NCT03892512

Brief Summary

Dexmedetomidine is a highly selective α2adrenoceptor agonist recently introduced to anesthesia that produces dose dependent sedation, anxiolysis, and analgesia (involving spinal and supraspinal sites) without respiratory depression. From a pharmacokinetic perspective,dexmedetomidine has a half life of nearly 2 hours, duration of action of nearly 4 hour, and thus, a side effect profile that is shorter in duration than clonidine. Esmolol is a cardioselective beta₁ receptor blocker with rapid onset, a very short duration of action (elimination half-life is approximately 9 minutes) , and no significant intrinsic sympathomimetic or membrane stabilising activity at therapeutic dosages

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

8 months

First QC Date

March 23, 2019

Last Update Submit

March 26, 2019

Conditions

Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

  • assess the early cognitive dysfunction after controlled hypotensive anesthesia

    mini mental state examination (MMSE) will be used for evaluation of cognitive function Data will be expressed in mean ± SD and were compared using analysis of variance (ANOVA). The significance of non-parametric data was determined using chi-square test. For all comparisons P \< 0.05 was considered significant.,

    MMS will performed at 1 hour, 6 and 24 hours postoperatively .The mximum score will be 30 points, a decrease of 2 or more will be considered as cognitive function decline. score less than 23 will be considered as cognitive impairmen

Study Arms (2)

dexmedetomedine

ACTIVE COMPARATOR

The Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex .Pfizer CO ) .

Drug: Dexmedetomidine

esmolol

ACTIVE COMPARATOR

Patients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride . Baxter CO ).

Drug: Esmolol Hydrochloride

Interventions

Esmolol HydrochlorideDRUG

Patients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride )

Also known as: esmolol
esmolol
DexmedetomidineDRUG

The Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex )

Also known as: precedex
dexmedetomedine

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aging 20-50 years ASA physical status I-II . Males , females

You may not qualify if:

  • hypertensive patient
  • Patients receiving sedatives as midazolam.
  • Patients with ischemic heart diseases, heart block, congestive heart failure, valvular heart diseases.
  • Patients with cerebrovascular diseases.
  • Patients with impaired kidney function.
  • Patients with history of chronic liver diseases.
  • Patients with asthma, chronic obstructive lung diseases.
  • Patients with diabetes mellitus, coagulation disorders, pregnancy.
  • Patients with history of allergy to the drugs used in the study or patients with substance abuse .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni-Suef University Hospital

Banī Suwayf, Egypt

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

esmololDexmedetomidine

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Samaa ak Rashwan, MD

    Assisstant proffesor of anesthesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samaa ak Rashwan, MD

CONTACT

020120159125samakassemrashwan@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Samaa Abou Alkassem Rashwan

Study Record Dates

First Submitted

March 23, 2019

First Posted

March 27, 2019

Study Start

April 1, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 27, 2019

Record last verified: 2019-03

Locations

EG(1)