Total Hip ArthroplastyNCT05602428
Analysis of Clinical Effect of Subanesthetic Dose of Esketamine Combined With Hip Capsule Peripheral Nerve Block in Elderly Patients Undergoing Total Hip Arthroplasty
A study testing esketamine sub-anesthetic, and esketamine sub-anesthetic in people with Total Hip Arthroplasty, run by Changzhou Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine at 1 site in China.
Trial summary
To observe the clinical effect of esketamine combined with hip capsule peripheral nerve block in elderly patients undergoing total hip arthroplasty. A total of 120 elderly patients who underwent total hip arthroplasty in our hospital from January 2020 to May 2021 were randomly divided into three groups, 40 cases in… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- esketamine sub-anesthetic, and esketamine sub-anesthetic
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 May 2021
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 60 years
- American Society of Anesthesiology (ASA) II or III
- No serious coronary heart disease, hypertension, diabetes and related complications, no serious liver and kidney function damage, no mental illness
Who cannot join
- Allergic to ketamine
- Abnormal coagulation function
- Mental system diseases or cognitive dysfunction
- Severe liver and kidney dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Traditional Chinese Medicine Hospital of Changzhou Affiliated to Nanjing University of Traditional Chinese Medicine
To observe the clinical effect of esketamine combined with hip capsule peripheral nerve block in elderly patients undergoing total hip arthroplasty. A total of 120 elderly patients who underwent total hip arthroplasty in our hospital from January 2020 to May 2021 were randomly divided into three groups, 40 cases in each group. The observation group A was treated with esketamine subanesthetic dose combined with hip capsule peripheral nerve block, the control group B was treated with esketamine subanesthetic dose combined with lumbar plexus block, and the control group C was treated with esketamine subanesthetic dose for general anesthesia. The onset time of anesthesia, duration of block, postoperative recovery time, postoperative extubation time, MAP and HR indexes before anesthesia (T0), during skin incision (T1), 30 minutes after the start of surgery (T2), and at the end of surgery (T3) were recorded in the three groups, and the VAS score and Ramsay score at 0.5 h, 2 h, 6 h, 12 h, and 24 h after surgery, as well as the incidence of postoperative adverse reactions were recorded in the three groups.
- Conditions
- Total Hip Arthroplasty
- Being tested
- esketamine sub-anesthetic,, esketamine sub-anesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esketamine sub-anesthetic,Drug
the use of esketamine sub-anesthetic dose combined with hip capsule peripheral nerve block
esketamine sub-anestheticDrug
Esketamine subanesthetic dose combined with lumbar plexus block was used
esketamine sub-anestheticDrug
general anesthesia was performed with esketamine subanesthetic dose.
| Study group | Role | What they receive |
|---|---|---|
| The observation group A | Experimental | The use of esketamine sub-anesthetic dose combined with hip capsule peripheral nerve block. The patients were subjected to local anesthesia and punctured through the left radial artery for invasive arterial blood pressure monitoring. Anesthesia induction: the observation group followed by intravenous injection of ketamine 0.2mg/kg, sufentanil 0.3μg/kg, Cyclophenol 0.3mg/kg, midazolam 2mg, rocuronium 0.6mg/kg. After the onset of the drug endotracheal intubation, connect anesthesia machine control breathing. Anesthesia was maintained with 1%~2% sevoflurane inhalation, remifentanil infusion rate was 0.2~0.3 μg/kg·min, sevoflurane was stopped 30 min before the end of the operation. Patient-controlled intravenous analgesia pump (PCIA) was given for postoperative analgesia. PCIA formula: sufentanil 100ug+ondansetron 8mg+ketorolac tromethamine 60mg+saline to 100ml, pump speed 2ml/h, automatic single dose 3ml, lock time 20min. Receives: Drug: esketamine sub-anesthetic, |
| the control group B | Active comparator | Esketamine subanesthetic dose combined with lumbar plexus block was used. The patient was placed in the healthy lateral decubitus position and ultrasound-guided puncture was performed 4 cm beside the 3rd and 4th lumbar vertebrae (Figure 1B、C). The frequency of the ultrasound probe was 2-5 MHz, and the probe was adjusted until the images below the transverse processes of the 3rd to 5th lumbar vertebrae and the psoas muscle were clearly displayed, and the needle was inserted close to the probe and retracted in the lumbar plexus, and sufentanil 0.5 μg/kg, propofol 1.5 mg/kg, and rocuronium 0.6 mg/kg were injected after no blood extraction. General anesthesia was then performed using a subanesthetic dose of esketamine and the same maintenance and postoperative analgesic measures were used as in group A. Receives: Drug: esketamine sub-anesthetic |
