Preoperative Nebulized Dexmedetomidine on Hemodynamic Changes in Laparoscopic Bariatric Surgery.

Tanta University

Status: Enrolling

Conditions: Dexmedetomidine; Laparoscopic Bariatric Surgery; Hemodynamics

Treatments: Drug: Dexmedetomidine; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06014359

36264MS150/4/23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

1. Patient's refusal.
2. Decompensated hepatic or renal or cardiac disease.
3. Expected difficult airway management.
4. Uncontrolled hypertension.
5. Psychiatric disease.
6. Sever pulmonary disorders.
7. 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

Control group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline

Study group

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine