NebulizationNCT07054138
Efficacy of Nebulized Dexmedetomidine on Blunting Hemodynamic Changes During Intubation and Pneumoperitoneum in Morbid Obese Patients During Laparoscopic Bariatric Surgery
A study testing Dexmedetomidine and Normal Saline in people with Nebulization and Dexmedetomidine, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Nebulization, Dexmedetomidine, Hemodynamic Changes
- What is being tested?
- Dexmedetomidine and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Nebulization, Dexmedetomidine, Hemodynamic Changes, Intubation, Pneumoperitoneum, Morbid Obesity
- Being tested
- Dexmedetomidine, Normal Saline
- Medical subject headings
- Pneumoperitoneum, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
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 SalineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | 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. Receives: Drug: Dexmedetomidine |
| Control group | Placebo comparator | Patients will be nebulized with 3 ml of 0.9% normal saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of increase in hemodynamic response
Incidence of increase in hemodynamic response, either heart rate, mean arterial pressure, or both.
Measured: Intraoperatively
Secondary outcomes (6)
Preoperative sedation score
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.
Measured: Preoperatively
Intraoperative fentanyl consumption
Intraoperative fentanyl consumption will be recorded.
Measured: Intraoperatively
Intraoperative propofol consumption
Intraoperative propofol consumption will be recorded.
Measured: Intraoperatively
Time for first use of rescue analgesia
Time for first use of rescue analgesia will be assessed from the end of surgery till first dose of morphine administrated.
Measured: 24 hours postoperatively
Total opioid consumption
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.
Measured: 24 hours postoperatively
Incidence of adverse effects
Incidence of adverse effects such as nausea, vomiting, bradycardia, hypotension or hypoxia will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start10 Jul 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NebulizationStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMED ABDELAZIZ SHAMA, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054138
- Sponsor's protocol ID
- KFSIRB200-20
- Status last verified
- Dec 2025
- First submitted
- 3 Jun 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07054138
- Acronym / sponsor ID
- KFSIRB200-20
- Conditions
- Nebulization, Dexmedetomidine, Hemodynamic Changes, Intubation, Pneumoperitoneum, Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: DexmedetomidinePatients 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. |
| Control group | Placebo comparator | Drug: Normal SalinePatients will be nebulized with 3 ml of 0.9% normal saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Patients' refusal
- Decompansated hepatic, renal, or cardiac disease
- Expected difficult airway management
- Uncontrolled hypertension
- Psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidinePatients 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. | Drug | Dexmedetomidine group |
| Normal SalinePatients 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. | Drug | Control group |
Primary outcome
Incidence of increase in hemodynamic response
Time frame: Intraoperatively
Incidence of increase in hemodynamic response, either heart rate, mean arterial pressure, or both.
6 secondary outcomes
Preoperative sedation score
Time frame: Preoperatively
Intraoperative fentanyl consumption
Time frame: Intraoperatively
Intraoperative propofol consumption
Time frame: Intraoperatively
Time for first use of rescue analgesia
Time frame: 24 hours postoperatively
Total opioid consumption
Time frame: 24 hours postoperatively
Incidence of adverse effects
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Normal Saline in people with Nebulization and Dexmedetomidine, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of increase in hemodynamic response (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.