Laparoscopic CholecystectomyPhase 4NCT06575179
Dexmedetomidine Reduces Sevoflurane MAC-BAR During Pneumoperitoneum
A Phase 4 study testing Dexmedetomidine low-dose, normal Saline and Dexmedetomidine high-dose in people with Laparoscopic Cholecystectomy, run by Fujian Provincial Hospital at 1 site in China.
Trial summary
This clinical trial aims to learn the impact of dexmedetomidine on the minimum alveolar concentration blunting the adrenergic response (MAC-BAR) of sevoflurane to carbon dioxide pneumoperitoneum in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Dexmedetomidine low-dose, normal Saline and Dexmedetomidine high-dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2024to 30 Dec 2024
- Phase
- Phase 4
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Aged 18-45 years.
- 2. American Society of Anesthesiologists (ASA) grade I - II.
- 3. Patients undergoing elective laparoscopic cholecystectomy.
Who cannot join
- 1. Inability to provide informed consent;
- 2. History of chronic pain or substance abuse;
- 3. Pregnancy;
- 4. Body mass index (BMI) ≥ 30 kg/m2;
- 5. Known allergies to the study medications;
- 6. Intake of medications within the last 72 hours that potential interfere with the determination of the MAC-BAR;
- 7. Any other condition deemed exclusionary by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
Yusheng Yao, Doctor
About this study
Official title: Effect of Dexmedetomidine on Sevoflurane Minimum Alveolar Concentration for Attenuating Adrenergic Response to CO2 Pneumoperitoneum: A Randomized Controlled Trial
This clinical trial aims to learn the impact of dexmedetomidine on the minimum alveolar concentration blunting the adrenergic response (MAC-BAR) of sevoflurane to carbon dioxide pneumoperitoneum in patients undergoing laparoscopic cholecystectomy. It will also learn about the effect of dexmedetomidine on hemodynamic parameters. The main questions are:
- Does dexmedetomidine reduce the MAC-BAR of sevoflurane required to suppress the sympathetic response to carbon dioxide pneumoperitoneum?
- Would dexmedetomidine administration dose-dependently reduce the minimum alveolar concentration blunting the adrenergic response of sevoflurane required to suppress the sympathetic response to carbon dioxide pneumoperitoneum? Researchers will compare low-dose dexmedetomidine to high-dose dexmedetomidine to see if dexmedetomidine works to treat postoperative negative behavior change and emergence delirium.
Read more
Participants will:
- Take intravenous dexmedetomidine or 0.9% saline (a look-alike substance that contains no drug)
- Study drug infusions were initiated 15 minutes prior to anesthesia induction, allowing a minimum of 30 minutes to elapse before surgical incision to achieve steady-state plasma and brain concentrations.
Read the detailed description
Laparoscopic (minimally invasive) surgery has several advantages over open surgery, including less tissue damage, faster recovery, and fewer complications. This has led to widespread use of laparoscopic techniques. However, the inflated carbon dioxide gas used to create the surgical space during laparoscopic surgery causes significant changes in the body's normal blood pressure and heart function.
The anesthetic drug sevoflurane is commonly used during these procedures, but higher doses are needed to adequately block the body's stress response to the inflated gas. The minimum alveolar concentration blunting the adrenergic response (MAC-BAR) measures the minimum anesthetic depth required to suppress the sympathetic/stress response in 50% of patients. Doctors use MAC-BAR values to help determine the appropriate anesthetic dose to maintain hemodynamic stability. Unfortunately, using higher sevoflurane doses to reach the necessary MAC-BAR increases the risk of low blood pressure, reduced heart function, and confusion after surgery.
The drug dexmedetomidine has properties that can help manage the body's stress response during surgery. Researchers wanted to see if dexmedetomidine could allow the use of lower, more stable doses of sevoflurane during laparoscopic procedures by reducing the body's reaction to the inflated gas.
The goal of this study was to evaluate how dexmedetomidine affects the MAC-BAR of sevoflurane needed to block the sympathetic/stress response to the inflated gas used in laparoscopic surgery.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Dexmedetomidine low-dose, normal Saline, Dexmedetomidine high-dose
- Keywords
- dexmedetomidine, MAC-BAR, sevoflurane, laparoscopic surgery, α2-adrenergic receptor agonist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine low-doseDrug
Also called dexmedetomidine hydrochloride Injection
The low-dose dexmedetomidine group received a 75 μg/h loading dose over 15 minutes, followed by 60 μg/h maintenance infusion intravenously.
normal SalineDrug
The control group received volume-matched 0.9% saline infusions at identical rates.
