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Dexmedetomidine Reduces Sevoflurane MAC-BAR During Pneumoperitoneum

ConditionLaparoscopic Cholecystectomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-45
SponsorFujian Provincial Hospital

About this 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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Aged 18-45 years.

2. American Society of Anesthesiologists (ASA) grade I - II.

3. Patients undergoing elective laparoscopic cholecystectomy.

Disqualifiers

1. Inability to provide informed consent;

2. History of chronic pain or substance abuse;

3. Pregnancy;

4. Body mass index (BMI) ≥ 30 kg/m2;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine low-dose

    Drug

    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

    Drug

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

  • Dexmedetomidine high-dose

    Drug

    The high-dose dexmedetomidine group received a 150 μg/h loading dose over 15 minutes, followed by 120 μg/h maintenance infusion intravenously.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Control groupPlacebo comparator 1 intervention
Group B: Low-dose dexmedetomidine groupExperimental treatment 1 intervention
Group C: High-dose dexmedetomidine groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 30 minutes after intubation

Secondary outcomes

1

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.

Time frame
Upon arrival in the operating room, at 3, 1 minutes before pneumoperitoneum and 1, 3 minutes after pneumoperitoneum
2

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.

Time frame
Upon arrival in the operating room, at 3, 1 minutes before pneumoperitoneum and 1, 3 minutes after pneumoperitoneum
3

Incidence of adverse events

Adverse events such as bradycardia, tachycardia, hypertension, hypotension, and hypoxia will be recorded during the trial.

Time frame
Up to 24 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Provincial Hospital

Lead sponsor

Source ClinicalTrials.gov
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