An interventional study of Mechanical Ventilation and Midazolam in Intestinal Microbiota and Mechanical Ventilation, sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. Withdrawn at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-28.
Sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Not applicable, Interventional, and Other
Bidirectional communication between the CNS and the GI tract - the brain-gut axis - occurs both in health and disease.Patients with mechanical ventilation in ICU (ICU) often meet the necessary nutritional needs. These patients often appear varying degrees of intestinal flora imbalance, such as diarrhea, vomiting, abdominal distension and other complications, which exert negative effect on treatment and prolong hospitalization time.So far，whether the sedative drugs used for a long time in mechanically ventilated patients will affect the diversity of intestinal flora or not has not been reported.The effects of different sedative drugs on the intestinal flora diversity need further study.Therefore, this topic will used midazolam and dexmedetomidine to study the effect on the diversity of intestinal microbiota.Meanwhile，the research will provide a theoretical basis for rational use of mechanical ventilation and sedative drugs.
There are a variety of normal microbial communities in the healthy human intestines, which maintain the physiological balance of the host. Under normal circumstances, there are about 104 intestinal microflora in the adult's intestines. The total number of genes is about 150 times the number of human genes. More and more studies have found that intestinal flora plays an important role in the occurrence of many human diseases. In recent years, the role of intestinal microflora in the brain axis has gradually been recognized and become a hot spot of research, and a new concept of the brain - gut axis is proposed.
The brain-gut axis is a bidirectional communication system between the central nervous system (CNS) and the gastrointestinal tract. Compared with ordinary mice, mild exposure to pressure can increase the level of corticosterone and adrenocorticotropic hormone in sterile mice, and this overreaction can be reversed by transplantation of normal rats' feces.Together, it is clear that the gut microbiota can be a key regulator of mood, cognition, pain, and obesity. Understanding microbiota-brain interactions is an exciting area of research which may contribute new insights into individual variations in cognition, personality, mood, sleep, and eating behavior.The abnormal expression of GABA (GABA) receptor in central nervous system is related to anxiety and depression. It is found that probiotics can regulate the expression of GABA receptor in the cerebral cortex through vagus nerve, thereby reducing anxiety and depression.5-HT signal system abnormalities may be associated with the pathophysiological changes of irritable bowel syndrome (IBS), while intestinal flora can affect the generation of neurotransmitter 5-HT in the intestine, resulting in changing of gastrointestinal motility and sensibility of internal organ. The above study means that the brain axis plays an important role in maintaining the diversity of intestinal microbiota.
It is essential that using sedatives to maintain the safety and comfort of the patient in ICU.Most patients also need receiving mechanical ventilation.Many patients in Intensive care unit appear varying degrees of intestinal microflora imbalance,especially received mechanical ventilation.So far,whether sedatives used for a long time in mechanically ventilated patients will affect the diversity of intestinal flora or not still not been reported. The effects of different sedative drugs on the intestinal flora diversity also need further study.Therefore, the topic will discuss the diversity of intestinal microbiota in patients with different sedative-hypnotics and mechanical ventilation.
Exclusion Criteria:
Patients who requires the mechanical ventilation allocated to the midazolam group (group M) were treated with an infusion bolus of 0.05 mg/kg and continuous infusion of 0.04 to 0.20 mg/kg/hour, with the dosage adjusted to achieve the desired level of sedation.
Device: Mechanical Ventilation · Drug: Midazolam
Patients who requires the mechanical ventilation allocated to the dexmedetomidine group (group D) received an infusion bolus of 1 ug/kg within 10 minutes and continuous infusion of 0.25 to 0.75 ug/kg/hour, with the dosage adjusted to achieve the desired level of sedation.All patients maintained BIS between 65\~85 and the Ramsay score was 3 to 4.
Device: Mechanical Ventilation · Drug: Dexmedetomidine
Whether midazolam and dexmedetomidine have an effect on the diversity of intestinal microbiota or not is still unknown，especially the patient who requires the mechanical ventilation.
The impact of Midazolam on the diversity of intestinal microbiota.
Also known as: Midazolam injection
The impact of dexmedetomidine on the diversity of intestinal microbiota.
Also known as: Dexmedetomidine injection
The changing trends of the diversity of Intestinal microbiota
Bacterial diversity revealed by 16S ribosomal RNA (rRNA) gene high-throughput sequencing (HTS).Feces were collected before operation from patients who had surgery.After the first collection, another was collected when the patient received mechanical ventilation more than 12 hours.
Time frame: Up to 1 year from the beginning of the study
The changing trends of weight
The changing trends of weight was recorded in kilograms by the experimental assistant
Time frame: Up to 1 month from the beginning of the study
duration of sedation
BIS and Ramsay score were described by the anesthetist physician
Time frame: Time from achieving sedation until reaching full consciousness,up to 1 week.
Duration of mechanical ventilation
Duration of mechanical ventilation was described by the anesthetist physician
Time frame: Up to 3 days from the beginning of the study
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University