Dexmedetomidine Reduces Sevoflurane MAC-BAR During Pneumoperitoneum

NCT06575179 | Recruiting Phase 4 DMC

• 1 other identifier: k2022-12-004
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 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

Keywords

dexmedetomidine; MAC-BAR; sevoflurane; laparoscopic surgery; α2-adrenergic receptor agonist

Outcome Measures

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.

  Within 30 minutes after intubation

Secondary Outcomes (3)

• Change in mean arterial pressure

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

• Change in heart rate

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

• Incidence of adverse events

  Up to 24 hours postoperatively

Study Arms (3)

Control group

PLACEBO COMPARATOR

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

Drug: normal Saline

Low-dose dexmedetomidine group

EXPERIMENTAL

The low-dose dexmedetomidine group received a 75 μg/h loading dose over 15 minutes, followed by 60 μg/h maintenance infusion intravenously.

Drug: Dexmedetomidine low-dose

High-dose dexmedetomidine group

EXPERIMENTAL

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

Drug: Dexmedetomidine high-dose

Interventions

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.

Also known as: dexmedetomidine hydrochloride Injection

Low-dose dexmedetomidine group

normal Saline DRUG

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

Control group

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.

Also known as: dexmedetomidine hydrochloride Injection

High-dose dexmedetomidine group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Aged 18-45 years.
• \. American Society of Anesthesiologists (ASA) grade I - II.
• \. Patients undergoing elective laparoscopic cholecystectomy.

You may not qualify if:

• \. Inability to provide informed consent;
• \. History of chronic pain or substance abuse;
• \. Pregnancy;
• \. Body mass index (BMI) ≥ 30 kg/m2;
• \. Known allergies to the study medications;
• \. Intake of medications within the last 72 hours that potential interfere with the determination of the MAC-BAR;

Sponsors & Collaborators

• Fujian Provincial Hospital: lead

Study Sites (1)

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Xiaochun Zheng, MD&PhD

  Fujian Provincial Hospital

  STUDY CHAIR

Central Study Contacts

Yusheng Yao, MD&PhD

CONTACT

13559939629; fjslyys@fjmu.edu.cn

Sisi Chen, MD

CONTACT

15080109541; css@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: August 28, 2024
• Study Start: September 2, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The investigators would like to share the individual deidentified participant data from the three months following the publication of the main results.
• Access Criteria: All the individual participant data collected during the trial, the study protocol, the statistical analysis plan, and the clinical study report can be accessed with approval from the corresponding author.

Locations

CN (1)