Effect of Dexmedetomidine on Oxygenation and Lung Mechanics

April 2, 2024 updated by: Amr Samir Wahdan, Cairo University

Effect of Different Does of Dexmedetomidine on Oxygenation and Lung Mechanics

Dexmedetomidine is a selective α -2 agonist widely used in anesthesia for its sympatholytic, sedative and analgesic effects . Favorable respiratory effects in animals , and in selected human patient groups have been reported when using this agent .we investigated the effects of different doses of dexmedetomidine infusion on oxygenation

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

176

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 Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Cairo University

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Morbidly obese patients with restrictive lung disease ASA I AND II laparoscopic sleeve gastrectomy

Exclusion Criteria:

history of heart failure history of cardiac arrhythmias severe liver or kidney impairment. Patients with forced expiratory volume in 1 sec (FEV1)/ FVC < 70%

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group A
Dexmedetomidine (Precedex) loadings of 1 μg/kg than continuously at a rate of 0.2 μg/(kg/h) till the end of the operation .
Drug: GROUP Dexmedetomidine
Dexmedetomidine (Precedex) loadings of 1 μg/kg , then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation .
Active Comparator: group B
Dexmedetomidine (Precedex) loadings of 0.5 μg/kg then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation .
Drug: GROUP B
Dexmedetomidine (Precedex) loadings of 0.5 μg/kg , then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation .
Active Comparator: group C
Dexmedetomidine (Precedex) loadings of 0.25 μg/kg(group C) then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation .
Drug: GROUP C
Dexmedetomidine (Precedex) loadings of 0.25 μg/kg, then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation by the end study
Time Frame: UP TO 6 HOURE
PaO2/Fraction of inspired oxygen
UP TO 6 HOURE

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative dynamic lung compliance
Time Frame: up to 6 hours
tidal volume/ (peak airway pressure -PEEP)
up to 6 hours
Intraoperative static lung compliance
Time Frame: UP TO 6 HOURE
Tidal volume/ (plateau pressure - PEEP)
UP TO 6 HOURE
Physiological dead space
Time Frame: UP TO 6HOURE
1.14 (PaCO2-EtCO2)/ PaCO2-0.005
UP TO 6HOURE

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Amr s wahdan, MD, Cairo university , Cairo, 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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-853

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

still working

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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