NCT04771637

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
Last Updated

November 30, 2021

Status Verified

February 1, 2021

Enrollment Period

3.7 years

First QC Date

February 13, 2021

Last Update Submit

November 29, 2021

Conditions

DexmedetomidinePerioperativeElectrolyte

Keywords

DexmedetomidineElectrolyteHaemodynamicsRehabilitationInternal environment

Outcome Measures

Primary Outcomes (5)

  • age

    the age(years)

    perioperative

  • weight

    weight(kg)

    perioperative

  • height

    height(m)

    perioperative

  • sex

    sex(male/female)

    perioperative

  • ASA status

    ASA status of patients

    perioperative

Secondary Outcomes (1)

  • internal environment

    Day 1

Other Outcomes (3)

  • drugs

    1 day

  • blood pressure

    into PACU 30 minutes

  • heart rate

    into PACU 30 minutes

Study Arms (4)

control with normal saline

PLACEBO COMPARATOR
Drug: Normal saline

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

EXPERIMENTAL
Drug: Dexmedetomidine

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

EXPERIMENTAL
Drug: Dexmedetomidine

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

EXPERIMENTAL
Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

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 1 µg/kg + maintenance dose 0.25 µg/kg/h
Normal salineDRUG

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

control with normal saline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, 225012, China

Location

MeSH Terms

Interventions

DexmedetomidineSaline Solution

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 13, 2021

First Posted

February 25, 2021

Study Start

January 1, 2017

Primary Completion

August 30, 2020

Study Completion

August 30, 2020

Last Updated

November 30, 2021

Record last verified: 2021-02

Locations

CN(1)