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DeliriumAIPDAPNCT03967496

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

An observational study of Delirium and Anesthesia; Adverse Effect, run by Sultan Qaboos University at 1 site in Oman.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Delirium, Anesthesia; Adverse Effect
What is being tested?
Types of Anesthesia, Access of Surgery and Comorbidities
How many people
402 participants
Where
1 siteOman
Study dates
1 Jan 2019to 31 Mar 2019
How long will I take part?
8 Weeks
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Oman1 site
  • Sultan Qaboos University Hospital,

    Muscat, 123

Other trials in Oman

About this study

Official title: Assessment of Immediate Postoperative Delirium (IPD) in Adult Patients: Incidence, Implication of Type of Anesthesia and Identification of Other Etiological Factors

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.

Read more

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.

Read the detailed description

Decision to perform this observational study was made due to the lack of information on the local incidence and risk factors for the development of immediate postoperative delirium (IPD).

A literature review was done to study the already implicated perioperative causative factors as well as other significant perioperative factors.

A consultant neurologist was contacted to confirm the appropriateness of using CAM-ICU, RASS and NPS as assessment tools for the study. Doctors and nurses were trained on the proper use of the assessment tools using educational material at www.icudelirium.org. Permission was obtained from the author who has done validation of arabic version of CAM-ICU score. A proforma was prepared and local Ethical committee approval was obtained.

A pilot study of 24 cases showed the incidence of IPD to be about 25%. The investigators expected to have a total of 600 adult cases undergo anesthesia during the study period of three months. Based on a population size of 600 patients, a level of confidence of 95% and an error of 10% on either side, the optimum sample size was calculated as 395 patients.

The details of the study were explained to each patient with help of information sheet by a dedicated nurse and a doctor well versed in local language. After patient agreement, a written informed consent was obtained. The preoperative scoring of pain, anxiety and agitation and delirium was done by a dedicated nurse under supervision of a doctor who was not involved in providing anesthesia to the patient. Pain was assessed using NPS, sedation/agitation/anxiety using RASS and delirium using CAM-ICU score.

Patient identity was concealed and names were not written in the master chart. The data were entered and identified by the hospital medical registration number (MRN) as well as code number. The patient data were kept locked with password protected file by principal investigators. The premedication choice, anesthetic technique and intraoperative management were carried out in the usual way and recorded on proforma.

Further patient specific data were obtained using the Hospital Information System and Operating Room record. The following data were recorded for each patient:

Demographic Data: Age, gender of the patient

Comorbidity Data: All co-morbidities of patient like diabetes, hypertension, bronchial asthma, ischemic heart disease, jaundice, carcinoma, liver disease, kidney disease, drug addiction, alcoholism, sickle cell disease, medication details and any other co-morbidities.

Laboratory Data: hemoglobin level, creatinine, electrolyte levels, serum albumin, ammonia level and any blood work done preoperative, intraoperative or postoperative in PACU.

Surgical Data: diagnosis, urgency and name of surgery

Peri-operative Anesthetic Data: American Society of Anesthesiologists (ASA) class, premedication, pre-operative medications, hydration status, anesthetic method, analgesics, prophylactic anti-emetic drugs, intraoperative hemodynamic parameters, oxygen saturation, ventilation status, acid-base status, presence of sepsis, fluid and electrolyte imbalance, pain, myocardial infarction, hypo/hyperthermia, alcohol withdrawal and other significant conditions.

Presence of an airway, urinary catheter or a surgical drain at admission to PACU was also recorded.

At the end of anesthesia, all patients were transferred to PACU. The management of the patient was done in the usual manner as prescribed by the involved anesthetist and carried out by allocated PACU nurse. Patients were assessed for pain, agitation, sedation and delirium using NPS, RASS and CAM-ICU score by another trained staff nurse who was not involved in patient management. Scoring was done at fifteen minutes from end of anesthetic, thirty minutes from end of anesthetics and just prior to discharge from PACU (up to 120 minutes from end of anesthetic).

Postoperative course (presence of delirium, requirement of treatment for delirium, length of stay, postoperative complications, admission to high dependency unit or Intensive care unit) was followed via electronic patient record and recorded by concerned anesthetist on the proforma.

