Clinical trial

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

Name

33360/09/19

Description

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.

Trial arms

Trial start

2019-09-01

Estimated PCD

2021-09-30

Trial end

2021-09-30

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

Dexmedetomidine 0.6 group

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.

Arms:

Dexmedetomidine 0.3group

Saline

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

Arms:

Control group

Size

Primary endpoint

Intraoperative oxygenation

Intraoperative

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}

Updated at

2023-08-31

1 organization

1 product

1 drug

4 indications

Organization

Tanta University

Product

Dexmedetomidine

Indication

Anesthesia