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Effect of Two Different Doses of Dexmedetomidine Infusion in Morbidly Obese Patients

Primary Purpose

Anesthesia, Obesity, Morbid, Dexmedetomidine

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine 0.6
Dexmedetomidine 0.3
Saline
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Body Mass Index above 40 kg/m2 with restrictive lung disease((forced vital capacity) <70% in pre-operative pulmonary function tests), of American Society of anesthesiologists (ASA) physical status II and III. Aged 18-50 years. Scheduled for abdominal surgery. Exclusion Criteria: Patients with Forced expiratory volume1/forced vital capacity<7. Uncontrolled cardiac, respiratory, hepatic or renal diseases. Allergy to the study drug

Sites / Locations

  • Tanta University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomidine 0.6 group

Dexmedetomidine 0.3group

Control group

Arm Description

patients will receive a bolus dose of 1µg/kg dexmedetomidine15 minute after endotracheal intubation over 10 minutes followed by continuous infusion of 0.6 mic/kg/hour for one hour.

patients will receive a bolus dose of 1µg/kg dexmedetomidine 15 minute after endotracheal intubation over 10 minutes followed by continuous infusion of 0.3 mic/kg/hour for one hour.

Patients will receive comparable volume of normal saline (0.9%) 15 minute after endotracheal intubation.

Outcomes

Primary Outcome Measures

Intraoperative oxygenation
Intraoperative oxygenation was assessed by P/F ratio (Arterial oxygen tension/fraction of inspired oxygen) at baseline and the end of drug infusion.

Secondary Outcome Measures

Dynamic Lung compliance
Dynamic lung compliance=tidal volume/ (peak airway pressure- Positive end-expiratory pressure).
Post-operative pain
Assessment of post-operative pain by The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme
Dead space (dead space to tidal volume)
Physiological dead space was calculated by Hardman and Aitkenhead equation: (dead space to tidal volume) = 1.14(PaCO2 -EtCO2)/PaCO2- 0.005 dead space (%) = dead space by end of infusion - dead space at the base line / dead space by the end of drug infusion %
Quality of recovery score
The Quality of recovery score scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery
Time to first rescue analgesia
Time to first rescue analgesia as morphine consumption was recorded
Static lung compliance
Static lung compliance =tidal volume /(plateau pressure - Positive end-expiratory pressure).
Lung compliance
compliance = dynamic compliance at the end of the drug infusion - baseline dynamic compliance.
Plateau pressure
Plateau pressure was calculated by increasing end inspiratory pause to 30-40%.

Full Information

First Posted
July 2, 2023
Last Updated
August 30, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT06018948
Brief Title
Effect of Two Different Doses of Dexmedetomidine Infusion in Morbidly Obese Patients
Official Title
The Effect of Two Different Doses of Dexmedetomidine Infusion on Oxygenation, Lung Mechanics, and Quality of Recovery in Morbidly Obese Patients: A Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Compare the effects of two different doses of dexmedetomidine infusion on oxygenation as a primary outcome and on lung mechanics, quality of recovery and perioperative analgesia as secondary outcomes in morbidly obese patients with restrictive lung disease undergoing abdominal surgery.
Detailed Description
Dexmedetomidine is a selective α2 receptor agonist and has sympatholytic, analgesic, anti-inflammatory and sedative properties. Dexmedetomidine decreased dead space and improved both lung compliance and oxygenation in chronic obstructive pulmonary disease (COPD) patients undergoing lung cancer surgery. The effects of dexmedetomidine on oxygenation and lung mechanics had been investigated in obstructive lung disease, but there are little information about its effect in morbidly obese patients with restrictive lung disease .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Obesity, Morbid, Dexmedetomidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine 0.6 group
Arm Type
Active Comparator
Arm Description
patients will receive a bolus dose of 1µg/kg dexmedetomidine15 minute after endotracheal intubation over 10 minutes followed by continuous infusion of 0.6 mic/kg/hour for one hour.
Arm Title
Dexmedetomidine 0.3group
Arm Type
Active Comparator
Arm Description
patients will receive a bolus dose of 1µg/kg dexmedetomidine 15 minute after endotracheal intubation over 10 minutes followed by continuous infusion of 0.3 mic/kg/hour for one hour.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients will receive comparable volume of normal saline (0.9%) 15 minute after endotracheal intubation.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine 0.6
Intervention Description
Patients received a bolus dose of 1μg/kg Dexmedetomidine, 15 minutes after endotracheal intubation over 10 minutes followed by infusion of 0.6 μg/kg/hr for one hour.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine 0.3
Intervention Description
Patients received a bolus dose of 1μg/kg Dexmedetomidine, 15 minutes after endotracheal intubation over 10 minutes followed by infusion of 0.3 μg/kg/hr for one hour.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Patients received over 10 minutes comparable volume of normal saline (0.9%) 15 min after endotracheal intubation followed by infusion.
Primary Outcome Measure Information:
Title
Intraoperative oxygenation
Description
Intraoperative oxygenation was assessed by P/F ratio (Arterial oxygen tension/fraction of inspired oxygen) at baseline and the end of drug infusion.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Dynamic Lung compliance
Description
Dynamic lung compliance=tidal volume/ (peak airway pressure- Positive end-expiratory pressure).
Time Frame
Intraoperative
Title
Post-operative pain
Description
Assessment of post-operative pain by The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme
Time Frame
24 hour postoperatively
Title
Dead space (dead space to tidal volume)
Description
Physiological dead space was calculated by Hardman and Aitkenhead equation: (dead space to tidal volume) = 1.14(PaCO2 -EtCO2)/PaCO2- 0.005 dead space (%) = dead space by end of infusion - dead space at the base line / dead space by the end of drug infusion %
Time Frame
Intraoperative
Title
Quality of recovery score
Description
The Quality of recovery score scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery
Time Frame
24 hours Postoperatively
Title
Time to first rescue analgesia
Description
Time to first rescue analgesia as morphine consumption was recorded
Time Frame
24 hours Postoperatively
Title
Static lung compliance
Description
Static lung compliance =tidal volume /(plateau pressure - Positive end-expiratory pressure).
Time Frame
Intraoperative
Title
Lung compliance
Description
compliance = dynamic compliance at the end of the drug infusion - baseline dynamic compliance.
Time Frame
24 hours
Title
Plateau pressure
Description
Plateau pressure was calculated by increasing end inspiratory pause to 30-40%.
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body Mass Index above 40 kg/m2 with restrictive lung disease((forced vital capacity) <70% in pre-operative pulmonary function tests), of American Society of anesthesiologists (ASA) physical status II and III. Aged 18-50 years. Scheduled for abdominal surgery. Exclusion Criteria: Patients with Forced expiratory volume1/forced vital capacity<7. Uncontrolled cardiac, respiratory, hepatic or renal diseases. Allergy to the study drug
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
El-Gharbia
ZIP/Postal Code
31527
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD Sharing Time Frame
after the end of study for one year.
IPD Sharing Access Criteria
The data will be available upon a reasonable request from the corresponding author

Learn more about this trial

Effect of Two Different Doses of Dexmedetomidine Infusion in Morbidly Obese Patients

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