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

Anesthesia Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02202239
• Other study ID #: 20140723
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 24, 2014
• Last updated: July 24, 2014
• Start date: September 2014
• Est. completion date: August 2015

Study information

• Verified date: July 2014
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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: ? or ?;

• 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia
• Hemodynamics
• Oxidative Stress

Intervention

Drug:
• midazolam
Before induction, midazolam 0.05mg/kg will be injected intravenously.
• Penehyclidine Hydrochloride Injection
Penehyclidine Hydrochloride 0.01mg/kg will be injected intravenously after midazolam is injected.
• Etomidate
Induction dose: 0.3 mg/kg. Maintenance dose: 10 µg•kg-1•min-1.
• Propofol
Induction dose: 2.0 mg/kg. Maintenance dose: 4 to 6 mg/kg/h.
• Fentanyl
During induction, after injection of etomidate, fentanyl 3 µg/kg will be given intravenously.
• 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.
• Remifentanil
Remifentanil will be injected continuously during maintenance of anesthesia.
• Sevoflurane
Sevoflurane of 1% to 2% will be administered via inhalation to keep bispectral index(BIS) between 50 to 55.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes