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Completed

NCT Number: NCT04771637

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

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.

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Key information

Conditions

Dexmedetomidine Electrolyte periOperative

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, 225012, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

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

normal saline

Drug

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

Primary outcomes

  1. age

    Time frame: perioperative

    the age(years)

  2. weight

    Time frame: perioperative

    weight(kg)

  3. height

    Time frame: perioperative

    height(m)

  4. sex

    Time frame: perioperative

    sex(male/female)

  5. ASA status

    Time frame: perioperative

    ASA status of patients

Secondary outcomes

  1. internal environment

    Time frame: 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 outcomes

  1. drugs

    Time frame: 1 day

    the dosage of propofol, remifentanil and ephedrine

  2. blood pressure

    Time frame: 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)

  3. heart rate

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Yangzhou University

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 25, 2021
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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