Dexmedetomidine, Hemodynamic Changes, Intubation, Laparoscopic Bariatric Surgery, Morbid Obesity, Nebulization, Pneumoperitoneum
Conditions
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.
Interventions
DRUGDexmedetomidine
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.
DRUGNormal 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.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of increase in hemodynamic response | Intraoperatively | Incidence of increase in hemodynamic response, either heart rate, mean arterial pressure, or both. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative fentanyl consumption | Intraoperatively | Intraoperative fentanyl consumption will be recorded. |
| Intraoperative propofol consumption | Intraoperatively | Intraoperative propofol consumption will be recorded. |
| 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. |
| 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. |
| 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. |
Countries
Egypt
Outcome results
None listed