AnesthesiaTKRDM2013NCT01871012
The Assessment of Postoperative Recovery in Elder Diabetic Patients
An observational study of Anesthesia and Knee Osteoarthritis, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Total Knee Replacement (TKR) performed under general anesthesia is a common successful orthopedic procedure. Nonetheless, in elder patients with diabetes mellitus (DM) this procedure can present unique challenges to orthopedic surgeon and anesthesiologist alike. Read more about this study
- Who is it for?
- Ages 65 to 90 years, women only
- Conditions the study is for
- Anesthesia, Knee Osteoarthritis
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Jun 2015
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- Women only
- No healthy volunteers
- Older adult
Study population: All the participants are more than 65 years with knee osteoarthritis, who will undergo selective total uniknee replacement.Participants(n=150)in diabetes mellitus(DM)group have been diagnosed DM more than three years without severe nervous system complications.participants(n=150)in non diabetes mellitus (NDM)haven't been diagnosed diabetes mellitus.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100853
Zhang Hong, M.D,Ph.D, 0086-10-66937462, mazuimao301@yahoo.com.cn
Yuan Weixiu, M.D,Ph.D, yuanweixiu301@126.com
About this study
Official title: The Assessment of the Management of Intraoperation and Postoperative Quality of Recovery for Total Knee Replacement in Elder Diabetic Patients
Total Knee Replacement (TKR) performed under general anesthesia is a common successful orthopedic procedure. Nonetheless, in elder patients with diabetes mellitus (DM) this procedure can present unique challenges to orthopedic surgeon and anesthesiologist alike. Many diabetic patients have clinical or subclinical neuropathy. Although there is no evidence that the neuropathy is exacerbated by neural blockade, recent studies have suggested that the peripheral nerves in diabetic patients may be more susceptible to trauma and local anaesthetic toxicity. Therefore, The investigators observe peripheral nerve blocks with ropivacaine on diabetic patients or non-diabetic patients undergoing TKR by assessing the management of intraoperation and the Postoperative Recovery and complications.
Read the 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.
- Conditions
- Anesthesia, Knee Osteoarthritis
- Keywords
- Nerve Block, Intraoperative Care, Postoperative Recovery and Complications, Stress and Inflammation
- Medical subject headings
- Osteoarthritis, Knee, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
the management of intraoperation
Measured: the time during anesthesia and intraoperation
Secondary outcomes (2)
Postoperative recovery by the Post-operative Quality Recovery Scale (PQRS)
Measured: 7 days postoperatively
Stress and inflammation
Measured: 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junle Liu, Chinese PLA General Hospital
- Investigators
- Zhang Hong, M.D,Ph.D, Study chair, Professor and Director, Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01871012
- Sponsor's protocol ID
- TKRPLA2013
- Acronym
- TKRDM2013
- Status last verified
- Oct 2013
- First submitted
- 4 Jun 2013
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lu B, Jin J, Pei S, Gong M, Liu J. Anesthesia via peripheral nerve blocks during total knee replacement has no effect on postoperative inflammation in elderly patients. J Orthop Surg (Hong Kong). 2023 Sep-Dec;31(3):10225536231217539. doi: 10.1177/10225536231217539.
PubMed 38037804Liu J, Yuan W, Wang X, Royse CF, Gong M, Zhao Y, Zhang H. Peripheral nerve blocks versus general anesthesia for total knee replacement in elderly patients on the postoperative quality of recovery. Clin Interv Aging. 2014 Feb 18;9:341-50. doi: 10.2147/CIA.S56116. eCollection 2014.
PubMed 24600214
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of the Management of Intraoperation and Postoperative Quality of Recovery for Total Knee Replacement in Elder Diabetic Patients
- ClinicalTrials.gov ID
- NCT01871012
- Acronym / sponsor ID
- TKRDM2013 / TKRPLA2013
- Conditions
- Anesthesia, Knee Osteoarthritis
- Keywords
- Nerve Block, Intraoperative Care, Postoperative Recovery and Complications, Stress and Inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total Knee Replacement (TKR) performed under general anesthesia is a common successful orthopedic procedure. Nonetheless, in elder patients with diabetes mellitus (DM) this procedure can present unique challenges to orthopedic surgeon and anesthesiologist alike. Many diabetic patients have clinical or subclinical neuropathy. Although there is no evidence that the neuropathy is exacerbated by neural blockade, recent studies have suggested that the peripheral nerves in diabetic patients may be more susceptible to trauma and local anaesthetic toxicity. Therefore, The investigators observe peripheral nerve blocks with ropivacaine on diabetic patients or non-diabetic patients undergoing TKR by assessing the management of intraoperation and the Postoperative Recovery and complications.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All the participants are more than 65 years with knee osteoarthritis, who will undergo selective total uniknee replacement.Participants(n=150)in diabetes mellitus(DM)group have been diagnosed DM more than three years without severe nervous system complications.participants(n=150)in non diabetes mellitus (NDM)haven't been diagnosed diabetes mellitus.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the management of intraoperation
Time frame: the time during anesthesia and intraoperation
2 secondary outcomes
Postoperative recovery by the Post-operative Quality Recovery Scale (PQRS)
Time frame: 7 days postoperatively
Stress and inflammation
Time frame: 7 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
- Derived from this study: PubMed 38037804Lu B, Jin J, Pei S, Gong M, Liu J. Anesthesia via peripheral nerve blocks during total knee replacement has no effect on postoperative inflammation in elderly patients. J Orthop Surg (Hong Kong). 2023 Sep-Dec;31(3):10225536231217539. doi: 10.1177/10225536231217539.
- Derived from this study: PubMed 24600214Liu J, Yuan W, Wang X, Royse CF, Gong M, Zhao Y, Zhang H. Peripheral nerve blocks versus general anesthesia for total knee replacement in elderly patients on the postoperative quality of recovery. Clin Interv Aging. 2014 Feb 18;9:341-50. doi: 10.2147/CIA.S56116. eCollection 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang Hong, M.D,Ph.D study chair
Professor and Director, Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Knee Osteoarthritis, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Hong, M.D,Ph.D (0086-10-66937462, mazuimao301@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the management of intraoperation (time frame: the time during anesthesia and intraoperation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01871012, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2013.