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

Not Applicable

Recruiting

• Conditions: Nebulization; Dexmedetomidine; Hemodynamic Changes; Intubation; Pneumoperitoneum; Morbid Obesity; Laparoscopic Bariatric Surgery
• Interventions: Drug: Dexmedetomidine; Drug: Normal Saline

• Registration Number: NCT07054138
• Lead Sponsor: Tanta University

Brief 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.

Study Timeline

• Study First Submitted: 2025-06-03
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-02
• Study First Posted: 2025-07-08
• Study Start: 2025-07-10
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-11
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine group	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	Normal Saline	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.

Primary Outcome Measures

Name	Time	Method
Incidence of increase in hemodynamic response	Intraoperatively	Incidence of increase in hemodynamic response, either heart rate, mean arterial pressure, or both.

Secondary Outcome Measures

Name	Time	Method
Preoperative sedation score	Preoperatively	Preoperative sedation score will be assessed using (Ramsay Sedation Scale): (1) Awake; agitated or restless or both, (2) Awake; cooperative, oriented and tranquil, (3) Awake but response to commands only,(4) Asleep; brisk response to light glabellar tab or loud auditory, (5) A sleep; sluggish response to light glabellar tab or loud auditory stimulus , (6) sleep; no response to glabellar tab or loud auditory stimulus.
Intraoperative fentanyl consumption	Intraoperatively	Intraoperative fentanyl consumption will be recorded.
Intraoperative propofol consumption	Intraoperatively	Intraoperative propofol consumption will be recorded.
Time for first use of rescue analgesia	24 hours postoperatively	Time for first use of rescue analgesia will be assessed from the end of surgery till first dose of morphine administrated.
Total opioid consumption	24 hours postoperatively	After assessment of pain scores, when numerical rating scale (NRS) measures more than 3; patients will receive 3mg morphine, which can be repeated considering that the total daily consumption of morphine never exceeds 20 mg.
Incidence of adverse effects	24 hours postoperatively	Incidence of adverse effects such as nausea, vomiting, bradycardia, hypotension or hypoxia will be recorded.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt