Back to resultsPhysostigmine After General Anesthesia
Primary Purpose
Postoperative Nausea and Vomiting, Anesthesia Recovery Period
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
physostigmine
Isotonic sodium chloride solution
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring PACU, Physostigmine, Recovery, Postanesthesia Nursing, Wakefulness, General anesthesia, General Anesthetics, Postoperative Period
Eligibility 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
Sites / Locations
- Bispebjerg HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Physostigmine
NaCl
Arm Description
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.
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).
Outcomes
Primary Outcome 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
Secondary Outcome 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00850850
Brief Title
Physostigmine After General Anesthesia
Official Title
The Use of Physostigmine in Elderly Patients in the Postoperative Recovery-phase After General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
May 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting, Anesthesia Recovery Period
Keywords
PACU, Physostigmine, Recovery, Postanesthesia Nursing, Wakefulness, General anesthesia, General Anesthetics, Postoperative Period
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physostigmine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
NaCl
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
physostigmine
Other Intervention Name(s)
Fysostigmin; Methylcarbamate; Erserine; Eserolein
Intervention Description
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
Intervention Name(s)
Isotonic sodium chloride solution
Other Intervention Name(s)
NaCl
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Pott, MD
Phone
+4535313531
Ext
4358
Email
frank.pott@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Carsten M Pedersen, MSN
Phone
+4535313983
Ext
4845
Email
carstenmp@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Pott, MD
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
State/Province
Copenhagen NV
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carsten M Pedersen, cand.cur.
Phone
+4535313983
Email
cped0070@bbh.regionh.dk
12. IPD Sharing Statement
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Physostigmine After General Anesthesia
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