Dexmedetomidine Reduces Sevoflurane MAC-BAR During Pneumoperitoneum
NCT Number: NCT06575179
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Laparoscopic Cholecystectomy
Interventions: DRUG: Dexmedetomidine low-dose|DRUG: normal Saline|DRUG: Dexmedetomidine high-dose
Sponsor: Fujian Provincial Hospital
Sex: ALL
Age: ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-02
Completion Date: 2025-11-30
Locations: Fujian Provincial Hospital, Fuzhou, Fujian, 350001, China

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. 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.

Primary Outcome Measures: 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., Within 30 minutes after intubation
Secondary Outcome Measures: 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., 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., 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., Up to 24 hours postoperatively