Preoperative Nebulized Dexmedetomidine on Hemodynamic Changes in Laparoscopic Bariatric Surgery.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Control group 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
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.
|
| Experimental: Study group 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
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.
|
Outcome Measures
Primary Outcome Measures
- Hemodynamic response to laryngoscope, and pneumoperitoneum. [Intraoperative]
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.
Secondary Outcome Measures
- Degree of sedation [Just after nebulization]
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.
- Amount of opioid consumption [24 hours postoperative]
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.
- Amount of fentanyl consumption [Intraoperative]
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.
- Postoperative pain [24 hours postoperative]
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).
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tanta University | Tanta | ElGharbia | Egypt | 31527 |
Sponsors and Collaborators
- Tanta University
Investigators
- Principal Investigator: Abdelhamed I Badreldin, MBBCH, Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 36264MS150/4/23