Effect of Dexmedetomidine on Perioperative Internal Environment and Rehabilitation of Patients Undergoing Gastrointestinal Malignant Tumor Resection

Dexmedetomidine Clinical Trial

Official title:

Effect of Dexmedetomidine on Perioperative Internal Environment and Rehabilitation of Patients Undergoing Gastrointestinal Malignant Tumor Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04771637
• Other study ID #: 20210213
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: August 30, 2020

Study information

• Verified date: February 2021
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Dexmedetomidine
• Electrolyte
• Neoplasms
• Perioperative

Intervention

Drug:
• Dexmedetomidine
The loading dose with 0.5 µg/kg, maintenance dose with 0.5 µg/kg of Dexmedetomidine is used to observe the effect on the electrolyte and quality of recovery of the patients
• Dexmedetomidine
The loading dose with 1.0 µg/kg, maintenance dose with 0.25 µg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology and quality of recovery of the patient
• Dexmedetomidine
The loading dose with 1 µg/kg, maintenance dose with 0.5 µg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology and quality of recovery of the patients
• Normal saline
Normal saline is used to observe the effect on the electrophysiology and quality of recovery of the patients

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

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