Dexmedetomidine an Effective Drug in Reducing Anesthetic Requirements in External Dacrocystorhinostomy (DCR) Patients (DCR)

January 31, 2025 updated by: Dina Moustafa Mohamed, Research Institute of Ophthalmology, Egypt

Dexmedetomidine As an Effective Drug in Reducing Anesthetic Requirements in Patients Undergoing External Dacrocystorhinostomy, a Randomized Controlled Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Dexmedetomidine is a highly selective alpha 2 adrenoceptor agonist, having characteristics of natural sleep like sedation, can reduce pain intensity and opioid consumption without influencing the time of recovery from general anesthesia

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Research Institute of Ophthalmolgy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pediatric age group
  • ASA more than III

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexmedetomidine
Dexmedetomidine 0.25 microgram per kilogram is used in Dacrocystorhinostomy patients 20 minutes before induction of general anesthesia
Drug: Dexmedetomidine Hydrochloride
drug will be given before induction and anesthetic doses and hemodynamics will be assessed pre- intra and postoperative
No Intervention: Control
Fentanyl as an analgesic is used with general anesthesia in Dacrocystorhinostomy patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maintained hemodynamic values while reducing the anesthetic requirements
Time Frame: from 20 minutes after administering the drug till 2 hours after full recovery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delerium
Time Frame: from 20 minutes after administering the drug till 2 hours after full recovery
Reducing postoperative delirium in elderly patients
from 20 minutes after administering the drug till 2 hours after full recovery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Institute of Ophthalmology, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2024

Primary Completion (Estimated)

April 20, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

December 14, 2024

First Submitted That Met QC Criteria

January 31, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-11-17-6-5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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