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Completed

NCT Number: NCT07054138

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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.

normal saline

Drug

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.

Primary outcomes

  1. Incidence of increase in hemodynamic response

    Time frame: Intraoperatively

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

Secondary outcomes

  1. Preoperative sedation score

    Time frame: 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.

  2. Intraoperative fentanyl consumption

    Time frame: Intraoperatively

    Intraoperative fentanyl consumption will be recorded.

  3. Intraoperative propofol consumption

    Time frame: Intraoperatively

    Intraoperative propofol consumption will be recorded.

  4. Time for first use of rescue analgesia

    Time frame: 24 hours postoperatively

    Time for first use of rescue analgesia will be assessed from the end of surgery till first dose of morphine administrated.

  5. Total opioid consumption

    Time frame: 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.

  6. Incidence of adverse effects

    Time frame: 24 hours postoperatively

    Incidence of adverse effects such as nausea, vomiting, bradycardia, hypotension or hypoxia will be recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Pre-operative Study the Efficacy of Nebulized Dexmedetomidine on Blunting Hemodynamic Changes During Intubation and Pneumoperitoneum in Morbid Obese Patients During Laparoscopic Bariatric Surgery: Randomized Double Blind Control Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 8, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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