Dexmedetomidine high-doseDrug
Also called dexmedetomidine hydrochloride Injection
The high-dose dexmedetomidine group received a 150 μg/h loading dose over 15 minutes, followed by 120 μg/h maintenance infusion intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | The control group received volume-matched 0.9% saline infusions at identical rates. Receives: Drug: normal Saline |
| Low-dose dexmedetomidine group | Experimental | The low-dose dexmedetomidine group received a 75 μg/h loading dose over 15 minutes, followed by 60 μg/h maintenance infusion intravenously. Receives: Drug: Dexmedetomidine low-dose |
| High-dose dexmedetomidine group | Experimental | The high-dose dexmedetomidine group received a 150 μg/h loading dose over 15 minutes, followed by 120 μg/h maintenance infusion intravenously. Receives: Drug: Dexmedetomidine high-dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum alveolar concentration of sevoflurane to block the adrenergic response (MAC-BAR)
The MAC-BAR of sevoflurane for each group was determined using an up-and-down sequential allocation technique. One minute after establishing a stable pneumoperitoneum, the sympathetic adrenergic response was evaluated by changes in heart rate and mean artery pressure from pre-insufflation baseline values. A positive response was defined as a ≥ 20% increase in either heart rate or mean artery pressure from baseline.
Measured: Within 30 minutes after intubation
Secondary outcomes (3)
Change in mean arterial pressure
Change in blood pressure was calculated as the difference between pre-pneumoperitoneum and post-pneumoperitoneum. Pre-pneumoperitoneum mean arterial pressure was averaged from 3 and 1 minutes baseline values, while post-pneumoperitoneum value was averaged over 1 and 3 minutes after establishing insufflation.
Measured: Upon arrival in the operating room, at 3, 1 minutes before pneumoperitoneum and 1, 3 minutes after pneumoperitoneum
Change in heart rate
Change in blood pressure was calculated as the difference between pre-pneumoperitoneum and post-pneumoperitoneum. Pre-pneumoperitoneum heart rate was averaged from 3 and 1 minutes baseline values, while post-pneumoperitoneum value was averaged over 1 and 3 minutes after establishing insufflation.
Measured: Upon arrival in the operating room, at 3, 1 minutes before pneumoperitoneum and 1, 3 minutes after pneumoperitoneum
Incidence of adverse events
Adverse events such as bradycardia, tachycardia, hypertension, hypotension, and hypoxia will be recorded during the trial.
Measured: Up to 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 posted28 Aug 2024
- Study start2 Sep 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao Yusheng, Fujian Provincial Hospital
- Investigators
- Xiaochun Zheng, MD&PhD, Study chair, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575179
- Sponsor's protocol ID
- k2022-12-004
- Status last verified
- Sep 2024
- First submitted
- 25 Aug 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication, the individual deidentified participant data underlying published results, the study protocol, and the statistical analysis plan can be accessed upon reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on Sevoflurane Minimum Alveolar Concentration for Attenuating Adrenergic Response to CO2 Pneumoperitoneum: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06575179
- Acronym / sponsor ID
- k2022-12-004
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- dexmedetomidine, MAC-BAR, sevoflurane, laparoscopic surgery, α2-adrenergic receptor agonist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 28 Aug 2024 (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 clinical trial aims to learn the impact of dexmedetomidine on the minimum alveolar concentration blunting the adrenergic response (MAC-BAR) of sevoflurane to carbon dioxide pneumoperitoneum in patients undergoing laparoscopic cholecystectomy. It will also learn about the effect of dexmedetomidine on hemodynamic parameters. The main questions are:
- Does dexmedetomidine reduce the MAC-BAR of sevoflurane required to suppress the sympathetic response to carbon dioxide pneumoperitoneum?
- Would dexmedetomidine administration dose-dependently reduce the minimum alveolar concentration blunting the adrenergic response of sevoflurane required to suppress the sympathetic response to carbon dioxide pneumoperitoneum? Researchers will compare low-dose dexmedetomidine to high-dose dexmedetomidine to see if dexmedetomidine works to treat postoperative negative behavior change and emergence delirium.
Participants will:
- Take intravenous dexmedetomidine or 0.9% saline (a look-alike substance that contains no drug)
- Study drug infusions were initiated 15 minutes prior to anesthesia induction, allowing a minimum of 30 minutes to elapse before surgical incision to achieve steady-state plasma and brain concentrations.
Detailed description
Laparoscopic (minimally invasive) surgery has several advantages over open surgery, including less tissue damage, faster recovery, and fewer complications. This has led to widespread use of laparoscopic techniques. However, the inflated carbon dioxide gas used to create the surgical space during laparoscopic surgery causes significant changes in the body's normal blood pressure and heart function.
