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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 26 September 2016
Main ID:  NCT02904928
Date of registration: 04/08/2016
Prospective Registration: No
Primary sponsor: Makerere University
Public title: Incidence and Perioperative Factors Associated With Postoperative Delirium iPOD
Scientific title: Incidence and Perioperative Factors Associated With Postoperative Delirium Among Surgical Patients in Mulago National Referral Hospital
Date of first enrolment: August 2015
Target sample size: 437
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02904928
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Uganda
Contacts
Name:     EMMANUEL T AYEBALE, MMED
Address: 
Telephone:
Email:
Affiliation:  MAKERERE UNIVERSITY DEPARTMENT OF ANAESTHESIA
Name:     DICKENS H AKENA, PHD
Address: 
Telephone:
Email:
Affiliation:  MAKERERE UNIVERSITY DEPARTMENT OF PSYCHIATRY
Name:     AGNES WABULE, MMED
Address: 
Telephone:
Email:
Affiliation:  MAKERERE UNIVERSITY DEPARTMENT OF ANAESTHESIA
Name:     JOSHUA SEMPIIRA, MBCHB
Address: 
Telephone:
Email:
Affiliation:  MAKERERE UNIVERSITY DEPARTMENT OF ANAETHESIA
Key inclusion & exclusion criteria

Inclusion Criteria:

- All adult patients above 18 years who have consented to participate in the study and
are fully conscious by the Glasgow coma scale

Exclusion Criteria:

- Patients with psychiatric disease confirmed by medical documents, as these were
unable to provide informed consent

- Patients undergoing neuro surgery and open heart surgery, as these patients were
expected to remain intubated postoperatively, precluding cognitive assessments.

- Patients scheduled for emergency surgery. Sample size Estimation



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Postoperative Delirium
Intervention(s)
Primary Outcome(s)
incidence of postoperative delirium [Time Frame: 72 hours]
Secondary Outcome(s)
perioperative factors associated with postoperative delirium [Time Frame: up to 72 hours]
Secondary ID(s)
2013/HDO7/611
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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