Dexmedetomidine Combined With the Closed Loop of Target Controlled Infusion of Propofol for Anesthesia With Intraoperative Wake up

July 3, 2014 updated by: Second Affiliated Hospital of Xi'an Jiaotong University

Dexmedetomidine Combined With the Closed Loop of Target Controlled Infusion of Propofol for Anesthesia With Intraoperative Wake Up-single Center,Random,Controlled Trial

The study designed to explore the efficacy and safety of the closed loop of target controlled infusion dexmedetomidine combined with propofol for anesthesia with intraoperative wake up.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

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.
60

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.
  • Phase 4

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent.
  • Ongoing brain functional area surgery with intraoperative wake up.
  • American Society of Anesthesiologists class I to II.
  • Aged between 18 and 65 years old.
  • Weight between plus or minus 20% of the standard weight. Male: (height cm - 80) × 70% = standard weight Female: (height cm - 70) × 60% = standard weight

Exclusion Criteria:

  • History of hypertension.
  • Serious heart,brain,liver,kidney, pulmonary, and endocrine disease or serious infection.
  • Mental disability or mental disease.
  • Use of sedative drug.
  • Suspected or confirmed long term use of narcotic analgesics.
  • Inability to exchange.
  • Suspected or confirmed difficult airway.
  • Suspected of malignant hyperthermia.
  • Neuromuscular disease.
  • Allergic to investigational products or with other contraindication.
  • Subjects who are breastfeeding or pregnant.
  • Participated in other study within 30 days .

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: Dexmedetomidine group
  1. Infusion of dexmedetomidine(0.8μg/kg) at10 minutes before anesthesia induction.
  2. Infusion of dexmedetomidine at 0.4 μg•kg-1•h-1during anesthesia maintenance.
  3. The infusion rate of dexmedetomidine was reduced to 0.1 μg•kg-1•h-1 for awaken test.
Drug: Anesthesia induction,propofol, remifentanil ,cisatracurium
  1. Target Controlled Infusion propofol and remifentanil to targeted plasma concentrations are 4 μg/ ml and 4 ng/ml respectively.
  2. Intermittent injection cisatracurium (0.15mg/kg).
  3. A laryngeal mask airway will be placed when bispectral electroencephalogram index is reduced to 60.
Drug: Anesthesia maintenance , propofol,remifentanil,cisatracurium
  1. Closed-loop target controlled infusion of propofol ,Bispectral electroencephalogram index feedback value will be set at 50.
  2. Target Controlled Infusion remifentanil , targeted plasma concentrations are 3~6ng/ml ,maintain heart rate to 60~100 beats per minute and mean blood pressure to 70~105 mmHg.
  3. Intermittent injection cisatracurium (0.05mg/kg).
Procedure: Awaken test
  1. Stopped Closed-loop target controlled infusion of cisatracurium and propofol 30 minutes before awaken test.
  2. In dexmedetomidine group,dexmedetomidine infusion rate will be reduced to 0.1 μg•kg-1•h-1. In control group ,normal saline infusion will be given with the same infusion rate as dexmedetomidine group .
  3. Call patients' name and require them to move both feet every 30 seconds after patients recovered normal respiration.
  4. Patients will be considered to be awake when recover normal respiration and make responsive to verbal commands correctly .
  5. Patients will receive initial anesthesia after finish awaken test.
Placebo Comparator: Control group
  1. Infusion normal saline(0.8μg/kg) at 10 minutes before anesthesia induction.
  2. Infusion normal saline at 0.4 μg•kg-1•h-1 during anesthesia maintenance.
  3. The infusion rate of normal saline was reduced to 0.1 μg•kg-1•h-1 for awaken test.
Drug: Anesthesia induction,propofol, remifentanil ,cisatracurium
  1. Target Controlled Infusion propofol and remifentanil to targeted plasma concentrations are 4 μg/ ml and 4 ng/ml respectively.
  2. Intermittent injection cisatracurium (0.15mg/kg).
  3. A laryngeal mask airway will be placed when bispectral electroencephalogram index is reduced to 60.
Drug: Anesthesia maintenance , propofol,remifentanil,cisatracurium
  1. Closed-loop target controlled infusion of propofol ,Bispectral electroencephalogram index feedback value will be set at 50.
  2. Target Controlled Infusion remifentanil , targeted plasma concentrations are 3~6ng/ml ,maintain heart rate to 60~100 beats per minute and mean blood pressure to 70~105 mmHg.
  3. Intermittent injection cisatracurium (0.05mg/kg).
Procedure: Awaken test
  1. Stopped Closed-loop target controlled infusion of cisatracurium and propofol 30 minutes before awaken test.
  2. In dexmedetomidine group,dexmedetomidine infusion rate will be reduced to 0.1 μg•kg-1•h-1. In control group ,normal saline infusion will be given with the same infusion rate as dexmedetomidine group .
  3. Call patients' name and require them to move both feet every 30 seconds after patients recovered normal respiration.
  4. Patients will be considered to be awake when recover normal respiration and make responsive to verbal commands correctly .
  5. Patients will receive initial anesthesia after finish awaken test.

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
Time Frame
Success rate of awaken test
Time Frame: The whole time of surgery,about 8 hours
The whole time of surgery,about 8 hours
The time from starting to awaken test to patient wakes up
Time Frame: From starting to awaken test to patient wakes up,about 3 hours
From starting to awaken test to patient wakes up,about 3 hours
Blood sugar concentration
Time Frame: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Cortisol concentration
Time Frame: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Epinephrine concentration
Time Frame: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Norepinephrine concentration
Time Frame: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test

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
Time Frame
The duration of anesthesia from baseline to patient wake up
Time Frame: From baseline to patient wake up ,about 3 hours
From baseline to patient wake up ,about 3 hours
The dosage of Cisatracurium before patient wakes up
Time Frame: From starting to awaken test to patient wakes up,about 3 hours
From starting to awaken test to patient wakes up,about 3 hours
The dosage of propofol before patient wakes up
Time Frame: From starting to awaken test to patient wakes up,about 3 hours
From starting to awaken test to patient wakes up,about 3 hours
The dosage of remifentanil before patient wakes up
Time Frame: From starting to awaken test to patient wakes up,about 3 hours
From starting to awaken test to patient wakes up,about 3 hours
Heart rate
Time Frame: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Mean arterial pressure
Time Frame: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
Bispectral electroencephalogram index
Time Frame: 30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test
30 minutes prior to awaken test,the moment of awake,5 minutes after awake,the moment after finish awaken test,10minutes after finish awaken test

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.
Second Affiliated Hospital of Xi'an Jiaotong 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

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.
June 1, 2014

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.
December 1, 2015

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).
May 15, 2014

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.
May 20, 2014

First Posted (Estimate)

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.
May 21, 2014

Study Record Updates

Last Update Posted (Estimate)

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.
July 4, 2014

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.
July 3, 2014

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.
July 1, 2014

More Information

Terms related to this study

Keywords

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.
  • Dex anesthesia

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