Comparison Between the Effect of Dexmedetomidine _midazolam and ketamine_midazolam Combination

NCT07074262 | Completed DMC

• 1 other identifier: Hanaa Fathy Mohamed
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative cognitive dysfunction (POCD) is one of the most common complications after anesthesia, with a prevalence of approximately 12% and a higher prevalence of up to 41.4% in older surgical patients during the entire hospitalization period .A variety of pharmacological therapies are utilized to prevent or minimize POCD. Post-operative delirium is also one of the most common complications following anaesthesia with frequency estimates ranging from 10 to 50%. It is defined as delirium occurring 24 to 72 hours after surgery. There are multiple risk factors for developing postoperative delirium including pre-existing dementia, old age, medical co-morbidities, and psycopathological symptoms. The recognition and treatment of Post-operative delirium is critically important because postoperative delirium is associated with poor outcomes including functional decline, dementia, cognitive impairment, increased hospital length of stay , increased mortality ( 11% increasing in the risk of death at 3 months and up to a 17% increased risk of death at 1 year. Previous studies have examined the relationship between patient-related factors, surgical factors and postoperative delirium. Few studies have examined events in the postoperative period that may contribute to the occurrence of postoperative delirium. Two related and possibly modifiable factors in the postoperative period are postoperative pain and analgesic medications. Although prior studies suggest that postoperative pain and analgesia are associated with postoperative delirium.

Conditions

Postoperative Cognitive Dysfunction; Post Operative Delirium

Outcome Measures

Primary Outcomes (1)

• Postoperative Cognitive Dysfunction and Delirium

  Assessment of the patients whom subjected surgery by using Memorial delirium assessment scale (MDAS) as follows: 1, awareness; 2, orientation; 3, short-term memory; 4, digit span; 5, attention capacity; 6, organizational thinking; 7, perceptual disturbance; 8, delusions; 9, psychomotor activity; and 10, sleep-wake cycle

  First 24 hours and 48 hours after surgery

Study Arms (3)

Control Group

ACTIVE COMPARATOR

About 38 participants received conventional general anesthesia only. Smooth Induction of anesthesia will be done by injecting fentanyl 3-5 μg/kg IV - Midazolam 0.05 to 0.15 mg/kg(Dormicum 1mg/1m ampoul AMOUN com) to be titrated (and atracurium 0.5 mg/kg for muscle relaxation. Laryngoscopy and endotracheal intubation will be performed using oral cuffed tube lubricated with lidocaine gel 2 %. Maintenance of anesthesia will be done using sevoflurane 1.5-2 %, and Mixture of O2 and Air (70%:30%).

Drug: Ketamine

Ketamine group

ACTIVE COMPARATOR

About 38 participants received conventional general anesthesia with administration of Ketamine before induction as follow: Ketamine 1 mg /kg(ketalar Vial 50mg/ml pfzer com) will be administered IV before induction, then a smooth Induction of anesthesia will be done by injecting fentanyl 3-5 μg/kg(23) Midazolam 0.05 to 0.15 mg/kg to be titrated (24) and atracurium 0.5 mg/kg for muscle relaxation. Laryngoscopy and endotracheal intubation will be performed using oral cuffed tube lubricated with lidocaine gel 2 %. Maintenance of anesthesia will be done using sevoflurane 1.5-2% and mixture of O2 and Air (70%: 30%).

Drug: Ketamine

Dexmedetomidine group

ACTIVE COMPARATOR

About 38 participants received conventional general anesthesia with administration of dexmedetomidine before induction as follow:Dexmedetomidine(precedex 100mc/ml 1 mcg Pfizer com) will be injected IV before Induction of anesthesia. Then Induction of anesthesia will be done by injecting fentanyl 3-5 μg/kg(23), Midazolam 0.05 to 0.15 mg/kg to be titrated (24) and atracurium 0.5 mg/kg for muscle relaxation. Laryngoscopy and endotracheal intubation will be performed using oral cuffed tube lubricated with lidocaine gel 2 %. Maintenance of anesthesia will be done using sevoflurane 1.5-2% and mixture of O2 and Air (70%: 30%).

Drug: Ketamine

Interventions

Ketamine DRUG

to compare the effect of Ketamine versus Dexmedetomidine on postoperative cognitive dysfunction and delirium in all cardiac patient undergoing low risk non-cardic surgery.

Also known as: Dexmedetomidine

Control Group; Dexmedetomidine group; Ketamine group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA (II - III) patients above 40 years old.
• Patients diagnosed with a cardiac condition (coronary artery disease, Valvular heart disease , arrhythmias, hypertension ) with EF \> 40% and Moderate to good functional capacity (METS \> 4).
• Patients scheduled to undergo low risk non-cardiac surgical procedures

You may not qualify if:

• Patients having gross hemodynamic or ventilatory fluctuations during the operation.
• Patients with recent myocardial infarction
• Patients who develop postoperative shock, major bleeding or complications.
• Patients with a history of psychiatric disorders.
• Patients with a current history of illicit drug use.
• Patients using hypnotic, anxiolytic, or antipsychotic drugs.
• Allergy to any of the drugs that were used in the study.
• Emergency surgery of Moderate to high risk surgery.
• Pregnancy.
• Patient refusal to give consent

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni- Suef University Hospital

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications; Emergence Delirium

Interventions

Ketamine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mahmoud Attia Nassef, Professor

  Anaesthesiology,Surgical intensive care and pain management,Faculty of Medicine,Beni-Suef University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist of Anesthesia, intensive care and pain management,Faculty of Medicine

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 20, 2025
• Study Start: October 10, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 10, 2025
• Last Updated: July 20, 2025

Record last verified: 2024-10

Locations

EG (1)