NCT07443085

Brief Summary

This study evaluates the dose-response relationship of Dexmedetomidine (DEX) in reducing the incidence and severity of postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) in elderly patients. The study compares different doses of DEX against a fentanyl control group in patients undergoing major lower limb orthopedic surgery under general anesthesia to determine the optimal dosage for cognitive protection.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
15mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Feb 2026Oct 2027

First Submitted

Initial submission to the registry

February 25, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

February 26, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

February 25, 2026

Last Update Submit

February 27, 2026

Conditions

Delirium - Postoperative

Outcome Measures

Primary Outcomes (1)

  • Incidence of Postoperative Delirium (POD)

    The percentage of participants diagnosed with delirium within the first 48 hours after surgery. Diagnosis is defined by the Confusion Assessment Method (CAM) algorithm, requiring the presence of acute onset/fluctuating course and inattention, plus either disorganized thinking or altered level of consciousness. Unit of Measure: Percentage of participants

    48 hours post-surgery

Secondary Outcomes (2)

  • Severity of Postoperative Cognitive Dysfunction (POCD)

    1st and 4th weeks post-surgery

  • Postoperative Sedation Level

    24 hours post-surgery

Study Arms (3)

DEX Group 1 (Low Dose)

ACTIVE COMPARATOR

Patients receive a specific low-dose intravenous infusion of Dexmedetomidine during major lower limb orthopedic surgery under opioid-based general anesthesia. The intervention aims to evaluate the dose-response relationship regarding its neuroprotective effects on postoperative delirium (POD).

Drug: Dexmedetomidine (Low dose)

DEX Group 1 (High Dose)

ACTIVE COMPARATOR

Patients receive a higher-dose intravenous infusion of Dexmedetomidine during the surgical procedure. This arm is designed to determine if higher concentrations of DEX provide a more significant reduction in the incidence and severity of postoperative delirium and cognitive dysfunction compared to the lower dose.

Drug: Dexmedetomidine (High dose)

Control Group

ACTIVE COMPARATOR

Patients in this group receive standard opioid-based general anesthesia using fentanyl without the addition of Dexmedetomidine. This group serves as the baseline to compare the efficacy of DEX in preventing cognitive decline.

Drug: Fentanyl

Interventions

Dexmedetomidine (Low dose)DRUG

Patients receive a specific low-dose intravenous infusion of Dexmedetomidine during major lower limb orthopedic surgery under opioid-based general anesthesia. The intervention aims to evaluate the dose-response relationship regarding its neuroprotective effects on postoperative delirium (POD).

DEX Group 1 (Low Dose)
Dexmedetomidine (High dose)DRUG

Patients receive a higher-dose intravenous infusion of Dexmedetomidine during the surgical procedure. This arm is designed to determine if higher concentrations of DEX provide a more significant reduction in the incidence and severity of postoperative delirium and cognitive dysfunction compared to the lower dose.

DEX Group 1 (High Dose)
FentanylDRUG

Patients in this group receive standard opioid-based general anesthesia using fentanyl without the addition of Dexmedetomidine. This group serves as the baseline to compare the efficacy of DEX in preventing cognitive decline.

Control Group

Eligibility Criteria

Age55 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elderly surgical patients.
  • ASA physical status grade II-III.
  • Planned major lower limb orthopedic surgery.

You may not qualify if:

  • pre-existing dementia or drug allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha university

Banhā, Al Qalyobia, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

DexmedetomidineFentanyl

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidines

Central Study Contacts

Islam Shaboub, MD

CONTACT

01062702236basmasalem758@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthiology and Surgical ICU

Study Record Dates

First Submitted

February 25, 2026

First Posted

March 2, 2026

Study Start

February 26, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

March 2, 2026

Record last verified: 2026-02

Locations

EG(1)