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

NCT02202239 | Unknown Phase 4 DMC

• 1 other identifier: 20140723
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hemodynamics; Oxidative Stress; Anesthesia

Outcome Measures

Primary Outcomes (7)

• Mean arterial pressure

  Mean arterial pressure will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.

  from 10 minutes before induction to 1 h after the surgery

• Central venous pressure

  Central venous pressure will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.

  from 10 minutes before induction to 1 h after the surgery

• Heart rate

  Heart rate will be recorded 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.

  from 10 minutes before induction to 1 h after the surgery

• Respiratory rate

  Respiratory rate will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.

  from 10 minutes before induction to 1 h after the surgery

• Oxygen saturation

  Oxygen saturation will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.

  from 10 minutes before induction to 1 h after the surgery

• Blood glucose

  Blood glucose will be measured 10 min before the induction (T0), at intubation (T1), 15 min (T2) after intubation, 1 h after the beginning of the surgery (T3), when the surgery is finished (T4) and 1 h after the end of the surgery (T5). Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.

  from 10 minutes before induction to 1 h after the surgery

• Insulin

  Insulin will be measured 10 min before the induction (T0), at intubation (T1), 15 min (T2) after intubation, 1 h after the beginning of the surgery (T3), when the surgery is finished (T4) and 1 h after the end of the surgery (T5). Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished.

  from 10 minutes before induction to 1 h after the surgery

Secondary Outcomes (3)

• Super oxide dismutase

  from 10 minutes before induction to 1 h after the surgery

• Glutathione

  from 10 minutes before induction to 1 h after the surgery

• Xanthine oxidase

  from 10 minutes before induction to 1 h after the surgery

Study Arms (2)

Group E

EXPERIMENTAL

Etomidate was used in both induction and maintenance of anesthesia.

Drug: midazolam; Drug: Penehyclidine Hydrochloride Injection; Drug: Etomidate; Drug: Fentanyl; Drug: Cisatracurium Besilate; Drug: Remifentanil; Drug: Sevoflurane

Group P

ACTIVE COMPARATOR

Propofol was used in both induction and maintenance of anesthesia.

Drug: midazolam; Drug: Propofol; Drug: Fentanyl; Drug: Cisatracurium Besilate; Drug: Remifentanil; Drug: Sevoflurane

Interventions

midazolam DRUG

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

Also known as: Li Yue Xi

Group E; Group P

Penehyclidine Hydrochloride Injection DRUG

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

Also known as: Chang Tuo Ning

Group E

Etomidate DRUG

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

Also known as: Fu Er Li

Group E

Propofol DRUG

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

Group P

Fentanyl DRUG

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

Group E; Group P

Cisatracurium Besilate 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.

Group E; Group P

Remifentanil DRUG

Remifentanil will be injected continuously during maintenance of anesthesia.

Group E; Group P

Sevoflurane DRUG

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

Group E; Group P

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

MeSH Terms

Interventions

Midazolam; Etomidate; Propofol; Fentanyl; cisatracurium; Remifentanil; Sevoflurane

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Propionates; Acids, Acyclic; Carboxylic Acids; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 28, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 28, 2014

Record last verified: 2014-07