| the control group C | Active comparator | general anesthesia was performed with esketamine subanesthetic dose. The same maintenance and postoperative analgesia measures were used as in group A. Receives: Drug: esketamine sub-anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesia indicators
Add a onset time of anesthesia Outcome Measure
Measured: onset time of anesthesia 5 minutes
Anesthesia indicators
Add a duration of block Outcome Measure
Measured: duration of block time 350 minutes
Anesthesia indicators
Add a postoperative recovery time Outcome Measure
Measured: postoperative recovery time 15 minutes
Anesthesia indicators
Add a postoperative extubation time Outcome Measure
Measured: postoperative extubation time 17 minutes
Vital signs
mean arterial pressure before anesthesia (T0)
Measured: before anesthesia (T0)
Vital signs
mean arterial pressure during skin incision (T1)
Measured: during skin incision (T1)
Vital signs
mean arterial pressure 30 minutes after the start of surgery (T2)
Measured: 30 minutes after the start of surgery (T2)
Vital signs
mean arterial pressure at the end of surgery (T3)
Measured: at the end of surgery (T3) 85 minutes
Vital signs
heart rate before anesthesia (T0)
Measured: before anesthesia (T0)
Vital signs
heart rate 30 minutes during skin incision (T1)
Measured: during skin incision (T1)
Vital signs
heart rate after the start of surgery (T2)
Measured: after the start of surgery (T2)
Vital signs
heart rate at the end of surgery (T3)
Measured: at the end of surgery (T3) 78 minutes
Visual Analogue Scale
Visual Analogue Scale score (0 is no pain; 0 ~ 4 is mild pain; 4 ~ 7 is moderate pain; 7 ~ 10 is severe pain)
Measured: 0.5hour
Visual Analogue Scale
Visual Analogue Scale score (0 is no pain; 0 ~ 4 is mild pain; 4 ~ 7 is moderate pain; 7 ~ 10 is severe pain)
Measured: 2hour
Visual Analogue Scale
Visual Analogue Scale score (0 is no pain; 0 ~ 4 is mild pain; 4 ~ 7 is moderate pain; 7 ~ 10 is severe pain)
Measured: 6hour
Visual Analogue Scale
Visual Analogue Scale score (0 is no pain; 0 ~ 4 is mild pain; 4 ~ 7 is moderate pain; 7 ~ 10 is severe pain)
Measured: 12hour
Visual Analogue Scale
Visual Analogue Scale score (0 is no pain; 0 ~ 4 is mild pain; 4 ~ 7 is moderate pain; 7 ~ 10 is severe pain)
Measured: 24hour
Ramsay sedation score
Ramsay score (range 0~6 points, 1 point for insufficient sedation, 2~4 points for good sedation, 5~6 points for excessive sedation)
Measured: 0.5hour
Ramsay sedation score
Ramsay score (range 0~6 points, 1 point for insufficient sedation, 2~4 points for good sedation, 5~6 points for excessive sedation)
Measured: 2hour
Ramsay sedation score
Ramsay score (range 0~6 points, 1 point for insufficient sedation, 2~4 points for good sedation, 5~6 points for excessive sedation)
Measured: 6hour
Ramsay sedation score
Ramsay score (range 0~6 points, 1 point for insufficient sedation, 2~4 points for good sedation, 5~6 points for excessive sedation)
Measured: 12hour
Ramsay sedation score
Ramsay score (range 0~6 points, 1 point for insufficient sedation, 2~4 points for good sedation, 5~6 points for excessive sedation)
Measured: 24hour
Adverse reactions
the incidence of postoperative delirium, nausea and vomiting, drowsiness, skin itching and other adverse reactions
Measured: at the end of surgery 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Jan 2020
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changzhou Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhua Huo, Changzhou Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine
- Investigators
- Yanhua Huo, BM, Principal investigator, Traditional Chinese Medicine Hospital of Changzhou Affiliated to Nanjing University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602428
- Sponsor's protocol ID
- ChangzhouTCMH
- Status last verified
- Oct 2022
- First submitted
- 20 Sep 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Medicine Hospital of Changzhou Affiliated to Nanjing University of Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT05602428
- Acronym / sponsor ID
- ChangzhouTCMH
- Conditions
- Total Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Changzhou Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 2 Nov 2022 (actual)
- 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.
