Physostigmine After General Anesthesia

May 26, 2010 updated by: Bispebjerg Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen NV
      • Copenhagen, Copenhagen NV, Denmark, 2400
        • Recruiting
        • Bispebjerg hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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 Names:
  • Fysostigmin; Methylcarbamate; Erserine; Eserolein
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).
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 Names:
  • NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
60 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Study Director: Frank Pott, MD, Bispebjerg hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

March 1, 2011

Study Completion (Anticipated)

May 1, 2011

Study Registration Dates

First Submitted

February 24, 2009

First Submitted That Met QC Criteria

February 24, 2009

First Posted (Estimate)

February 25, 2009

Study Record Updates

Last Update Posted (Estimate)

May 27, 2010

Last Update Submitted That Met QC Criteria

May 26, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-002497-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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