Incidence and Perioperative Factors Associated With Postoperative Delirium

NCT02904928 | Completed DMC

• 1 other identifier: 2013/HDO7/611
• Study Type: observational
• Target: 437
• Locations: 1 country
• Sites: 1

Brief Summary

With the increasing number of advanced surgical operations being done annually, including the elderly, the risk of developing postoperative delirium is potentially high. Postoperative delirium is associated with longer hospital stay, poorer functional outcome, cognitive decline and an elevated morbidity and mortality, in addition to an increased cost of health care. However, most of the studies on postoperative delirium have been done in high income countries, leaving a paucity of literature on the incidence and associated factors of postoperative delirium in Africa and hence a need to do this study.

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• incidence of postoperative delirium

  the CAM assessment tool was administered preoperative and then delirium assessed postoperatively at the times given above using a CAM diagnostic tool administered by research assistant.when the patient was CAM positive at any time they were discontinued from the study

  72 hours

Secondary Outcomes (1)

• perioperative factors associated with postoperative delirium

  up to 72 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients with surgical disease admitted on the surgical wards in Mulago National Referral Hospital scheduled for surgery during the study period who met the eligibility criteria

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Makerere University: lead

Study Sites (1)

Mulago Hospital Complex

Kampala, Kampala, 256, Uganda

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• JOSHUA SEMPIIRA, MBCHB

  MAKERERE UNIVERSITY DEPARTMENT OF ANAETHESIA

  PRINCIPAL INVESTIGATOR

• DICKENS H AKENA, PHD

  MAKERERE UNIVERSITY DEPARTMENT OF PSYCHIATRY

  STUDY DIRECTOR

• EMMANUEL T AYEBALE, MMED

  MAKERERE UNIVERSITY DEPARTMENT OF ANAESTHESIA

  STUDY DIRECTOR

• AGNES WABULE, MMED

  MAKERERE UNIVERSITY DEPARTMENT OF ANAESTHESIA

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: September 19, 2016
• Study Start: August 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: April 1, 2016
• Last Updated: September 19, 2016

Record last verified: 2015-05

Locations

UG (1)