Ketamine Versus Dexmedetomidine for Prevention of Postoperative Delirium

NCT ID: NCT05341154

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-05-06

Brief Summary

Delirium is a common postoperative complication in the elderly, often caused by multiple factors. It is defined as an acute neuropsychiatric disorder characterized by fluctuating disturbances in attention, awareness, and cognition. Postoperative delirium occurs in 17-61% of the major surgical procedures. It may be associated with cognitive decline, decreased functional independence, increased risk of dementia, caregiver burden, health care costs, morbidity, and mortality. Therefore, delirium is a possibly disastrous condition and is both a huge burden on a patient's health and on the health care system in general.

Detailed Description

Over the last few decades, numerous risk factors for delirium have been identified, emphasizing the importance of delirium prevention in patients undergoing surgery. It has already been identified as a state that may be associated with serious complications such as prolonged ICU and hospital stays, decreased quality of life, and increased mortality ). Previous studies on delirium pointed out old age and other factors as important predisposing factors. on the health care system in general. Extensive research on reducing the incidence of delirium has been conducted using both pharmacological and non-pharmacological preventive measures in the acute setting. As evidence recommending or opposing specific drugs for the prevention of postoperative delirium remains insufficient and the international guidelines can only recommend perioperative pharmacologic adjustments ("American Geriatrics Society Abstracted Clinical Practice Guideline for Postoperative Delirium in Older Adults," 2015) . Consequently, the challenge of developing reliable hospital algorithms for delirium prevention and treatment remains unresolved. Furthermore, there is a link between postoperative delirium and two biomarkers, cortisol and C- Reactive Protein (CRP), which have previously been linked to delirium but whose significance is unknown.

Conditions

Emergence Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Ketamine group

An anesthesiologist who is not involved in the study will prepare the intervention, ketamine1 mg/kg BW, in a standardized syringe with the same volume. Patients will be given the active comparator or placebo only once right before the induction of anesthesia.

All patients will be received standardized GA protocol as follows:

1. Induction with propofol (1-2 mg/kg body weight).

2. Esmeron (1 mg/kg body weight).

3. Isoflurane is a volatile anesthetic agent in 50% O2 and air.

4. Fentanyl (1 microgram/kg body weight) during induction of anesthesia and the total doses of fentanyl used during the operation will be recorded.

5. All patients received a combination of intravenous paracetamol 1 g and ketorolac 30 mg at the conclusion of surgery. This regimen will be repeated regularly every 8 h.

Group Type: ACTIVE_COMPARATOR

Ketamine Hcl 50Mg/Ml Inj

Intervention Type: DRUG

Patients will be given the active comparator or placebo only once right before the induction of anesthesia.

Dexmedetomidine group

An anesthesiologist who is not involved in the study will prepare the intervention, Dexmedetomidine 1 μg/kg BW, in a standardized syringe with the same volume. Patients will be given the active comparator or placebo only once right before the induction of anesthesia.

All patients will be received standardized GA protocol as follows:

1. Induction with propofol (1-2 mg/kg body weight).

2. Esmeron (1 mg/kg body weight).

3. Isoflurane is a volatile anesthetic agent in 50% O2 and air.

4. Fentanyl (1 microgram/kg body weight) during induction of anesthesia and the total doses of fentanyl used during the operation will be recorded.

5. All patients received a combination of intravenous paracetamol 1 g and ketorolac 30 mg at the conclusion of surgery. This regimen will be repeated regularly every 8 h.

Group Type: ACTIVE_COMPARATOR

Ketamine Hcl 50Mg/Ml Inj

Intervention Type: DRUG

Patients will be given the active comparator or placebo only once right before the induction of anesthesia.

Placebo group

An anesthesiologist who is not involved in the study will prepare the intervention, normal saline 0.9% in a standardized syringe with the same volume. Patients will be given the active comparator or placebo only once right before the induction of anesthesia.

All patients will be received standardized GA protocol as follows:

1. Induction with propofol (1-2 mg/kg body weight).

2. Esmeron (1 mg/kg body weight).

3. Isoflurane is a volatile anesthetic agent in 50% O2 and air.

4. Fentanyl (1 microgram/kg body weight) during induction of anesthesia and the total doses of fentanyl used during the operation will be recorded.

5. All patients received a combination of intravenous paracetamol 1 g and ketorolac 30 mg at the conclusion of surgery. This regimen will be repeated regularly every 8 h.

Group Type: PLACEBO_COMPARATOR

Ketamine Hcl 50Mg/Ml Inj

Intervention Type: DRUG

Patients will be given the active comparator or placebo only once right before the induction of anesthesia.

Interventions

Ketamine Hcl 50Mg/Ml Inj

Patients will be given the active comparator or placebo only once right before the induction of anesthesia.

Intervention Type: DRUG

Other Intervention Names

Dexmedetomidine 1000 mcg/ml inj

Eligibility Criteria

Inclusion Criteria

• 1- Patients aged ≥ 65 years. 2- Scheduled for visceral, orthopedic, vascular, obstetric, urology, or plastic surgery.

Exclusion Criteria

• 1- Delirium upon hospital admission or development of delirium prior to surgery stated by family members.

2- Mini-Mental State Examination (MMSE) score < 24 points 3- Delirium Observation Scale (DOS) ≥4 points 4- preoperative neurological diseases affecting cognitive function (such as vascular dementia) 5- High risk for postoperative treatment in the intensive care unit (ICU) 6- Known to have dexmedetomidine and or ketamine intolerance. 7- Lack of cooperation or communication. 8- Parkinson's disease, parkinsonism, intake of dopaminergic drugs (levodopa, dopamine agonists) 9- Epilepsy. 10- Patients on steroid therapy 11- severe liver and renal insufficiency

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huda Fahmy Mahmoud, PhD

OTHER

Sponsor Role: lead

Responsible Party

Huda Fahmy Mahmoud, PhD

Assistant professor of Anesthesia and Intensive Care

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tarek Sayed, lecturer

Role: PRINCIPAL_INVESTIGATOR

Aswan University

Locations

Huda Fahmy Mahmoud

Aswān, , Egypt

Countries

Egypt

References

Ghazaly HF, Hemaida TS, Zaher ZZ, Elkhodary OM, Hammad SS. A pre-anesthetic bolus of ketamine versus dexmedetomidine for prevention of postoperative delirium in elderly patients undergoing emergency surgery: a randomized, double-blinded, placebo-controlled study. BMC Anesthesiol. 2023 Dec 11;23(1):407. doi: 10.1186/s12871-023-02367-8.

Reference Type: DERIVED

PMID: 38082227 (View on PubMed)

Other Identifiers

548 / 7 / 2021

Identifier Type: -

Identifier Source: org_study_id