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

NCT ID: NCT04771637

Last Updated: 2021-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dexmedetomidine Perioperative Electrolyte

Keywords

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Dexmedetomidine Electrolyte Haemodynamics Rehabilitation Internal environment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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control with normal saline

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Normal saline is used to observe the effect on the electrophysiology and quality of recovery of the patients

dexmedetomidine loading dose 1 µg/kg + maintenance dose 0.25 µg/kg/h

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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 loading dose 0.5 µg/kg + maintenance dose 0.5 µg/kg/h

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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 loading dose 1 µg/kg + maintenance dose 0.5 µg/kg/h

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Normal saline

Normal saline is used to observe the effect on the electrophysiology and quality of recovery of the patients

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yangzhou University

OTHER

Sponsor Role lead

Responsible Party

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Zhuan Zhang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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20210213

Identifier Type: -

Identifier Source: org_study_id