NCT00850850

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 27, 2010

Status Verified

May 1, 2010

Enrollment Period

1.2 years

First QC Date

February 24, 2009

Last Update Submit

May 26, 2010

Conditions

Postoperative Nausea and VomitingAnesthesia Recovery Period

Keywords

PACUPhysostigmineRecoveryPostanesthesia NursingWakefulnessGeneral anesthesiaGeneral AnestheticsPostoperative Period

Outcome Measures

Primary Outcomes (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

    60 minutes

Secondary Outcomes (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

    6 hours

Study Arms (2)

Physostigmine

ACTIVE COMPARATOR

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

NaCl

PLACEBO COMPARATOR

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

Interventions

physostigmineDRUG

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.

Also known as: Fysostigmin; Methylcarbamate; Erserine; Eserolein
Physostigmine
Isotonic sodium chloride solutionDRUG

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.

Also known as: NaCl
NaCl

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for surgical acute or elective operation
  • General anesthesia.
  • ASA physical status I-III
  • Age \> 60 years

You may not qualify if:

  • Asthma and chronic pulmonary diseases
  • Glaucoma
  • Diabetics
  • Any history of neurological and psychiatric disorder
  • Parkinson's disease
  • Disorders of the gastrointestinal and urogenital tracts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Copenhagen NV, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

PhysostigmineSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

PhenylcarbamatesCarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Frank Pott, MD

    Bispebjerg Hospital

    STUDY DIRECTOR

Central Study Contacts

Frank Pott, MD

CONTACT

+4535313531frank.pott@gmail.com

Carsten M Pedersen, MSN

CONTACT

+4535313983carstenmp@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 24, 2009

First Posted

February 25, 2009

Study Start

December 1, 2009

Primary Completion

March 1, 2011

Study Completion

May 1, 2011

Last Updated

May 27, 2010

Record last verified: 2010-05

Locations

DK(1)