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

NCT ID: NCT06018948

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-09-30

Brief Summary

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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

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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 .

Conditions

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Anesthesia Obesity, Morbid Dexmedetomidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dexmedetomidine 0.6 group

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.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine 0.6

Intervention Type DRUG

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.

Dexmedetomidine 0.3group

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.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine 0.3

Intervention Type DRUG

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.

Control group

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Patients received over 10 minutes comparable volume of normal saline (0.9%) 15 min after endotracheal intubation followed by infusion.

Interventions

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Dexmedetomidine 0.6

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

Dexmedetomidine 0.3

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

Saline

Patients received over 10 minutes comparable volume of normal saline (0.9%) 15 min after endotracheal intubation followed by infusion.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Zeinab Tawfik

Assistant lecturer in Anesthesiology, Surgical ICU and Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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33360/09/19

Identifier Type: -

Identifier Source: org_study_id