Median Effective Dose of Esketamine Pretreatment to Prevent Sufentanil-induced Cough

April 11, 2023 updated by: Zhuan Zhang, Yangzhou University
Sufentanil has the advantages of fast onset time, strong analgesic function and cardiovascular stability, and is widely used during general anesthesia induction. However, sufentanil can cause cough during induction of general anesthesia. Different studies have reported that the incidence of sufentanil-induced cough ( SIC ) during anesthesia is 16-42 %. This pathological condition may lead to damage to the central nervous system, increase the risk of reflux and aspiration, increase intracranial pressure and intraocular pressure, and endanger patients with cerebral aneurysms and ocular trauma. Therefore, at the moment of advocating comfortable anesthesia medical services, sufentanil-induced cough response is a problem that clinical anesthesiologists need to focus on and urgently solve. It has been reported that ketamine can reduce the incidence of cough caused by opioids. Esketamine is a pure dextro-enantiomer of ketamine and an NMDA antagonist with potent analgesic and bronchodilator effects. In this study, Dixon sequential method was used to study the median effective dose ( ED50 ) of intravenous esketamine pretreatment to prevent sufentanil-induced cough, and to explore the effect of age on ED50. To provide reference for clinical rational selection of esketamine dose.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

ASA I-II patients aged 18-59 years undergoing elective surgery under general anesthesia

Exclusion Criteria:

  1. Preoperative intracranial pressure;
  2. intra-abdominal pressure or intraocular pressure increased ;
  3. have a history of cardiovascular and cerebrovascular diseases ;
  4. have a history of asthma ;
  5. have a history of chronic cough ;
  6. have a history of smoking ;
  7. there was a history of upper respiratory tract infection 2 weeks before operation;
  8. Patients received opioid therapy 2 weeks before surgery.;
  9. Patients who received angiotensin converting enzyme inhibitors, bronchodilators or steroids 2 weeks before surgery ;
  10. abnormal liver and kidney function ; weight exceeded 20 % of the ideal weight ( male height - 100, female height - 105 ).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Age range of 18 to 44 years olds
The initial dose of esketamine was set as 0.06 mg / kg, and the injection time of esketamine was 5 s. One minute after injection of esketamine, sufentanil 0.4 μg / kg was injected within 5 s, and the number of coughs within 1 min after injection was recorded. According to the evaluation of sufentanil-induced cough, the dose of esketamine was adjusted. If the patient had no cough ( negative reaction ), the dose of esketamine in the next patient was reduced until the cough reaction occurred. If the patient had a cough reaction ( positive reaction ), the dose of esketamine in the next patient was increased until the cough disappeared. The dose ratio of adjacent esketamine was 1.1. Each group was selected from the previous patient with positive reaction until the 7 groups of positive and negative reactions appeared alternately, and the test was completed.
Drug: Esketamine
The initial dose of esketamine was set as 0.06 mg / kg, and the injection time of esketamine was 5 s. One minute after injection of esketamine, sufentanil 0.4 μg / kg was injected within 5 s, and the number of coughs within 1 min after injection was recorded. According to the evaluation of sufentanil-induced cough, the dose of esketamine was adjusted. If the patient had no cough ( negative reaction ), the dose of esketamine in the next patient was reduced until the cough reaction occurred. If the patient had a cough reaction ( positive reaction ), the dose of esketamine in the next patient was increased until the cough disappeared. The dose ratio of adjacent esketamine was 1.1. Each group was selected from the previous patient with positive reaction until the 7 groups of positive and negative reactions appeared alternately, and the test was completed.
Experimental: Age range of 45 to 59 years olds
The initial dose of esketamine was set as 0.06 mg / kg, and the injection time of esketamine was 5 s. One minute after injection of esketamine, sufentanil 0.4 μg / kg was injected within 5 s, and the number of coughs within 1 min after injection was recorded. According to the evaluation of sufentanil-induced cough, the dose of esketamine was adjusted. If the patient had no cough ( negative reaction ), the dose of esketamine in the next patient was reduced until the cough reaction occurred. If the patient had a cough reaction ( positive reaction ), the dose of esketamine in the next patient was increased until the cough disappeared. The dose ratio of adjacent esketamine was 1.1. Each group was selected from the previous patient with positive reaction until the 7 groups of positive and negative reactions appeared alternately, and the test was completed.
Drug: Esketamine
The initial dose of esketamine was set as 0.06 mg / kg, and the injection time of esketamine was 5 s. One minute after injection of esketamine, sufentanil 0.4 μg / kg was injected within 5 s, and the number of coughs within 1 min after injection was recorded. According to the evaluation of sufentanil-induced cough, the dose of esketamine was adjusted. If the patient had no cough ( negative reaction ), the dose of esketamine in the next patient was reduced until the cough reaction occurred. If the patient had a cough reaction ( positive reaction ), the dose of esketamine in the next patient was increased until the cough disappeared. The dose ratio of adjacent esketamine was 1.1. Each group was selected from the previous patient with positive reaction until the 7 groups of positive and negative reactions appeared alternately, and the test was completed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The presence of cough
Time Frame: an average of 1 minutes
Yes or No
an average of 1 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The levels of cough
Time Frame: an average of 1 minutes
No cough: 0 times ; mild: 1-2 times ; moderate: 3-5 times ; severe: > 5 times
an average of 1 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yangzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20230325

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esketamine

Clinical Trials on Esketamine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings