Back to results

Effects of Dexmedetomidine on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Operations

Primary Purpose

Restrictive Lung Disease

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Dexmedetomidine

Normal saline

About this trial

This is an interventional treatment trial for Restrictive Lung Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Morbid obese (body mass index > 40) with documented restrictive lung disease scheduled to bariatric operation.

Exclusion Criteria:

Heart failure
ِِِِArrhythmia
Heart block
Severe liver or kidney impairment.

Sites / Locations

Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine group

Control group

Arm Description

Patients will receive either, Dexmedetomidine (Precedex, Hospira, Lake forest, IL, USA) in a dose of (1ug/Kg LBW) bolus followed by 0.5ug/Kg continuous infusion for one hour

Patients will receive normal saline

Outcomes

Primary Outcome Measures

Oxygenation

assessed by P/F ratio

Secondary Outcome Measures

Lung mechanics

lung compliance and dead space

arterial blood pressure

arterial blood pressure measured in mmHg

plateau airway pressure

plateau airway pressure measured in cmH2o

heart rate

number of heart beats per minute

Full Information

NCT ID

NCT02843698

First Posted

July 20, 2016

Last Updated

August 25, 2017

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT02843698

Brief Title

Effects of Dexmedetomidine on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Operations

Official Title

Effects of Dexmedetomidine on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Operations: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

September 2016 (Actual)

Primary Completion Date

August 26, 2017 (Actual)

Study Completion Date

August 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study aims to investigate the effect of dexmedetomidine on oxygenation and lung mechanics in morbidly obese patients

Detailed Description

The patients of interest are morbid obese patients scheduled for bariatric surgery. Dexmeditomidine will be infused intraoperatively after induction of anesthesia. lung mechanics (dead space and compliance) as well as oxygenation (PF ratio) will be monitored intraoperatively and postoperatively

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Restrictive Lung Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexmedetomidine group

Arm Type

Experimental

Arm Description

Patients will receive either, Dexmedetomidine (Precedex, Hospira, Lake forest, IL, USA) in a dose of (1ug/Kg LBW) bolus followed by 0.5ug/Kg continuous infusion for one hour

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Patients will receive normal saline

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Other Intervention Name(s)

Precedex

Intervention Description

Dexmedetomidine infusion was previously reported to improve oxygenation and lung dynamics in patients with obstructive lung diseases. In our study we are going to investigate its effect on oxygenation and lung dynamics in restrictive lung disease

Intervention Type

Drug

Intervention Name(s)

Normal saline

Other Intervention Name(s)

Saline

Intervention Description

Normal saline

Primary Outcome Measure Information:

Title

Oxygenation

Description

assessed by P/F ratio

Time Frame

2 hours

Secondary Outcome Measure Information:

Title

Lung mechanics

Description

lung compliance and dead space

Time Frame

2 hours

Title

arterial blood pressure

Description

arterial blood pressure measured in mmHg

Time Frame

2 hours

Title

plateau airway pressure

Description

plateau airway pressure measured in cmH2o

Time Frame

2 hours

Title

heart rate

Description

number of heart beats per minute

Time Frame

2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Morbid obese (body mass index > 40) with documented restrictive lung disease scheduled to bariatric operation. Exclusion Criteria: Heart failure ِِِِArrhythmia Heart block Severe liver or kidney impairment.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Mukhtar, Professor

Organizational Affiliation

Head of research committee section in anesthesia department

Official's Role

Study Director

Facility Information:

Facility Name

Cairo University

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30103679

Citation

Hasanin A, Taha K, Abdelhamid B, Abougabal A, Elsayad M, Refaie A, Amin S, Wahba S, Omar H, Kamel MM, Abdelwahab Y, Amin SM. Evaluation of the effects of dexmedetomidine infusion on oxygenation and lung mechanics in morbidly obese patients with restrictive lung disease. BMC Anesthesiol. 2018 Aug 14;18(1):104. doi: 10.1186/s12871-018-0572-y.

Results Reference

derived

Learn more about this trial

Effects of Dexmedetomidine on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Operations

We'll reach out to this number within 24 hrs