Dexmedetomidine Clinical Trial
Official title:
Effect of Dexmedetomidine on Perioperative Internal Environment and Rehabilitation of Patients Undergoing Gastrointestinal Malignant Tumor Resection
Verified date | February 2021 |
Source | Yangzhou University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Dexmedetomidine is a highly selective alpha2-adrenergic receptor agonist with sedative, analgesic, anti-anxiety, and inhibitory sympathetic nerve excitation properties. It is commonly used in clinical anesthesia and intensive care.Radical gastrectomy for gastrointestinal malignant tumors is a common major operation in clinical practice, with long operation time, great trauma and strong stress response of patients. Dexmedetomidine is often used in general anesthesia during such operations, but its long-term use or large dose may produce certain side effects.Common side effects of dexmedetomidine include bradycardia and hypotension, etc. Previous studies have reported that dexmedetomidine can prolong QT interval and is at risk of causing tip torsion type ventricular tachycardia.Abnormal Potassium may affect myocardial repolarization and increase the risk of tip torsion ventricular tachycardia.The main purpose of this study was to observe the effects of long-term use of dexmedetomidine on perioperative internal environment such as electrolyte and rehabilitation indicators during radical general anesthesia for gastrointestinal malignancy, and the secondary purpose was to explore the optimal dose of dexmedetomidine for general anesthesia for patients undergoing radical general anesthesia for gastrointestinal malignancy.
Status | Completed |
Enrollment | 140 |
Est. completion date | August 30, 2020 |
Est. primary completion date | August 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. American Society of Anesthesiologists (ASA) physical status I or II; 2. age between 50-75 years, and a body mass index (BMI) between 18.5-28 kg/m2. Exclusion Criteria: 1. Patients whoused hormones or drugs that have a hypoglycemic nature during the preoperative state, or had bradycardia, arrhythmia, hypotension, abnormal liver or kidney function, pancreatic disease, neuroendocrine malignancy, intraoperative blood transfusion; 2. Patients who refused participation and those who needed intensive care after the surgery were also excluded from the study; 3. Patients who had severe internal environmental disorders. |
Country | Name | City | State |
---|---|---|---|
China | the Affiliated Hospital of Yangzhou University | Yangzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Yangzhou University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | drugs | the dosage of propofol, remifentanil and ephedrine | 1 day | |
Other | blood pressure | records the systolic blood pressure(mmHg), diastolic blood pressure(mmHg), and mean blood pressure(mmHg) of preoperative (T1), after infusion of loading dose of dexmedetomidine (T2), operation start (T3), operation start 5 min (T4), operation start 10 min (T5), operation start 1 h (T6), operation end(T7), immediately after extubation (T8), 5 min after extubation (T9) and into PACU 30 minutes (T10) | into PACU 30 minutes | |
Other | heart rate | records the heart rate(beats/minute) of preoperative (T1), after infusion of loading dose of dexmedetomidine (T2), operation start (T3), operation start 5 min (T4), operation start 10 min (T5), operation start 1 h (T6), operation end(T7), immediately after extubation (T8), 5 min after extubation (T9) and into PACU 30 minutes (T10) | into PACU 30 minutes | |
Primary | age | the age(years) | perioperative | |
Primary | weight | weight(kg) | perioperative | |
Primary | height | height(m) | perioperative | |
Primary | sex | sex(male/female) | perioperative | |
Primary | ASA status | ASA status of patients | perioperative | |
Secondary | internal environment | the concentrations of sodium(mmol/L), lactate(mmol/L), potassium(mmol/L), calcium(mmol/L), base excess(mmol/L), base excess in the extracellular fluid compartment(mmol/L) were measured before the dexmedetomidine infusion (t1), 1 h after the surgery began (t2), at the end of the surgery (t3), and 1 h after transfer to the PACU (t4), 24h after the surgery | Day 1 |
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