Physostigmine After General Anesthesia

NCT ID: NCT00850850

Last Updated: 2010-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-05-31

Brief Summary

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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

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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.

Conditions

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Postoperative Nausea and Vomiting Anesthesia Recovery Period

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

physostigmine

Intervention Type DRUG

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.

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).

Group Type PLACEBO_COMPARATOR

Isotonic sodium chloride solution

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Fysostigmin; Methylcarbamate; Erserine; Eserolein NaCl

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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ICU

Principal Investigators

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Frank Pott, MD

Role: STUDY_DIRECTOR

Bispebjerg Hospital

Locations

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Bispebjerg Hospital

Copenhagen, Copenhagen NV, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Frank Pott, MD

Role: CONTACT

+4535313531 ext. 4358

Carsten M Pedersen, MSN

Role: CONTACT

+4535313983 ext. 4845

Facility Contacts

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Carsten M Pedersen, cand.cur.

Role: primary

+4535313983

Other Identifiers

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2006-002497-22

Identifier Type: -

Identifier Source: org_study_id

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