Application of Dexmedetomidine Hydrochloride Injection in Anesthesia for Patients Without Tracheal Intubation

NCT04652427 | Unknown

• 1 other identifier: 2020PHC003
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

With 0.9% sodium chloride injection as a placebo control, to evaluate the effectiveness and safety of dexmedetomidine hydrochloride injection for sedation in patients with non-tracheal intubation

Conditions

Sedation Complication

Keywords

effectiveness; security; Dexmedetomidine Hydrochloride; Non-tracheal intubation anesthetic

Outcome Measures

Primary Outcomes (1)

• Changes in the OAA/S score of the subject during the study medication.

  At least 15 minutes before anesthesia, the study drug was given sedation according to the dosing schedule. At the end of the loading dose of the study drug, an alertness/sedation score (OAA/S) was performed, and then it entered the maintenance dosing phase, which was performed every 5 minutes until the end of the operation OAA/S score. OAA/S≤4 means that the required level of sedation has been reached, and anesthesia can be performed after starting the study drug for ≥15 minutes and reaching the required level of sedation. During the administration of the study drug, OAA/S ≤4 should always be maintained.

  15min after giving the drug, every five minutes during anesthesia

Study Arms (2)

Use Dexmedetomidine Hydrochloride to maintain a sedative

EXPERIMENTAL

Slow static injection at a load-loaded dose of 1.0/g/kg (half of the load dose in ophthalmology surgery), infusion time of 10 to 15 min, followed by the maintenance phase, maintenance dose set at an initial 0.6/g/kg/h, maintenance during administration The researchers, using the results of the OAA/S assessment, made a comprehensive judgment to adjust the infusion rate in the range of 0.2 to 1.0/g/kg/h to obtain the desired sedative effect, and anaesthetic can be performed when the study drug was given a duration of 15 minutes and the required sedative level was reached. Maintain the administration until the end of the operation.

Drug: Dexmedetomidine Hydrochloride 0.1 MG/ML

Sedative were maintained with a 0.9% sodium chloride injection

PLACEBO COMPARATOR

Slow static injection at a load-loaded dose of 1.0/g/kg (half of the load dose in ophthalmology surgery), infusion time of 10 to 15 min, followed by the maintenance phase, maintenance dose set at an initial 0.6/g/kg/h, maintenance during administration The researchers, using the results of the OAA/S assessment, made a comprehensive judgment to adjust the infusion rate in the range of 0.2 to 1.0/g/kg/h to obtain the desired sedative effect, and anaesthetic can be performed when the study drug was given a duration of 15 minutes and the required sedative level was reached. Maintain the administration until the end of the operation.

Drug: 0.9% Sodium Chloride Injection

Interventions

Dexmedetomidine Hydrochloride 0.1 MG/ML DRUG

At least 15 min prior to anesthesia is sedated by the study drug given according to the administration protocol, an alert/sedative score (OAA/S) is performed at the end of the drug load dose administration, and then the maintenance-giving phase is then performed at the end of the operation with an OAA/S score every 5 min. Anestheticing can be performed after the required level of sedation has been reached. OAA/S 4 should always be maintained during drug administration.

Also known as: sedation

Use Dexmedetomidine Hydrochloride to maintain a sedative

0.9% Sodium Chloride Injection DRUG

At least 15 min prior to anesthesia is sedated by the study drug given according to the administration protocol, an alert/sedative score (OAA/S) is performed at the end of the drug load dose administration, and then the maintenance-giving phase is then performed at the end of the operation with an OAA/S score every 5 min. Anestheticing can be performed after the required level of sedation has been reached. OAA/S 4 should always be maintained during drug administration.

Also known as: saline solution

Sedative were maintained with a 0.9% sodium chloride injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 18\~65 years old (including 18 and 65 years old), no gender limit;
• \) 18 kg/m2 ≤BMI≤30 kg/m2;
• \) For patients undergoing elective surgery under non-general anesthesia, the expected duration of surgery is ≥30min;
• \) ASA classification is Ⅰ～Ⅲ;
• \) After the patient has a full understanding of the purpose and significance of this trial, he/she voluntarily participates in this clinical trial, agrees to contraception during the study period and within 3 days after the study medication, and signs an informed consent Intent.

You may not qualify if:

• \) Patients who have received anesthesia or surgery within 7 days before randomization;
• \) Patients with a history of acute myocardial infarction or unstable angina within 6 months before the screening period;
• \) Bradycardia (heart rate \<50 beats/min), Ⅱ or Ⅲ degree atrioventricular block (not including Patients with pacemakers) and other severe arrhythmia and heart failure;
• \) Hypertension patients who are not satisfactorily controlled (systolic blood pressure ≥160 mmHg, and/or diastolic blood pressure ≥100 mmHg), or patients with hypotension (systolic blood pressure \<90 mmHg);
• \) People with mental system diseases (such as schizophrenia, depression, etc.) or cognitive impairment; Those with a history of epilepsy;
• \) Those who suffer from bronchial asthma or other severe respiratory diseases;
• \) Abnormal blood coagulation function (PT prolongation exceeds the upper limit of normal for 3 seconds and/or APTT prolongation exceeds. The upper limit of the normal value is 10 seconds);
• \) Abnormal liver and kidney function (ALT and/or AST\>2 times the upper limit of normal, total bilirubin\>1.5 Times the upper limit of normal, blood creatinine\>1.5 times the upper limit of normal);
• \) Those who have used α2 adrenergic receptor agonists or antagonists within 14 days before randomization;
• \) Those who have used sedatives such as benzodiazepines and barbiturates within 7 days before randomization;
• \) People with a history of drug abuse, drug abuse and alcohol abuse, among which alcohol abuse is defined as the average daily drinking Liquor exceeds 2 units of alcohol (1 unit = 360 ml of beer or 45 ml of alcohol is 40% white wine or 150 ml wine);
• \) Those who are allergic to dexmedetomidine, midazolam, fentanyl and other pharmaceutical ingredients or components;
• \) Women who are pregnant or breastfeeding;
• \) Those who have participated in other clinical trials within 3 months before randomization;
• \) The researcher believes that there are any other circumstances that are not suitable for selection.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (1)

• Candiotti KA, Bergese SD, Bokesch PM, Feldman MA, Wisemandle W, Bekker AY; MAC Study Group. Monitored anesthesia care with dexmedetomidine: a prospective, randomized, double-blind, multicenter trial. Anesth Analg. 2010 Jan 1;110(1):47-56. doi: 10.1213/ane.0b013e3181ae0856. Epub 2009 Aug 27.

  PMID: 19713256 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Sodium Chloride; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yi Feng, MD,PhD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Feng, MD,PhD

CONTACT

86-010-88325581; yifeng65@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of anesthesiology and pain management

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: December 3, 2020
• Study Start: August 20, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2022
• Last Updated: December 3, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)