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

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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
Sponsor:
Information provided by (Responsible Party):
Zhujiang Hospital

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

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

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Etomidate

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.




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.


  6. 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.


  7. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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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
Additional relevant MeSH terms:
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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