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

Sponsor

Yangzhou University (Other)

Overall Status

Completed

CT.gov ID

NCT04771637

Collaborator

(none)

140

Enrollment

Location

Arms

43.9

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Dexmedetomidine Perioperative Electrolyte	Drug: Dexmedetomidine Drug: Dexmedetomidine Drug: Dexmedetomidine Drug: Normal saline	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Aug 30, 2020

Actual Study Completion Date :

Aug 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: control with normal saline	Drug: Normal saline Normal saline is used to observe the effect on the electrophysiology and quality of recovery of the patients
Experimental: dexmedetomidine loading dose 1 µg/kg + maintenance dose 0.25 µg/kg/h	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
Experimental: dexmedetomidine loading dose 0.5 µg/kg + maintenance dose 0.5 µg/kg/h	Drug: 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
Experimental: dexmedetomidine loading dose 1 µg/kg + maintenance dose 0.5 µg/kg/h	Drug: 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

Outcome Measures

Primary Outcome Measures

age [perioperative]
the age(years)
weight [perioperative]
weight(kg)
height [perioperative]
height(m)
sex [perioperative]
sex(male/female)
ASA status [perioperative]
ASA status of patients

Secondary Outcome Measures

internal environment [Day 1]
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

Other Outcome Measures

drugs [1 day]
the dosage of propofol, remifentanil and ephedrine
blood pressure [into PACU 30 minutes]
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)
heart rate [into PACU 30 minutes]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status I or II;
age between 50-75 years, and a body mass index (BMI) between 18.5-28 kg/m2.

Exclusion Criteria:

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;
Patients who refused participation and those who needed intensive care after the surgery were also excluded from the study;
Patients who had severe internal environmental disorders.