Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575179
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-25
Brief Title:
Dexmedetomidine Reduces Sevoflurane MAC-BAR During Pneumoperitoneum
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Dexmedetomidine on Sevoflurane Minimum Alveolar Concentration for Attenuating Adrenergic Response to CO2 Pneumoperitoneum A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 09 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
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 09 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 bodys 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 bodys 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 sympatheticstress 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 bodys 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 bodys 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 sympatheticstress response to the inflated gas used in laparoscopic surgery
The anesthetic drug sevoflurane is commonly used during these procedures but higher doses are needed to adequately block the bodys 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 sympatheticstress 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 bodys 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 bodys 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 sympatheticstress response to the inflated gas used in laparoscopic surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None