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

Tanta University

Status: Completed

Conditions: Pneumoperitoneum; Hemodynamic Changes; Dexmedetomidine; Laparoscopic Bariatric Surgery; Morbid Obesity; Intubation; Nebulization

Treatments: Drug: Dexmedetomidine; Drug: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT07054138

KFSIRB200-20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from 20 to 60 years old.
• 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

• Patients' refusal
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

Dexmedetomidine group

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Normal Saline