Ketofol for Preventing Postoperative Delirium in Elderly Patients

NCT04816162 | Completed Phase 4

• 1 other identifier: 6704/10-3-2021
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

• Delirium is a cognitive disturbance characterized by acute and fluctuating impairment in attention and awareness. Although its incidence in the general surgical population is 2-3%, it has been reported to occur in up to 10-80% of high-risk patient groups. In addition, the occurrence of postoperative delirium is associated with considerably raised morbidity and mortality and increased healthcare resource expenditure.
• In the general patient population, no prophylactic pharmacologic treatment has shown widespread effectiveness in preventing delirium. Several studies have failed to find a magic pharmacologic bullet for preventing delirium-ketamine, haloperidol, propofol, antipsychotic and benzodiazepine drugs have recently tested without a clear result of its effectiveness.
• Dexmedetomidine is an attractive pharmacologic option because of its biological plausibility in modifying several known contributors to delirium.
• Up to investigators' knowledge, there is no study done to compare the effect of infusion of dexmedetomidine and ketofol mixture as prophylactic agents for high-risk patients as elderly patients who undergoing high-risk surgery such as intestinal obstruction surgery against postoperative delirium occurrence.

Conditions

Delirium on Emergence

Keywords

ketofol; dexmedetomidine; post operative delirium; elderly patients

Outcome Measures

Primary Outcomes (1)

• incidence of post operative delirium

  Patients will be assessed for postoperative delirium using Confusion Assessment Method (CAM), or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)

  up to first three postoperative days

Secondary Outcomes (2)

• changes of pain assessment

  30 minutes, 1 hour, 2, 4, 18, 12, 24 hours postoperatively

• changes of hemodynamics

  immediately prior to surgery, intraoperative (after starting infusion of study drug, then every 10 minute till end of surgery), later on they will be measured every 15 min postoperatively up to two hours postoperatively

Study Arms (3)

Control group

PLACEBO COMPARATOR

21 ml of normal saline 0.9% will be I.V continuously infused fifteen minutes after induction of anesthesia up to two hours postoperatively.

Other: normal saline

ketofol group

ACTIVE COMPARATOR

21 ml of a mixture of (ketamine and propofol) will be I.V continuously infused fifteen minutes after induction of anesthesia up to two hours postoperatively

Drug: ketofol

dexmedetomidine group

ACTIVE COMPARATOR

21 ml of a mixture of (dexmedetomidine diluted with normal saline 0.9%) will be I.V continuously infused fifteen minutes after induction of anesthesia up to two hours postoperatively

Drug: dexmedetomidine

Interventions

ketofol DRUG

prepared in a ratio of (1:4) respectively), where 1ml of ketamine will be added to 20 ml of propofol in a syringe pump

Also known as: a mixture of propofol and ketamine

ketofol group

dexmedetomidine DRUG

2 ml (200 µg) of dexmedetomidine added to 0.9% normal saline in a syringe pump

Also known as: precedex

dexmedetomidine group

normal saline OTHER

normal saline 0.9% in a syringe pump

Control group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient acceptance.
• Age ≥ 60 years old.
• American society of anesthesia (ASA) (II-III).
• Gender: males \&females
• BMI \< 35kg/m2.
• able to communicate verbally.
• Scheduled for exploration surgery for intestinal obstruction under general anesthesia of at least 60 min duration

You may not qualify if:

• Patient refusal.
• Patients with delirium prior to surgery.
• Patients with drug misuse history or taking anti-psychotic drugs.
• Previous hospitalization within 3 months.
• Legal blindness, severe deafness.
• History of Acute cerebrovascular conditions; stroke or transient ischemic attack.
• Patients who could not be prepared with proper fluid resuscitation, electrolyte and acid-base correction prior to surgery.
• Patients who could be discharged from the intensive care unit (ICU) within two days.
• Patients with a known history of allergy to study drugs

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of medicine, zagazig university

Zagazig, Alsharqia, 4115, Egypt

Location

Related Publications (7)

• Spangler R, Van Pham T, Khoujah D, Martinez JP. Abdominal emergencies in the geriatric patient. Int J Emerg Med. 2014 Oct 21;7:43. doi: 10.1186/s12245-014-0043-2. eCollection 2014.

  PMID: 25635203 BACKGROUND

• Ozturk E, van Iersel M, Stommel MM, Schoon Y, Ten Broek RR, van Goor H. Small bowel obstruction in the elderly: a plea for comprehensive acute geriatric care. World J Emerg Surg. 2018 Oct 20;13:48. doi: 10.1186/s13017-018-0208-z. eCollection 2018.

  PMID: 30377439 BACKGROUND

• Dale O, Somogyi AA, Li Y, Sullivan T, Shavit Y. Does intraoperative ketamine attenuate inflammatory reactivity following surgery? A systematic review and meta-analysis. Anesth Analg. 2012 Oct;115(4):934-43. doi: 10.1213/ANE.0b013e3182662e30. Epub 2012 Jul 23.

  PMID: 22826531 BACKGROUND

• Maldonado JR, Wysong A, van der Starre PJ, Block T, Miller C, Reitz BA. Dexmedetomidine and the reduction of postoperative delirium after cardiac surgery. Psychosomatics. 2009 May-Jun;50(3):206-17. doi: 10.1176/appi.psy.50.3.206.

  PMID: 19567759 BACKGROUND

• Li WX, Luo RY, Chen C, Li X, Ao JS, Liu Y, Yin YQ. Effects of propofol, dexmedetomidine, and midazolam on postoperative cognitive dysfunction in elderly patients: a randomized controlled preliminary trial. Chin Med J (Engl). 2019 Feb;132(4):437-445. doi: 10.1097/CM9.0000000000000098.

  PMID: 30707179 BACKGROUND

• Smischney NJ, Hoskote SS, Gallo de Moraes A, Racedo Africano CJ, Carrera PM, Tedja R, Pannu JK, Hassebroek EC, Reddy DR, Hinds RF, Thakur L. Ketamine/propofol admixture (ketofol) at induction in the critically ill against etomidate (KEEP PACE trial): study protocol for a randomized controlled trial. Trials. 2015 Apr 21;16:177. doi: 10.1186/s13063-015-0687-0.

  PMID: 25909406 BACKGROUND

• Abd Ellatif SE, Mowafy SMS, Shahin MA. Ketofol versus Dexmedetomidine for preventing postoperative delirium in elderly patients undergoing intestinal obstruction surgeries: a randomized controlled study. BMC Anesthesiol. 2024 Jan 2;24(1):1. doi: 10.1186/s12871-023-02378-5.

  PMID: 38166598 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

Ketamine; Dexmedetomidine; Saline Solution

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Shereen E Abd Ellatif, MD

  faculty of human medicine,zagazig university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double-blinded(participants and outcome assessors)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: A computer-generated table will be used to divide patients equally into three study groups * In group C (control group):21 ml of normal saline 0.9% will be I.V infused at a rate of 0.3-0.4 mg/kg/h to the patient. * In group K: ketofol (a mixture of ketamine and propofol will be prepared in a ratio of (1:4) respectively), will be I.V infused at a rate of 0.3-0.4 mg/kg/h to the patient. * In group D: adding dexmedetomidine 2 ml (200 µg) to 19 ml of 0.9% normal saline to start I.V infusion to the patient

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 25, 2021
• Study Start: March 25, 2021
• Primary Completion: November 1, 2022
• Study Completion: February 1, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: planned after the completion of the study and publication
• Access Criteria: contact with principal investigator

Locations

EG (1)