Effect of Induction and Maintenance of Anesthesia With Etomidate on Hemodynamics and Oxidative Stress in Diabetic Patients
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02202239 |
|
Recruitment Status : Unknown
Verified July 2014 by Zhujiang Hospital.
Recruitment status was: Not yet recruiting
First Posted : July 28, 2014
Last Update Posted : July 28, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hemodynamics Oxidative Stress Anesthesia | Drug: midazolam Drug: Penehyclidine Hydrochloride Injection Drug: Etomidate Drug: Propofol Drug: Fentanyl Drug: Cisatracurium Besilate Drug: Remifentanil Drug: Sevoflurane | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Study Start Date : | September 2014 |
| Estimated Primary Completion Date : | August 2015 |
| Estimated Study Completion Date : | August 2015 |
| 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 Name: Li Yue Xi Drug: Penehyclidine Hydrochloride Injection Penehyclidine Hydrochloride 0.01mg/kg will be injected intravenously after midazolam is injected.
Other Name: Chang Tuo Ning Drug: Etomidate Induction dose: 0.3 mg/kg. Maintenance dose: 10 μg•kg-1•min-1.
Other Name: 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 Name: Li Yue Xi Drug: Propofol Induction dose: 2.0 mg/kg. Maintenance dose: 4 to 6 mg/kg/h. 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. |
- Mean arterial pressure [ Time Frame: from 10 minutes before induction to 1 h after the surgery ]
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.
- Central venous pressure [ Time Frame: from 10 minutes before induction to 1 h after the surgery ]
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.
- Heart rate [ Time Frame: from 10 minutes before induction to 1 h after the surgery ]
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.
- Respiratory rate [ Time Frame: from 10 minutes before induction to 1 h after the surgery ]
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.
- Oxygen saturation [ Time Frame: from 10 minutes before induction to 1 h after the surgery ]
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.
- Blood glucose [ Time Frame: from 10 minutes before induction to 1 h after the surgery ]
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.
- Insulin [ Time Frame: from 10 minutes before induction to 1 h after the surgery ]
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.
- Super oxide dismutase [ Time Frame: from 10 minutes before induction to 1 h after the surgery ]
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.
- Glutathione [ Time Frame: from 10 minutes before induction to 1 h after the surgery ]
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.
- Xanthine oxidase [ Time Frame: from 10 minutes before induction to 1 h after the surgery ]
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
| Responsible Party: | Zhujiang Hospital |
| ClinicalTrials.gov Identifier: | NCT02202239 |
| Other Study ID Numbers: |
20140723 |
| First Posted: | July 28, 2014 Key Record Dates |
| Last Update Posted: | July 28, 2014 |
| Last Verified: | July 2014 |
|
Fentanyl Midazolam Remifentanil Propofol Etomidate Sevoflurane Cisatracurium Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid Narcotics |
Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Anesthetics, Inhalation Neuromuscular Blocking Agents Neuromuscular Agents |