The proforma were handed over to the principal investigator and were kept locked. The recorded patient data except the name were entered by one of the assigned co-investigator into the master chart. A copy of master chart without MRN was sent to statistician for analysis.

Being tested
Types of Anesthesia, Access of Surgery, Comorbidities, Preoperative Medication, Routine blood test
Keywords
delirium, postoperative complications, anesthesia recovery period
Medical subject headings
Delirium, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Types of AnesthesiaProcedure or surgery

    Also called Regional Anesthesia, Monitored Anesthesia Care, General Anesthesia

    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.

  • Access of SurgeryProcedure or surgery

    Also called Endoscopy, Laparoscopy, Open surgery

    Type of surgical access

  • ComorbiditiesOther

    Also called Diabetes, Hypertension, Acute Kidney injury, Chronic Kidney Dysfunction

    A patient may have more than one comorbidity

  • Preoperative MedicationDrug

    Also called Metformin, Lisinopril, Amlodipine, Insulin

    Preoperative medications

  • Routine blood testDiagnostic test

    Also called Serum hemoglobin, White cell count, Serum sodium, Serum potassium

    Preoperative and Intraoperative Investigations

Study groups in NCT03967496
Study groupRoleWhat they receive
No DeliriumNo Delirium: CAM-ICU score of less than 3 throughout Post-Anesthesia Care Unit stay
Receives: Procedure: Types of Anesthesia; Procedure: Access of Surgery; Other: Comorbidities; Drug: Preoperative Medication; Diagnostic Test: Routine blood test
Initial DeliriumInitial Delirium: CAM-ICU score of 3 or more at 15 minutes following end of anesthesia and/or at 30 minutes following end of anesthesia
Receives: Procedure: Types of Anesthesia; Procedure: Access of Surgery; Other: Comorbidities; Drug: Preoperative Medication; Diagnostic Test: Routine blood test
DeliriumDelirium: CAM-ICU score of 3 or more immediately prior to discharge from Post-Anesthesia Care Unit
Receives: Procedure: Types of Anesthesia; Procedure: Access of Surgery; Other: Comorbidities; Drug: Preoperative Medication; Diagnostic Test: Routine blood test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: During PACU stay up to 2 hours.

  2. 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

    Measured: Intraoperative period

  3. 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.

    Measured: Perioperative period prior to delirium assessment.

Secondary outcomes (4)
  1. Postoperative Length of stay

    From Day of Surgery till Discharge

    Measured: Postoperative period up to 8 weeks

  2. Postoperative Complications

    urinary infection, Pneumonia, wound infection, Multi-organ failure or any other complications during that surgical episode.

    Measured: Postoperative period up to 8 weeks

  3. Mortality rate

    Mortality due to All causes during the specific postoperative episode up to 8 weeks

    Measured: Postoperative episode up to 8 weeks

  4. Percentage of cases requiring Postoperative Delirium treatment

    Pharmacological as well as Non-pharmacological treatment administered during the postoperative stay in the specific surgical episode up to 8 weeks.

    Measured: Postoperative period up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2019
  2. Study start1 Jan 2019
  3. Primary completion31 Mar 2019
  4. Study completion31 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
402 participants (actual)
Target duration
8 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT03967496
Sponsor's protocol ID
MREC #1829
Acronym
AIPDAP
Status last verified
May 2019
First submitted
19 May 2019
Last updated
30 May 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: As per the Institutional norms we are not supposed to share the data with regards to the study with others.

Publications

  • 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.

    PubMed 2240918
  • 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.

    PubMed 23757476
  • 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.

    PubMed 8264068
  • Whitlock EL, Vannucci A, Avidan MS. Postoperative delirium. Minerva Anestesiol. 2011 Apr;77(4):448-56.

    PubMed 21483389

Questions about this trial

What is this clinical trial studying?

An observational study of Delirium and Anesthesia; Adverse Effect, run by Sultan Qaboos University at 1 site in Oman.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Oman. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Onset of Immediate postoperative delirium (IPD) in adult patients (time frame: During PACU stay up to 2 hours.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03967496, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.

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