The anesthetic drug sevoflurane is commonly used during these procedures, but higher doses are needed to adequately block the body's stress response to the inflated gas. The minimum alveolar concentration blunting the adrenergic response (MAC-BAR) measures the minimum anesthetic depth required to suppress the sympathetic/stress response in 50% of patients. Doctors use MAC-BAR values to help determine the appropriate anesthetic dose to maintain hemodynamic stability. Unfortunately, using higher sevoflurane doses to reach the necessary MAC-BAR increases the risk of low blood pressure, reduced heart function, and confusion after surgery.
The drug dexmedetomidine has properties that can help manage the body's stress response during surgery. Researchers wanted to see if dexmedetomidine could allow the use of lower, more stable doses of sevoflurane during laparoscopic procedures by reducing the body's reaction to the inflated gas.
The goal of this study was to evaluate how dexmedetomidine affects the MAC-BAR of sevoflurane needed to block the sympathetic/stress response to the inflated gas used in laparoscopic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: normal SalineThe control group received volume-matched 0.9% saline infusions at identical rates. |
| Low-dose dexmedetomidine group | Experimental | Drug: Dexmedetomidine low-doseThe low-dose dexmedetomidine group received a 75 μg/h loading dose over 15 minutes, followed by 60 μg/h maintenance infusion intravenously. |
| High-dose dexmedetomidine group | Experimental | Drug: Dexmedetomidine high-doseThe high-dose dexmedetomidine group received a 150 μg/h loading dose over 15 minutes, followed by 120 μg/h maintenance infusion intravenously. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1. Aged 18-45 years.
- 2. American Society of Anesthesiologists (ASA) grade I - II.
- 3. Patients undergoing elective laparoscopic cholecystectomy.
Key exclusion criteria (7 listed)
- 1. Inability to provide informed consent;
- 2. History of chronic pain or substance abuse;
- 3. Pregnancy;
- 4. Body mass index (BMI) ≥ 30 kg/m2;
- 5. Known allergies to the study medications;
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 |
|---|---|---|
| Dexmedetomidine low-doseAlso: dexmedetomidine hydrochloride InjectionThe low-dose dexmedetomidine group received a 75 μg/h loading dose over 15 minutes, followed by 60 μg/h maintenance infusion intravenously. | Drug | Low-dose dexmedetomidine group |
| normal SalineThe control group received volume-matched 0.9% saline infusions at identical rates. | Drug | Control group |
| Dexmedetomidine high-doseAlso: dexmedetomidine hydrochloride InjectionThe high-dose dexmedetomidine group received a 150 μg/h loading dose over 15 minutes, followed by 120 μg/h maintenance infusion intravenously. | Drug | High-dose dexmedetomidine group |
Primary outcome
Minimum alveolar concentration of sevoflurane to block the adrenergic response (MAC-BAR)
Time frame: Within 30 minutes after intubation
The MAC-BAR of sevoflurane for each group was determined using an up-and-down sequential allocation technique. One minute after establishing a stable pneumoperitoneum, the sympathetic adrenergic response was evaluated by changes in heart rate and mean artery pressure from pre-insufflation baseline values. A positive response was defined as a ≥ 20% increase in either heart rate or mean artery pressure from baseline.
3 secondary outcomes
Change in mean arterial pressure
Time frame: Upon arrival in the operating room, at 3, 1 minutes before pneumoperitoneum and 1, 3 minutes after pneumoperitoneum
Change in heart rate
Time frame: Upon arrival in the operating room, at 3, 1 minutes before pneumoperitoneum and 1, 3 minutes after pneumoperitoneum
Incidence of adverse events
Time frame: Up to 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Yes. After publication, the individual deidentified participant data underlying published results, the study protocol, and the statistical analysis plan can be accessed upon reasonable request from the corresponding author.
Related trials for Laparoscopic Cholecystectomy
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruitingObservational study
Assessment of Optic Sheat Diameter (ONSD) and Eyeball Transverse Diameter (ETD) Ratio Measurement From Ocular Ultrasound
Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Increase
Recruiting
US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy
Postoperative Pain
Enrolling by invitation
Heat Application and Shoulder Pillow for Post-Laparoscopic Shoulder Pain
Laparoscopic Cholecystectomy, Shoulder Pain
Active, not recruiting
Effect of Coffee Smelling on Pain, Physiological Parameters and Time to Discharge From Post Anesthesia Care Unit in Patients Undergoing Laparoscopic Cholecystectomy
Cholecystectomy, Laparoscopic
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.
Xiaochun Zheng, MD&PhD study chair
Fujian Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine low-dose, normal Saline and Dexmedetomidine high-dose in people with Laparoscopic Cholecystectomy, run by Fujian Provincial Hospital at 1 site in China.
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 3 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 1 Oct 2024. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yusheng Yao, MD&PhD (13559939629, fjslyys@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum alveolar concentration of sevoflurane to block the adrenergic response (MAC-BAR) (time frame: Within 30 minutes after intubation). 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 1 Oct 2024.