The Assessment of Postoperative Recovery in Elder Diabetic Patients (TKRDM2013)
The Assessment of the Management of Intraoperation and Postoperative Quality of Recovery for Total Knee Replacement in Elder Diabetic Patients
Study Overview
Status
Status
Conditions
Conditions
Detailed Description
After standard external monitors, pulse oximeter, electrocardiogram, noninvasive blood pressure, were applied on subject's arrival in the operation room. Subjects had an intravenous line placed in the upper extremity. Patients received midazolam (0.015-0.03 mg.kg-1), sulfentanil (0.10-0.15µg.kg-1) by infusion, in divided doses, before lumbar plexus and sciatic nerve blocking and supplemental 100% oxygen (3 L.min-1) was administered by facemask spontaneously breathing during the procedure. The procedure was performed by two anesthesiologists with extensive experience in nerve block. After sterile preparation and draping, PNBs were administered using a 21-gauge, 100-mm Stimuplex block needle and a nerve stimulator. A posterior approach to lumbar plexus block was performed with patient in the lateral decubitus position and after a quadriceps muscle response had been identified with nerve stimulator settings at 2 HZ frequency and current between 0.3 and 0.5 mA, and 0.2% ropivacaine (25-30 mL) was injected slowly. Sciatic nerve block was performed in the same position after a twitch of hamstrings, soleus, foot, or toes, had been elicited using the similar current, and 0.2% ropivacaine (15-20 mL) was injected slowly.
After nerve blocks finished, a standardized balanced anesthetic technique was provided in both groups. Anesthesia was administered with etomidate (0.1-0.2mg.kg-1) and rocuronium (0.4-0.6 mg.kg-1), and then suitable laryngeal mask airway (LMA) was facilitated with a respiratory rate of 10-12 bpm, an I:E ratio of 1:2 and an FiO2 of 0.6. Tidal volume will be adjusted to an end tidal CO2 of 35-40 mmHg. Maintaining with remifentanil (0.05-0.30 µg.kg-1.min-1), target concentrations of propofol (0.3-2.0 µg.mL-1) and sevoflurane (0.4 MAC). Infusion rates of propofol and remifentanil varied according to clinical judgment and bispectral index (BIS) range between 40 and 60. All procedures were performed by two veteran anesthesiologists.
Every patient shows signs of inadequate anesthesia such as an increase in systolic arterial blood pressure > 20% from baseline or a heart rate greater than 90 in the absence of hypovolemia, sweating, flushing or movement, sulfentanil, 5-10µg, may be administered. Persistent hypertension without signs of inadequate anesthesia will be treated with nicardipine, 0.4 mg IV, every 3 min until return to baseline value. In both groups patients with a heart rate less than 50 bpm not correlated with blood pressure variation will receive atropine 0.3 mg every 3 minutes until heart rate is back to at least 50 bpm. In all patients, from anesthetic induction to end of surgery, a decrease in systolic blood pressure of more than 30% less than baseline values will be treated with ephedrine 6 mg or phenylephrine 100 µg every 3 min until return to baseline value. Propofol will be stopped at completion of skin closure. Intraoperatively, each patient will also receive 2 mg of tropisetron to decrease postoperative nausea.
Postoperative pain was controlled for all patients routinely by intravenous sulfentanil patient-controlled analgesia (PICA) in combination with Parecoxib (40 mg, every 12 h), a selective COX-2 inhibiter. PICA was continued with sulfentanil (0.9µg.h-1) and 0.9 µg sulfentanil bolus with a 8-min lockout time. Oral oxycodone 0.2 mg was administered necessarily.
The doses of all IV drugs and duration of anesthesia and surgery will be recorded. Ephedrine and phenylephrine consumption and the amount of intravascular fluid administration and all the intraoperative drug dose adjustments will be recorded. The esophageal temperature of the patients will be monitored and maintained at 36 ℃using a force-air warming blanket and warmed i.v. fluids. Postoperative Recovery of the PQRS will be measured on presurgery, 15 minute, 40 minute, 1 day, 3day, 7day postoperatively.
Cardiovascular, cerebrovascular and Pulmonary complications (7days postoperation ), C-reacting protein (CRP) measured preoperatively and on 1, 3 and 7 day postoperatively. Erythrocyte Sedimentation Rate (ESR) measured preoperatively and on 1, 3 and 7 day postoperatively, IL-6 measured preoperatively and on 1, 3 and 7 day postoperatively;blood sugar measured preoperatively on 1, 3 and 7 day postoperatively, nervous system complications and charge measured before left hospital.
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Zhang Hong, M.D,Ph.D
- Phone Number: 0086-10-66937462
- Email: mazuimao301@yahoo.com.cn
Study Contact Backup
- Name: Yuan WeiXiu, M.D,Ph.D
- Phone Number: 0086-10-66938059
- Email: yuanweixiu301@126.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100853
- Recruiting
- Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital
-
Contact:
- Zhang Hong, M.D,Ph.D
- Phone Number: 0086-10-66937462
- Email: mazuimao301@yahoo.com.cn
-
Contact:
- Yuan Weixiu, M.D,Ph.D
- Email: yuanweixiu301@126.com
-
Sub-Investigator:
- Gong Maowei, M.D
-
Sub-Investigator:
- Zhao Ying, M.D
-
Sub-Investigator:
- Pan Wei, M.D
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 65 years old;
- Undergoing selective total uni-knee replacement surgery;
- American Society of Anesthesiologists (ASA) physical status I-III;
- Mini-Mental score examination (MMSE) being more than 23;
- Diagnosis of Type 2 diabetes > 3 years or No diabetes.
Exclusion Criteria:
- Patient refusal to participate in the study;
- Patient refusal of regional block;
- Allergic to local anesthetics or general anesthetics;
- History of opioid dependence;
- Contraindications to nerve blocks (coagulation defects, infection at puncture site, preexisting neurological deficits in the lower extremities);
- Current severe psychiatric disease or alcoholism or drug dependence;
- Severe visual or auditory disorder;
- Severe complications of DM.
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
|---|
|
non-diabetes mellitus group
Subjects undergoing Total Knee Replacement are not diagnosed with diabetes mellitus.
|
|
diabetes mellitus group
subjects have been diagnosed diabetes mellitus mora than three years without serious nerve system complications.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
the management of intraoperation
Time Frame: the time during anesthesia and intraoperation
|
the time during anesthesia and intraoperation
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Postoperative recovery by the Post-operative Quality Recovery Scale (PQRS)
Time Frame: 7 days postoperatively
|
7 days postoperatively
|
|
Stress and inflammation
Time Frame: 7 days postoperatively
|
7 days postoperatively
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
postoperative complications
Time Frame: 7 days postoperatively
|
7 days postoperatively
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Chair: Zhang Hong, M.D,Ph.D, Professor and Director, Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- TKRPLA2013
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