Effect of Induction and Maintenance of Anesthesia With Etomidate on Hemodynamics and Oxidative Stress in Diabetic Patients

NCT ID: NCT02202239

Last Updated: 2014-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To explore the effect of induction and maintenance of anesthesia with etomidate on hemodynamics and oxidative stress in diabetic patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemodynamics Oxidative Stress Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group E

Etomidate was used in both induction and maintenance of anesthesia.

Group Type EXPERIMENTAL

midazolam

Intervention Type DRUG

Before induction, midazolam 0.05mg/kg will be injected intravenously.

Penehyclidine Hydrochloride Injection

Intervention Type DRUG

Penehyclidine Hydrochloride 0.01mg/kg will be injected intravenously after midazolam is injected.

Etomidate

Intervention Type DRUG

Induction dose: 0.3 mg/kg. Maintenance dose: 10 μg•kg-1•min-1.

Fentanyl

Intervention Type DRUG

During induction, after injection of etomidate, fentanyl 3 μg/kg will be given intravenously.

Cisatracurium Besilate

Intervention Type DRUG

Cisatracurium Besilate 0.14 mg/kg will be used after fentanyl is injected for induction.

During maintenance, intermittent bolus of cisatracurium will be used for maintain muscle relaxation.

Remifentanil

Intervention Type DRUG

Remifentanil will be injected continuously during maintenance of anesthesia.

Sevoflurane

Intervention Type DRUG

Sevoflurane of 1% to 2% will be administered via inhalation to keep bispectral index(BIS) between 50 to 55.

Group P

Propofol was used in both induction and maintenance of anesthesia.

Group Type ACTIVE_COMPARATOR

midazolam

Intervention Type DRUG

Before induction, midazolam 0.05mg/kg will be injected intravenously.

Propofol

Intervention Type DRUG

Induction dose: 2.0 mg/kg. Maintenance dose: 4 to 6 mg/kg/h.

Fentanyl

Intervention Type DRUG

During induction, after injection of etomidate, fentanyl 3 μg/kg will be given intravenously.

Cisatracurium Besilate

Intervention Type DRUG

Cisatracurium Besilate 0.14 mg/kg will be used after fentanyl is injected for induction.

During maintenance, intermittent bolus of cisatracurium will be used for maintain muscle relaxation.

Remifentanil

Intervention Type DRUG

Remifentanil will be injected continuously during maintenance of anesthesia.

Sevoflurane

Intervention Type DRUG

Sevoflurane of 1% to 2% will be administered via inhalation to keep bispectral index(BIS) between 50 to 55.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

midazolam

Before induction, midazolam 0.05mg/kg will be injected intravenously.

Intervention Type DRUG

Penehyclidine Hydrochloride Injection

Penehyclidine Hydrochloride 0.01mg/kg will be injected intravenously after midazolam is injected.

Intervention Type DRUG

Etomidate

Induction dose: 0.3 mg/kg. Maintenance dose: 10 μg•kg-1•min-1.

Intervention Type DRUG

Propofol

Induction dose: 2.0 mg/kg. Maintenance dose: 4 to 6 mg/kg/h.

Intervention Type DRUG

Fentanyl

During induction, after injection of etomidate, fentanyl 3 μg/kg will be given intravenously.

Intervention Type DRUG

Cisatracurium Besilate

Cisatracurium Besilate 0.14 mg/kg will be used after fentanyl is injected for induction.

During maintenance, intermittent bolus of cisatracurium will be used for maintain muscle relaxation.

Intervention Type DRUG

Remifentanil

Remifentanil will be injected continuously during maintenance of anesthesia.

Intervention Type DRUG

Sevoflurane

Sevoflurane of 1% to 2% will be administered via inhalation to keep bispectral index(BIS) between 50 to 55.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Li Yue Xi Chang Tuo Ning Fu Er Li

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Aged between 18 and 65 years;
* Diabetic patients preparing for elective surgery;
* Body mass index is between 16 and 30 kg/m2;
* Blood glucose is under 8.3 mmol/kg by oral antidiabetic agents or diet control;
* American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ;
* Expected operation duration is between 2 and 8 h;
* Signed informed consent form.

Exclusion Criteria

* Severe cardiac, cerebral, liver, kidney, lung, endocrine disease or infectious disease;
* Chemotherapy or immunotherapy before the surgery;
* Allergy to trial drug or other contraindication;
* Expected or history of difficult airway;
* Suspected abuse of narcotic analgesia;
* Diseases of neuromuscular system;
* Mentally unstable or has a mental illness;
* Trend of malignant hyperthermia;
* Pregnant or breast-feeding women;
* Attendance of other trial past 30 days.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zhujiang Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20140723

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dexmedetomidine in IVRA
NCT05123170 COMPLETED PHASE4