NCT06355960

Brief Summary

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

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
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

March 28, 2024

Last Update Submit

April 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Oxygenation by the end study

    PaO2/Fraction of inspired oxygen

    UP TO 6 HOURE

Secondary Outcomes (3)

  • Intraoperative dynamic lung compliance

    up to 6 hours

  • Intraoperative static lung compliance

    UP TO 6 HOURE

  • Physiological dead space

    UP TO 6HOURE

Study Arms (3)

group A

ACTIVE COMPARATOR

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

group B

ACTIVE COMPARATOR

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

group C

ACTIVE COMPARATOR

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

Interventions

Dexmedetomidine (Precedex) loadings of 1 μg/kg , then continuously at a rate of 0.2 μg/(kg/h) till the end of the operation .

group A

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 .

group B

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 .

group C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, 11562, Egypt

Location

Study Officials

  • Amr s wahdan, MD

    Cairo university , Cairo, Egypt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 28, 2024

First Posted

April 10, 2024

Study Start

April 1, 2024

Primary Completion

April 1, 2025

Study Completion

May 1, 2025

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations