Dexmedetomidine Effect on Delirium of Elderly Patients

NCT06111300 | Unknown Phase 4 DMC

• 1 other identifier: delirium in elderly patients
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Effect of Dexmedetomidine on the Incidence of Delirium Incidence of Post-operative Delirium in Elderly Patients Undergoing Emergency Laparotomy

Conditions

Delirium in Old Age

Outcome Measures

Primary Outcomes (1)

• Delirium among elderly

  Incidence of delirium among elderly patients undergoing emergency laparotomy.

  3 days

Study Arms (2)

group d

EXPERIMENTAL

Patients in this group will receive loading dose of dexmedetomidine 0.7 ug/kg over 10 min. then maintenance dose 0.2 - 1 ug/kg/hr till end of surgery.

Drug: Dexmedetomidine

group c

PLACEBO COMPARATOR

Patients in this group will receive volume- matched normal saline infusion (NaCL 0.9%) as a placebo.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Group D (dexmedetomidine group): Patients in this group will receive loading dose of dexmedetomidine 0.7 ug/kg over 10 min. then maintenance dose 0.2 - 1 ug/kg/hr till end of surgery. Group C (control group): Patients in this group will receive volum- matched normal saline infusion (NaCL 0.9%) as a placebo.

group c; group d

Eligibility Criteria

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

You may qualify if:

• Patients aged 60 years or older of either gender.
• Patient undergoing emergency laparotomy either trauma or non-trauma patients.

You may not qualify if:

• Patients unable to provide written consent.
• Patients less than 60 years.
• Known drug intolerance or allergy to dexmedetomidine.
• Patients previously diagnosed to suffer from major neurocognitive disorder, defined by a mini-mental state examination (MMSE) score \< 24.
• Severe audiovisual impairment.
• Child C chronic liver disease.
• Traumatic brain injury.
• Intracranial bleeding \< 1y.
• Psychiatric illness.
• History of alcohol or drug abuse.
• Preoperative cerebrovascular accident with residual neurological deficit.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: control group will take placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant lecturer

Model Details: Group D (dexmedetomidine group): Patients in this group will receive loading dose of dexmedetomidine 0.7 ug/kg over 10 min. then maintenance dose 0.2 - 1 ug/kg/hr till end of surgery.Group C (control group): Patients in this group will receive volum- matched normal saline infusion (NaCL 0.9%) as a placebo.

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: November 1, 2023
• Study Start: November 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2025
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share