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

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

Study Overview

• Status: Unknown
• Conditions: Oxidative Stress; Anesthesia; Hemodynamics
• Intervention / Treatment: Drug: midazolam; Drug: Penehyclidine Hydrochloride Injection; Drug: Etomidate; Drug: Fentanyl; Drug: Cisatracurium Besilate; Drug: Remifentanil; Drug: Sevoflurane; Drug: Propofol

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group E; Etomidate was used in both induction and maintenance of anesthesia.	Drug: midazolam; Before induction, midazolam 0.05mg/kg will be injected intravenously.; Other Names: Li Yue Xi; Drug: Penehyclidine Hydrochloride Injection; Penehyclidine Hydrochloride 0.01mg/kg will be injected intravenously after midazolam is injected.; Other Names: Chang Tuo Ning; Drug: Etomidate; Induction dose: 0.3 mg/kg. Maintenance dose: 10 μg•kg-1•min-1.; Other Names: Fu Er Li; Drug: Fentanyl; During induction, after injection of etomidate, fentanyl 3 μg/kg will be given intravenously.; 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.; Drug: Remifentanil; Remifentanil will be injected continuously during maintenance of anesthesia.; Drug: Sevoflurane; Sevoflurane of 1% to 2% will be administered via inhalation to keep bispectral index（BIS) between 50 to 55.
Active Comparator: Group P; Propofol was used in both induction and maintenance of anesthesia.	Drug: midazolam; Before induction, midazolam 0.05mg/kg will be injected intravenously.; Other Names: Li Yue Xi; Drug: Fentanyl; During induction, after injection of etomidate, fentanyl 3 μg/kg will be given intravenously.; 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.; Drug: Remifentanil; Remifentanil will be injected continuously during maintenance of anesthesia.; Drug: Sevoflurane; Sevoflurane of 1% to 2% will be administered via inhalation to keep bispectral index（BIS) between 50 to 55.; Drug: Propofol; Induction dose: 2.0 mg/kg. Maintenance dose: 4 to 6 mg/kg/h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Super oxide dismutase	2 ml blood will be collected 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. The blood will be preserved below -20 ℃ before super oxide dismutase was measured. 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
Glutathione	2 ml blood will be collected 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. The blood will be preserved below -20 ℃ before glutathione was measured. 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
Xanthine oxidase	2 ml blood will be collected 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. The blood will be preserved below -20 ℃ before xanthine oxidase dismutase was measured. 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

Collaborators and Investigators

• Sponsor: Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: July 24, 2014
• First Submitted That Met QC Criteria: July 24, 2014
• First Posted (Estimate): July 28, 2014

Study Record Updates

• Last Update Posted (Estimate): July 28, 2014
• Last Update Submitted That Met QC Criteria: July 24, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anesthetics, Inhalation; Neuromuscular Agents; Neuromuscular Blocking Agents; Remifentanil; Fentanyl; Midazolam; Propofol; Sevoflurane; Etomidate; Cisatracurium
• Other Study ID Numbers: 20140723

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No