NCT06808295

Brief Summary

Assessing the intra and postoperative hemodynamic stability in patients undergoing external dacrocystorhinostomy under general anesthesia using Dexmedetomidine as a preoperative sedation compared to traditional technique with intraoperative analgesia and assessing decreased anesthetic requirements intra and postoperative

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

February 5, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

December 14, 2024

Last Update Submit

January 31, 2025

Conditions

Patients Undergoing External Dacrocystorhinostomy OperationsAssess Decreased Anesthetic Requirements Intraoperative

Outcome Measures

Primary Outcomes (1)

  • Maintained hemodynamic values while reducing the anesthetic requirements

    Measuring the heart rate and the blod pressure every 5 minutes intraoperative and for half an hour postoperative to assess hemodynamic stability

    from 20 minutes after administering the drug till 2 hours after full recovery

Secondary Outcomes (1)

  • Delerium

    from 20 minutes after administering the drug till 2 hours after full recovery

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine 0.25 microgram per kilogram is used in Dacrocystorhinostomy patients 20 minutes before induction of general anesthesia

Drug: Dexmedetomidine Hydrochloride

Control

NO INTERVENTION

Fentanyl as an analgesic is used with general anesthesia in Dacrocystorhinostomy patients

Interventions

Dexmedetomidine HydrochlorideDRUG

drug will be given before induction and anesthetic doses and hemodynamics will be assessed pre- intra and postoperative

Dexmedetomidine

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients of both sexes 16 years to 75 years of age ASA (American society of Anesthesiologists) I-III

You may not qualify if:

  • Pediatric age group
  • ASA more than III

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute of Ophthalmolgy

Giza, Egypt

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Dina Moustafa Mohamed Ali, MD

CONTACT

01113981021dina.moustafa.ali@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 2 Groups, Dexmedetomidine group and control group are assigned
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 14, 2024

First Posted

February 5, 2025

Study Start

April 16, 2024

Primary Completion

April 20, 2025

Study Completion

May 1, 2025

Last Updated

February 5, 2025

Record last verified: 2025-01

Locations

EG(1)