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

NCT03967496 | Completed DMC

• 1 other identifier: MREC #1829
• Study Type: observational
• Target: 402
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Delirium; Anesthesia; Adverse Effect

Keywords

delirium; postoperative complications; anesthesia recovery period

Outcome Measures

Primary Outcomes (3)

• Onset of Immediate postoperative delirium (IPD) in adult patients

  Incidence of Immediate postoperative Delirium during Post-Anesthesia-Care-Unit (PACU) stay (at either 15 minutes or 30 minutes after end of anesthesia) as well as at the time of discharge from PACU

  During PACU stay up to 2 hours.

• Implication of Type of Anesthesia on incidence of Immediate Postoperative Delirium

  Includes General Anesthesia (Inhalational as well as Total intravenous anesthesia), Regional Anesthesia and Monitored anesthesia care

  Intraoperative period

• Effect of Perioperative risk factors on incidence of Immediate Postoperative Delirium

  Perioperative risk factors include: Electrolyte imbalance, anemia, co-morbidities like diabetes, hypertension, ischemic heart disease, chronic kidney diseases etc, preoperative medications like antihypertensives, oral hypoglycemics, insulin, antiplatelets, etc. All details of perioperative management were recorded.

  Perioperative period prior to delirium assessment.

Secondary Outcomes (4)

• Postoperative Length of stay

  Postoperative period up to 8 weeks

• Postoperative Complications

  Postoperative period up to 8 weeks

• Mortality rate

  Postoperative episode up to 8 weeks

• Percentage of cases requiring Postoperative Delirium treatment

  Postoperative period up to 8 weeks

Study Arms (3)

No Delirium

No Delirium: CAM-ICU score of less than 3 throughout Post-Anesthesia Care Unit stay

Procedure: Types of Anesthesia; Procedure: Access of Surgery; Other: Comorbidities; Drug: Preoperative Medication; Diagnostic Test: Routine blood test

Initial Delirium

Initial Delirium: CAM-ICU score of 3 or more at 15 minutes following end of anesthesia and/or at 30 minutes following end of anesthesia

Procedure: Types of Anesthesia; Procedure: Access of Surgery; Other: Comorbidities; Drug: Preoperative Medication; Diagnostic Test: Routine blood test

Delirium

Delirium: CAM-ICU score of 3 or more immediately prior to discharge from Post-Anesthesia Care Unit

Procedure: Types of Anesthesia; Procedure: Access of Surgery; Other: Comorbidities; Drug: Preoperative Medication; Diagnostic Test: Routine blood test

Interventions

Types of Anesthesia PROCEDURE

General Anesthesia includes: Inhalational anesthesia and total intravenous anesthesia. Regional blocks includes: Spinal Anesthesia, Epidural Anesthesia, Plexus Block, Peripheral Nerve Block,... etc Monitored Anesthesia Care: No anesthetic administered but care given for hemodynamic and blood sugar control intraoperatively.

Also known as: Regional Anesthesia, Monitored Anesthesia Care, General Anesthesia

Delirium; Initial Delirium; No Delirium

Access of Surgery PROCEDURE

Type of surgical access

Also known as: Endoscopy, Laparoscopy, Open surgery

Delirium; Initial Delirium; No Delirium

Comorbidities OTHER

A patient may have more than one comorbidity

Also known as: Diabetes, Hypertension, Acute Kidney injury, Chronic Kidney Dysfunction, Ischemic Heart Disease, Bronchial Asthma, Dyslipidemia, Sickle Cell Disease, No Comorbidity

Delirium; Initial Delirium; No Delirium

Preoperative Medication DRUG

Preoperative medications

Also known as: Metformin, Lisinopril, Amlodipine, Insulin, Atorvastatin, Hydralazine, Bisoprolol

Delirium; Initial Delirium; No Delirium

Routine blood test DIAGNOSTIC_TEST

Preoperative and Intraoperative Investigations

Also known as: Serum hemoglobin, White cell count, Serum sodium, Serum potassium, Serum urea, Serum creatinine, Serum bicarbonate, Serum albumin, Random blood sugar

Delirium; Initial Delirium; No Delirium

Eligibility Criteria

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

Study Population

All adults undergoing surgery with any type of anesthesia and any type of surgery under ASA grades 1-3, having no prior neurological abnormalities.

You may qualify if:

• Adult patients (more than 18 years old) scheduled for Elective and Emergency surgery under anaesthesia.
• Adult patients with ASA- 1 2 or 3 status (American Society of Anaesthesiologists Risk Stratification),
• Patients getting anesthesia: general, regional and monitored anesthesia care.
• Patients undergoing open/laparoscopic/endoscopic surgery.

You may not qualify if:

• Refusal to consent
• Patients with ASA- 4 and above risk stratification. Critically ill and unstable patients, shifted from ICU setting and for Emergency surgery.
• Patients with neurological conditions like dementia, psychosis, depression, stroke, head injury and any other pre-existing neurological disease which may interfere with the assessment of delirium.
• Extubation in deep plane of anesthesia where patient is not responsive to verbal commands.
• Deaf and dumb patients
• Inability to comprehend patient language.

Sponsors & Collaborators

• Sultan Qaboos University: lead

Study Sites (1)

Sultan Qaboos University Hospital,

Muscat, 123, Oman

Location

Related Publications (4)

• Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.

  PMID: 2240918 BACKGROUND

• Neufeld KJ, Leoutsakos JM, Sieber FE, Wanamaker BL, Gibson Chambers JJ, Rao V, Schretlen DJ, Needham DM. Outcomes of early delirium diagnosis after general anesthesia in the elderly. Anesth Analg. 2013 Aug;117(2):471-8. doi: 10.1213/ANE.0b013e3182973650. Epub 2013 Jun 11.

  PMID: 23757476 BACKGROUND

• Marcantonio ER, Goldman L, Mangione CM, Ludwig LE, Muraca B, Haslauer CM, Donaldson MC, Whittemore AD, Sugarbaker DJ, Poss R, et al. A clinical prediction rule for delirium after elective noncardiac surgery. JAMA. 1994 Jan 12;271(2):134-9.

  PMID: 8264068 BACKGROUND

• Whitlock EL, Vannucci A, Avidan MS. Postoperative delirium. Minerva Anestesiol. 2011 Apr;77(4):448-56.

  PMID: 21483389 BACKGROUND

MeSH Terms

Conditions

Delirium; Postoperative Complications

Interventions

Anesthesia, Conduction; Anesthesia, General; Endoscopy; Laparoscopy; Conversion to Open Surgery; Comorbidity; Hemoglobin, Sickle; Metformin; Lisinopril; Amlodipine; Insulin; Atorvastatin; Hydralazine; Bisoprolol; Leukocyte Count

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Hemoglobins, Abnormal; Hemoglobins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globins; Hemeproteins; Biguanides; Guanidines; Amidines; Organic Chemicals; Dipeptides; Oligopeptides; Peptides; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids; Phthalazines; Pyridazines; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• ALI AL ABADI, MBCHB FRCA

  SULTAN QABOOS UNIVERSITY HOSPITAL

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2019
• First Posted: May 30, 2019
• Study Start: January 1, 2019
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: May 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

OM (1)