DexmedetomidineNCT06014359
Preoperative Nebulized Dexmedetomidine on Hemodynamic Changes in Laparoscopic Bariatric Surgery.
A study testing Saline and Dexmedetomidine in people with Dexmedetomidine and Hemodynamics, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dexmedetomidine, Hemodynamics, Laparoscopic Bariatric Surgery
- What is being tested?
- Saline and Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Aug 2023to 1 Feb 2024
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, ElGharbia, 31527
Abdelhamed I Badreldin, MBBCH, 00201090690631, ai0751294@gmail.com
Abdelraheem M Dowidar, MD
About this study
Official title: Effect of Preoperative Nebulized Dexmedetomidine on Hemodynamic Changes in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery.
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.
Read the 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.
- Being tested
- Saline, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
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.
DexmedetomidineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | 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. Receives: Drug: Saline |
| Study group | Experimental | 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. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic response to laryngoscope, and pneumoperitoneum.
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.
Measured: Intraoperative
Secondary outcomes (4)
Degree of sedation
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.
Measured: Just after nebulization
Amount of opioid consumption
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.
Measured: 24 hours postoperative
Amount of fentanyl consumption
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.
Measured: Intraoperative
Postoperative pain
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).
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start27 Aug 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelhamed Ibrahim Abdelhamed Badreldin, Tanta University
- Investigators
- Abdelhamed I Badreldin, MBBCH, Principal investigator, Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014359
- Sponsor's protocol ID
- 36264MS150/4/23
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- 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 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Nebulized Dexmedetomidine on Hemodynamic Changes in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery.
- ClinicalTrials.gov ID
- NCT06014359
- Acronym / sponsor ID
- 36264MS150/4/23
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 27 Aug 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 28 Aug 2023 (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 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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: SalinePatients 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. |
| Study group | Experimental | Drug: DexmedetomidinePatients 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- Patient's refusal.
- Decompensated hepatic or 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 |
|---|---|---|
| SalinePatients 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 | Control group |
| DexmedetomidinePatients 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 | Study group |
Primary outcome
Hemodynamic response to laryngoscope, and pneumoperitoneum.
Time frame: 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.
4 secondary outcomes
Degree of sedation
Time frame: Just after nebulization
Amount of opioid consumption
Time frame: 24 hours postoperative
Amount of fentanyl consumption
Time frame: Intraoperative
Postoperative pain
Time frame: 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- 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.
Abdelhamed I Badreldin, MBBCH principal investigator
Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline and Dexmedetomidine in people with Dexmedetomidine and Hemodynamics, 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 1 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: status not confirmed, as of the sponsor's last update on 31 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelhamed I Badreldin, MBBCH (00201090690631, ai0751294@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic response to laryngoscope, and pneumoperitoneum. (time frame: Intraoperative). 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 31 Aug 2023.