Dexmedetomidine Reduces Sevoflurane MAC-BAR During Pneumoperitoneum
NCT ID: NCT06575179
Last Updated: 2024-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
90 participants
INTERVENTIONAL
2024-09-02
2024-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
DEXDES Trial: Dexmedetomidine-Desflurane Combination in Laparoscopic Colectomy
NCT07239479
Dexmedetomidine to Improve Outcomes During Emergence From Retroperitoneal Laparoscopic Surgery
NCT02316236
Comparison Of Dexmedetomidine and Fentanyl In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy.
NCT04089592
The Impact of a Single Dexmedetomidine Bolus on Intraoperative Sevoflurane Consumption (DEXHALE)
NCT05615194
Effect of Different Doses of Dexmedetomidine on Cerebral Oxygen Saturation and Postoperative Anxiety in Elderly Patients
NCT05640427
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control group
The control group received volume-matched 0.9% saline infusions at identical rates.
normal Saline
The control group received volume-matched 0.9% saline infusions at identical rates.
Low-dose dexmedetomidine group
The low-dose dexmedetomidine group received a 75 μg/h loading dose over 15 minutes, followed by 60 μg/h maintenance infusion intravenously.
Dexmedetomidine low-dose
The 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
The high-dose dexmedetomidine group received a 150 μg/h loading dose over 15 minutes, followed by 120 μg/h maintenance infusion intravenously.
Dexmedetomidine high-dose
The high-dose dexmedetomidine group received a 150 μg/h loading dose over 15 minutes, followed by 120 μg/h maintenance infusion intravenously.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dexmedetomidine low-dose
The low-dose dexmedetomidine group received a 75 μg/h loading dose over 15 minutes, followed by 60 μg/h maintenance infusion intravenously.
normal Saline
The control group received volume-matched 0.9% saline infusions at identical rates.
Dexmedetomidine high-dose
The high-dose dexmedetomidine group received a 150 μg/h loading dose over 15 minutes, followed by 120 μg/h maintenance infusion intravenously.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 2\. American Society of Anesthesiologists (ASA) grade I - II.
* 3\. Patients undergoing elective laparoscopic cholecystectomy.
Exclusion Criteria
* 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.
18 Years
45 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fujian Provincial Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yao Yusheng
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xiaochun Zheng, MD&PhD
Role: STUDY_CHAIR
Fujian Provincial Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fujian Provincial Hospital
Fuzhou, Fujian, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yusheng Yao, Doctor
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
k2022-12-004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.