NCT03967496: AIPDAP

Assessment of Immediate Postoperative Delirium (IPD) in Adult Patients: Incidence and Etiologic Factors

Completed Last updated 30 May 2019

What this trial tests

trial testing Types of Anesthesia in Delirium in 402 participants. Completed in 31 March 2019.

Timeline

1 January 2019

Primary endpoint
31 March 2019

31 March 2019

Quick facts

Lead sponsor	Sultan Qaboos University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	402
Start date	1 January 2019
Primary completion	31 March 2019
Estimated completion	31 March 2019
Sites	1 location across Oman

Drugs / interventions tested

• Types of Anesthesia
• Access of Surgery
• Comorbidities
• Preoperative Medication — full drug profile →
• Routine blood test

Conditions studied

• Delirium — all drugs for Delirium →
• Anesthesia; Adverse Effect — all drugs for Anesthesia; Adverse Effect →

Sponsor

Sultan Qaboos University

Who can join

18 and older, any sex, with Delirium or Anesthesia; Adverse Effect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Delirium is considered to be acute failure of central nervous system. It is acute confusional state characterized by decline from baseline mental level, attention deficit and disorganized thinking.

Postoperative delirium is known to prolong length of stay in hospital, cause functional decline and dementia, increase all-cause mortality and increase the medical cost. It is also associated with other outcomes like cardiac arrest, ventricular tachycardia or fibrillation, myocardial infarction, pulmonary edema, pulmonary embolism, bacterial pneumonia, respiratory failure requiring intubation, renal failure requiring dialysis and stroke.

There are well known predisposing and precipitating factors related to its etiology. However, the effect of type of anesthesia is not very clear. There have been no major clinical trials in this part of the world to delineate the incidence of immediate postoperative delirium (IPD). The investigators have undertaken this prospective observational study to determine the incidence of IPD and its etiological factors in adult patients during their stay in the Post-Anesthesia Care Unit (PACU) following surgery under different types of anesthesia (general anesthesia, regional anesthesia and monitored anesthesia care). The study was done over a period of about three months.

Assessment for delirium was done using Confusion Assessment Method-Intensive Care Unit (CAM-ICU score, English/Arabic version). Sedation and Agitation were assessed using Richmond Agitation Sedation Score (RASS). Pain was assessed using Numeric Pain Score (NPS). Assessment was done within 24 hours prior to surgery and was repeated at three different intervals in PACU. Details of perioperative management were recorded and analyzed. The incidence of IPD and its etiologic factors were identified thereby leading to corrective action.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Assessment of Immediate Postoperative Delirium in Neurologically Intact Adult Patients Admitted to the Post-anesthesia Care Unit: A Cross-Sectional Study.
   Burad J, Date R, Al Ismaili M, Sharma P, et al · · 2022 · PMID 36277521 · DOI 10.7759/cureus.29312