pott, MD

Bispebjerg Hospital

Information Provided By

Bispebjerg Hospital

Verification Date

May 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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