Acceptable Hemodynamic Changes in Dexmedetomidine for Single Intravenous Bolus Injection

NCT03655847 | Unknown Phase 4 FDA Drug

• 1 other identifier: LCKY2018-32
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Dexmedetomidine（DEX）is a potent and highly selective α 2 adrenergic receptor agonist. It has the pharmacological effects of sedation, hypnosis, analgesia, anti-sympathetic and neuroprotective. Its sedative effect is similar to normal sleep, and easy to wake up. DEX is widely used clinically because of its advantages and acceptable side effects. The best clinical use of DEX is uncertain, including intravenous, intramuscular, oral, intralnasal and sublingual administration. Its clinical recommended use is intravenous load infusion for more than 10 minutes, followed by continuous infusion. However, the clinical recommended usage is inconvenient, time-consuming and other shortcomings, for the growing popularity of daytime surgery, will inevitably affect the operation process and turnover. If a suitable dose range of DEX can be found for a single intravenous injection to achieve clinical efficacy quickly without significant hemodynamic effects, this will improve the patient's postoperative recovery. We will speed up the utilization and turnover of medical resources. The aim of this study was to investigate the optimal dosage of DEX for single intravenous injection.

Conditions

Delirium; Postoperative Complications; Pathologic Processes; Neurocognitive Disorders; Mental Disorders; Dexmedetomidine; Hypnotics and Sedatives; Physiological Effects of Drugs; Analgesics; Molecular Mechanisms of Pharmacological Action

Outcome Measures

Primary Outcomes (1)

• Heart rate(HR)

  HR changes per minutes in 10 minutes after single injection of DEX

  10min

Secondary Outcomes (4)

• Duration of operation

  intraoperative, from the beginning of the cut to the end of the seam

• Anaesthesia time

  intraoperative, from initiation of anesthesia induction to cessation of anesthetic use

• Recovery time of anesthesia

  within 24 hours

• Mean arterial pressure(MAP)

  10min

Study Arms (1)

Dexmedetomidine

EXPERIMENTAL

Drug: Dexmedetomidine dexmedetomidine, 0.1ug/kg up or down Other Name: precedex

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Dexmedetomidine was injected intravenously 30 minutes before the end of operation. Single bolus is for more than 1 minute. In the first case, the dosage of dexmedetomidine was 0.1 ug/kg. If the cardiovascular reaction was positive (mean arterial pressure or heart rate was more than 20% before intravenous injection), the dosage of Dexmedetomidine in the next patient decreased by a gradient (0.05ug/kg). If the cardiovascular response was negative, the next patient increased the dose of dexmedetomidine by a gradient (0.1ug/kg); if a patient withdrew from the study, the next patient received the same dose as the patient who withdrew.

Also known as: see arms

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• volunteer to participate in the study and sign the informed consent;
• selective operation of thyroid gland whose anesthesia time is less than 2 hours ;
• aged 18-55 years;
• ASA I - II;
• BMI 18\~28kg/m2.

You may not qualify if:

• Mallampati grade Ⅲ or Ⅳ;
• opening degree \< 2.5 cm;
• taking analgesic or sedative drugs for a long time before operation;
• a history of arrhythmia, bronchial and cardiovascular diseases, abnormal liver function and so on;
• allergic to dexmedetomidine, similar active ingredients or excipients;
• G-6-PD deficiency;
• a history of use of alpha 2 receptor agonists or antagonists.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

RECRUITING

MeSH Terms

Conditions

Delirium; Postoperative Complications; Pathologic Processes; Neurocognitive Disorders; Mental Disorders

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jun Li

  The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Huacheng Liu

CONTACT

18957755138; huachengliu@163.com

Chengyu Wang

CONTACT

15158719196; 2322313983@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: August 31, 2018
• Study Start: May 23, 2018
• Primary Completion: March 23, 2020
• Study Completion: April 23, 2020
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study complettion.
• Access Criteria: Data access request will be reviewed by an external independent review panel.Requestors will be required to sign a Data access agreement.

Locations

CN (1)