Physostigmine After General Anesthesia

Overview

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.

Full Title of Study: “The Use of Physostigmine in Elderly Patients in the Postoperative Recovery-phase After General Anesthesia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2011

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.

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bispebjerg Hospital
  • Provider of Information About this Clinical Study
    • Frank Pott, ICU
  • Overall Official(s)
    • Frank Pott, MD, Study Director, Bispebjerg Hospital
  • Overall Contact(s)
    • Frank Pott, MD, +4535313531, frank.pott@gmail.com

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