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Physostigmine After General Anesthesia

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ClinicalTrials.gov Identifier: NCT00850850
Recruitment Status : Unknown
Verified May 2010 by Bispebjerg Hospital.
Recruitment status was:  Recruiting
First Posted : February 25, 2009
Last Update Posted : May 27, 2010
Sponsor:
Information provided by:
Bispebjerg Hospital

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.


Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Anesthesia Recovery Period Drug: physostigmine Drug: Isotonic sodium chloride solution Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Physostigmine in Elderly Patients in the Postoperative Recovery-phase After General Anesthesia
Study Start Date : December 2009
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


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 Name: 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 Name: NaCl




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850850


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

Locations
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Denmark
Bispebjerg Hospital Recruiting
Copenhagen, Copenhagen NV, Denmark, 2400
Contact: Carsten M Pedersen, cand.cur.    +4535313983    cped0070@bbh.regionh.dk   
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
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Study Director: Frank Pott, MD Bispebjerg Hospital

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Responsible Party: Frank Pott, ICU
ClinicalTrials.gov Identifier: NCT00850850     History of Changes
Other Study ID Numbers: 2006-002497-22
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: May 27, 2010
Last Verified: May 2010
Keywords provided by Bispebjerg Hospital:
PACU
Physostigmine
Recovery
Postanesthesia Nursing
Wakefulness
General anesthesia
General Anesthetics
Postoperative Period
Additional relevant MeSH terms:
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Vomiting
Postoperative Nausea and Vomiting
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Anesthetics
Physostigmine
Central Nervous System Depressants
Physiological Effects of Drugs
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Miotics
Autonomic Agents
Peripheral Nervous System Agents