Acceptable Hemodynamic Changes in Dexmedetomidine for Single Intravenous Bolus Injection

Delirium Clinical Trial

Official title:

Determination of ED50 and ED95 of Single Bolus Dexmedetomidine in General Anesthesia Patients to Produce Acceptable Hemodynamic Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03655847
• Other study ID #: LCKY2018-32
• Status: Recruiting
• Phase: Phase 4
• Start date: May 23, 2018
• Est. completion date: April 23, 2020

Study information

• Verified date: September 2019
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: Huacheng Liu
• Phone: 18957755138
• Email: huachengliu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Patients undergoing thyroidectomy under general anesthesia were treated with routine anesthesia induction and maintenance, and DEX 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 DEX was 0.1 ug/kg. If the cardiovascular reaction was positive (MAP or heart rate was more than 20% before intravenous injection), the dosage of DEX in the next patient decreased by a gradient (0.05ug/kg). If the cardiovascular response was negative, the next patient increased the dose of DEX 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. There were 8 turning points of cardiovascular reaction and the test was completed. The changes of blood pressure and heart rate per minute in 10min were recorded after single bolus. The dosimetric map of patients with DEX was drawn, and the ED50 and ED95 were calculated by probit probabilistic unit regression (Bills method).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: April 23, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. volunteer to participate in the study and sign the informed consent;

2. selective operation of thyroid gland whose anesthesia time is less than 2 hours ;

3. aged 18-55 years;

4. ASA I - II;

5. BMI 18~28kg/m2.

Exclusion Criteria:

1. Mallampati grade ? or ?;

2. opening degree < 2.5 cm;

3. taking analgesic or sedative drugs for a long time before operation;

4. a history of arrhythmia, bronchial and cardiovascular diseases, abnormal liver function and so on;

5. allergic to dexmedetomidine, similar active ingredients or excipients;

6. G-6-PD deficiency;

7. a history of use of alpha 2 receptor agonists or antagonists.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Dexmedetomidine
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.

Locations

Country	Name	City	State
China	The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate(HR)	HR changes per minutes in 10 minutes after single injection of DEX	10min
Secondary	Duration of operation	Duration of operation	intraoperative, from the beginning of the cut to the end of the seam
Secondary	Anaesthesia time	Anaesthesia time	intraoperative, from initiation of anesthesia induction to cessation of anesthetic use
Secondary	Recovery time of anesthesia	Recovery time of anesthesia	within 24 hours
Secondary	Mean arterial pressure(MAP)	MAP changes per minutes in 10 minutes after single injection of DEX	10min