Physostigmine After General Anesthesia

Sponsor

Bispebjerg Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00850850

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting Anesthesia Recovery Period	Drug: physostigmine Drug: Isotonic sodium chloride solution	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Dec 1, 2009

Anticipated Primary Completion Date :

Mar 1, 2011

Anticipated Study Completion Date :

May 1, 2011

Arms and Interventions

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 Names: 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 Names: NaCl

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 Names:

Fysostigmin; Methylcarbamate; Erserine; Eserolein

Placebo Comparator: NaCl

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 Names:

NaCl

Outcome Measures

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 [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 [6 hours]