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Dexmedetomidine Reduces Sevoflurane MAC-BAR During Pneumoperitoneum

NCT06575179 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-10-01

No results posted yet for this study

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.

Conditions

  • Laparoscopic Cholecystectomy

Interventions

DRUG

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.

DRUG

normal Saline

The control group received volume-matched 0.9% saline infusions at identical rates.

DRUG

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.

Sponsors & Collaborators

  • Fujian Provincial Hospital

    lead OTHER

Principal Investigators

  • Xiaochun Zheng, MD&PhD · Fujian Provincial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-02
Primary Completion
2024-12-30
Completion
2024-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06575179 on ClinicalTrials.gov