Efficacy of Nebulized Dexmedetomidine on Blunting Hemodynamic Changes During Intubation and Pneumoperitoneum in Morbid Obese Patients During Laparoscopic Bariatric Surgery
NCT ID: NCT07054138
Last Updated: 2025-12-23
Study Results
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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COMPLETED
NA
90 participants
INTERVENTIONAL
2025-07-10
2025-11-30
Brief Summary
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Detailed Description
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Direct laryngoscopy and intubation are noxious stimuli that are associated with transient, unpredictable, and variable hemodynamic changes. This response occurs within 30 seconds after intubation and lasts less than 10 minutes. The consequences of laryngoscopy and intubation may precipitate ischemia, arrhythmias, cerebrovascular stroke, pulmonary oedema, and an increase in the intracranial pressure in the vulnerable group.
Dexmedetomidine is an α2 adrenergic agonist that has been proven to attenuate the hemodynamic response to intubation and pneumoperitoneum, along with a dose-sparing effect on opioids and propofol. It has been used in multiple routes, including intravenous, intramuscular, oral, nasal, and intrathecal routes. Inhalation of the nebulized drug is non-invasive and associated with high bioavailability. Nebulized dexmedetomidine may offer an attractive alternative to both intravenous and intranasal routes of administration, as drug deposition following nebulization occurs over the nasal, buccal, and respiratory mucosa.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dexmedetomidine group
Patients will be nebulized with dexmedetomidine 1 mcg/kg in 3 ml of 0.9 % saline 15 minutes before shifting the patients to the operating room with a face mask 6 L/min in a sitting position.
Dexmedetomidine
Patients will be nebulized with dexmedetomidine 1 mcg/kg in 3 ml of 0.9 % saline 15 minutes before shifting the patients to the operating room with a face mask 6 L/min in a sitting position.
Control group
Patients will be nebulized with 3 ml of 0.9% normal saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position.
Normal Saline
Patients will be nebulized with 3 ml of 0.9% normal saline 15 minutes before shifting the patients to the operating room with a face mask, 6 L/min in a sitting position.
Interventions
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Dexmedetomidine
Patients will be nebulized with dexmedetomidine 1 mcg/kg in 3 ml of 0.9 % saline 15 minutes before shifting the patients to the operating room with a face mask 6 L/min in a sitting position.
Normal Saline
Patients will be nebulized with 3 ml of 0.9% normal saline 15 minutes before shifting the patients to the operating room with a face mask, 6 L/min in a sitting position.
Eligibility Criteria
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Inclusion Criteria
* Both sexes.
* American Society of Anesthesiologists (ASA) Physical Status I-III.
* Morbidly obese patients with a body mass index (BMI) between 30 and 45.
Exclusion Criteria
* Decompansated hepatic, renal, or cardiac disease
* Expected difficult airway management
* Uncontrolled hypertension
* Psychiatric disease
* Sever pulmonary disease
* Patients on opioid, alcohol, beta-blockers, or allergy to any of the study drugs.
20 Years
60 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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AHMED ABDELAZIZ SHAMA
Assistant Professor of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Locations
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Tanta University
Tanta, El-Gharbia, Egypt
Countries
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Other Identifiers
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KFSIRB200-20
Identifier Type: -
Identifier Source: org_study_id