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
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|
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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
- 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 ]
- 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 ]
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
|Contact: Frank Pott, MD||+4535313531 ext email@example.com|
|Contact: Carsten M Pedersen, MSN||+4535313983 ext firstname.lastname@example.org|
|Copenhagen, Copenhagen NV, Denmark, 2400|
|Contact: Carsten M Pedersen, cand.cur. +4535313983 email@example.com|
|Study Director:||Frank Pott, MD||Bispebjerg Hospital|