NCT07054138

Efficacy of Nebulized Dexmedetomidine on Blunting Hemodynamic Changes During Intubation and Pneumoperitoneum in Morbid Obese Patients During Laparoscopic Bariatric Surgery

Pre-operative Study the Efficacy of Nebulized Dexmedetomidine on Blunting Hemodynamic Changes During Intubation and Pneumoperitoneum in Morbid Obese Patients During Laparoscopic Bariatric Surgery: Randomized Double Blind Control Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the effect of preoperative dexmedetomidine nebulization on blunting hemodynamic response for laryngoscope, intubation, pneumoperitoneum, and opioid consumption in morbidly obese patients undergoing laparoscopic bariatric surgery.

Detailed description

Obesity is a major global public health issue. Morbidly obese patients have multiple pathophysiological changes that affect most of the body organs in the form of restrictive lung diseases, obstructive sleep apnea (OSA), hypertension, cardiovascular problems, metabolic syndrome, and fatty infiltration of the liver. 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

• Nebulization
• Dexmedetomidine
• Hemodynamic Changes
• Intubation
• Pneumoperitoneum
• Morbid Obesity
• Laparoscopic Bariatric Surgery

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2025-07-10
• Primary completion: 2025-11-30
• Completion: 2025-11-30
• First posted: 2025-07-08
• Last updated: 2025-12-23

Locations

1 site across 1 country: Egypt