The Efficacy of Dexmedetomidine Versus Labetalol In Providing Controlled Hypotension In Dacryocystorhinostomy SurgeryA Comparative Randomized Prospective Study

March 28, 2024 updated by: Mohamed Aboesoud Mahmoud, Sohag University

The most important symptoms of nasolacrimal duct obstruction are excessive tearing and mucoid discharge.

The proposed treatment in this regard is dacryocystorhinostomy (DCR) surgery. Therefore, hemostasis is of great significance in performing DCR surgery. In this regard, the reduction of controlled hypotension and the control of hemodynamic responses of the body to stress effectively reduce the bleeding volume during surgery.

Hence, there is no enough studies about controlled hypotension in DCR we decided to perform such a comparison between the effect of dexmedetomidine and labetalol in providing controlled hypotension during DCR surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

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 Contact Backup

  • Name: Elhadad A Mousa, Professor
  • Phone Number: 01019816967

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag university hospitals
        • Contact:
          • Magdy M Amin, professor

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • physical status I or II according to ASA classification, age between ( 18 - 60 years )

Exclusion Criteria:

  • Patients with physical status other than 1 and 2 according to ASA classification as :Hypertension, Diabetes mellitus, Ischemic heart diseases, Severe anemia, COPD, History of stroke, Impaired liver or renal function, Increase intercranial tension.
  • Allergy to any of the drug included in this study.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexmedetomidine group
Drug: Dexmedetomidine
the reduction of controlled hypotension and the control of hemodynamic responses of the body
Drug: Labetalol
the reduction of controlled hypotension and the control of hemodynamic responses of the body
Active Comparator: Labetalol group
Drug: Dexmedetomidine
the reduction of controlled hypotension and the control of hemodynamic responses of the body
Drug: Labetalol
the reduction of controlled hypotension and the control of hemodynamic responses of the body

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess non invasive blood pressure during DCR surgery To compare between the effect of dexmedetomidine and labetalol in providing controlled hypotension.
Time Frame: 5 months

Controlled Hypotension In Dacryocystorhinostomy Surgery By:

Dexmedetomidine is a potent α2 adrenergic agonist. Labetalol is a beta-adrenergic blocker agent with alpha1 and beta-adrenergic receptors blocking action
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of dexamedetomidine for prolongation of postoperative analgesia.
Time Frame: 5 months
Dexmedetomidine is a potent α2 adrenergic agonist. One of the highest densities of α2 receptors is located in the pontine locus cereleus, an important nucleus mediating sympathetic nervous system function. It has sedative, anxiolytic, hypnotic, analgesic, and sympatholytic properties.
5 months

Collaborators and Investigators

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

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

March 30, 2024

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

March 10, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-02-10MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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