Preoperative Nebulized Dexmedetomidine on Hemodynamic Changes in Laparoscopic Bariatric Surgery.

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

Detailed Description
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Dexmedetomidine is an α -2 adrenergic agonist that has been proven to attenuate the hemodynamic response to intubation and pneumoperitoneum along with dose sparing effect on opioids and propofol .It has been used in multiple routes such as intravenous, intramuscular, oral, nasal, or intrathecal routes .Inhalation of nebulized drug is noninvasive and associated with high bioavailability .Nebulized Dexmedetomidine may offer an attractive alternative to both intravenous as well as intranasal routes of administration because drug deposition following nebulization takes place over nasal, buccal, as well as respiratory mucosa.

Official Title
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Effect of Preoperative Nebulized Dexmedetomidine on Hemodynamic Changes in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery.

Conditions
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Dexmedetomidine, Hemodynamics, Laparoscopic Bariatric Surgery

Intervention / Treatment
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* Drug: Saline
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: This study will include 90 adult morbidly obese patients of both sex with BMI (40-50), (ASA) III physical status, aged between 18 -50 years scheduled for elective laparoscopic bariatric surgery under general anesthesia. Exclusion Criteria: Patient's refusal. Decompensated hepatic or renal or cardiac disease. Expected difficult airway management. Uncontrolled hypertension. Psychiatric disease. Sever pulmonary disorders. Patients on opioid, alcohol, beta-blockers or allergy to any of the study drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Patients of this group will be Nebulized with 3 mL of 0.9% saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position. | Drug: Saline<br>* Patients will be Nebulized with 3 mL of 0.9% saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position.<br>|
| Experimental: Study group<br>Patients of this group will be Nebulized with Dexmedetomidine (1 mcg/kg) in 3mL of 0.9% saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position. | Drug: Dexmedetomidine<br>* Patients will be Nebulized with Dexmedetomidine (1 mcg/kg) in 3mL of 0.9% saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic response to laryngoscope, and pneumoperitoneum. | Heart rate (HR) and non-invasive mean arterial blood pressure (MAP) changes before nebulization, after nebulization, immediately after induction, after intubation at (1-3-6 minutes), post-pneumoperitoneum(T0) then every 15 minutes till end of the surgery. | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of sedation | Ramsay Sedation Scale). Awake; agitated or restless or both. Awake; cooperative, oriented, and tranquil. Awake but responds to commands only. Asleep; brisk response to light glabellar tap or loud auditory. Asleep; sluggish response to light glabellar tap or loud auditory stimulus. sleep; no response to glabellar tap or loud auditory stimulus. | Just after nebulization | 
| Amount of opioid consumption | After assessment of pain scores, when NRS measures more than (3), patients will receive 3 mg morphine, which can be repeated considering that the total daily consumption of morphine never exceeds 20 mg. | 24 hours postoperative | 
| Amount of fentanyl consumption | Additional doses of fentanyl (50 mcg) will be given if HR and MAP unexplained increased more than 20% from base line during surgery, and total consumption of fentanyl will be recorded, patients in whom the first attempt of tracheal intubation have failed will be rulled out from the study. | Intraoperative | 
| Postoperative pain | Postoperative pain will be measured using numerical rating scale (NRS) where (0 = no pain, 10 = the worst possible pain), postoperative pain will be assessed 30 minutes postoperatively then at ( 2,4,6,12,18,24 hours). | 24 hours postoperative |