To observe the clinical effect of esketamine combined with hip capsule peripheral nerve block in elderly patients undergoing total hip arthroplasty. A total of 120 elderly patients who underwent total hip arthroplasty in our hospital from January 2020 to May 2021 were randomly divided into three groups, 40 cases in each group. The observation group A was treated with esketamine subanesthetic dose combined with hip capsule peripheral nerve block, the control group B was treated with esketamine subanesthetic dose combined with lumbar plexus block, and the control group C was treated with esketamine subanesthetic dose for general anesthesia. The onset time of anesthesia, duration of block, postoperative recovery time, postoperative extubation time, MAP and HR indexes before anesthesia (T0), during skin incision (T1), 30 minutes after the start of surgery (T2), and at the end of surgery (T3) were recorded in the three groups, and the VAS score and Ramsay score at 0.5 h, 2 h, 6 h, 12 h, and 24 h after surgery, as well as the incidence of postoperative adverse reactions were recorded in the three groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The observation group A | Experimental | Drug: esketamine sub-anesthetic,The use of esketamine sub-anesthetic dose combined with hip capsule peripheral nerve block. The patients were subjected to local anesthesia and punctured through the left radial artery for invasive arterial blood pressure monitoring. Anesthesia induction: the observation group followed by intravenous injection of ketamine 0.2mg/kg, sufentanil 0.3μg/kg, Cyclophenol 0.3mg/kg, midazolam 2mg, rocuronium 0.6mg/kg. After the onset of the drug endotracheal intubation, connect anesthesia machine control breathing. Anesthesia was maintained with 1%~2% sevoflurane inhalation, remifentanil infusion rate was 0.2~0.3 μg/kg·min, sevoflurane was stopped 30 min before the end of the operation. Patient-controlled intravenous analgesia pump (PCIA) was given for postoperative analgesia. PCIA formula: sufentanil 100ug+ondansetron 8mg+ketorolac tromethamine 60mg+saline to 100ml, pump speed 2ml/h, automatic single dose 3ml, lock time 20min. |
| the control group B | Active comparator | Drug: esketamine sub-anestheticEsketamine subanesthetic dose combined with lumbar plexus block was used. The patient was placed in the healthy lateral decubitus position and ultrasound-guided puncture was performed 4 cm beside the 3rd and 4th lumbar vertebrae (Figure 1B、C). The frequency of the ultrasound probe was 2-5 MHz, and the probe was adjusted until the images below the transverse processes of the 3rd to 5th lumbar vertebrae and the psoas muscle were clearly displayed, and the needle was inserted close to the probe and retracted in the lumbar plexus, and sufentanil 0.5 μg/kg, propofol 1.5 mg/kg, and rocuronium 0.6 mg/kg were injected after no blood extraction. General anesthesia was then performed using a subanesthetic dose of esketamine and the same maintenance and postoperative analgesic measures were used as in group A. |
| the control group C | Active comparator | Drug: esketamine sub-anestheticgeneral anesthesia was performed with esketamine subanesthetic dose. The same maintenance and postoperative analgesia measures were used as in group A. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged ≥ 60 years
- American Society of Anesthesiology (ASA) II or III
- No serious coronary heart disease, hypertension, diabetes and related complications, no serious liver and kidney function damage, no mental illness
Key exclusion criteria (4 listed)
- Allergic to ketamine
- Abnormal coagulation function
- Mental system diseases or cognitive dysfunction
- Severe liver and kidney dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| esketamine sub-anesthetic,the use of esketamine sub-anesthetic dose combined with hip capsule peripheral nerve block | Drug | The observation group A |
| esketamine sub-anestheticEsketamine subanesthetic dose combined with lumbar plexus block was used | Drug | the control group B |
| esketamine sub-anestheticgeneral anesthesia was performed with esketamine subanesthetic dose. | Drug | the control group C |
Primary outcome
Anesthesia indicators
Time frame: onset time of anesthesia 5 minutes
Add a onset time of anesthesia Outcome Measure
Anesthesia indicators
Time frame: duration of block time 350 minutes
Add a duration of block Outcome Measure
Anesthesia indicators
Time frame: postoperative recovery time 15 minutes
Add a postoperative recovery time Outcome Measure
Anesthesia indicators
Time frame: postoperative extubation time 17 minutes
Add a postoperative extubation time Outcome Measure
Vital signs
Time frame: before anesthesia (T0)
mean arterial pressure before anesthesia (T0)
Vital signs
Time frame: during skin incision (T1)
mean arterial pressure during skin incision (T1)
Vital signs
Time frame: 30 minutes after the start of surgery (T2)
mean arterial pressure 30 minutes after the start of surgery (T2)
Vital signs
Time frame: at the end of surgery (T3) 85 minutes
mean arterial pressure at the end of surgery (T3)
Vital signs
Time frame: before anesthesia (T0)
heart rate before anesthesia (T0)
Vital signs
Time frame: during skin incision (T1)
heart rate 30 minutes during skin incision (T1)
Vital signs
Time frame: after the start of surgery (T2)
heart rate after the start of surgery (T2)
Vital signs
Time frame: at the end of surgery (T3) 78 minutes
heart rate at the end of surgery (T3)
Visual Analogue Scale
Time frame: 0.5hour
Visual Analogue Scale score (0 is no pain; 0 ~ 4 is mild pain; 4 ~ 7 is moderate pain; 7 ~ 10 is severe pain)
Visual Analogue Scale
Time frame: 2hour
Visual Analogue Scale score (0 is no pain; 0 ~ 4 is mild pain; 4 ~ 7 is moderate pain; 7 ~ 10 is severe pain)
Visual Analogue Scale
Time frame: 6hour
Visual Analogue Scale score (0 is no pain; 0 ~ 4 is mild pain; 4 ~ 7 is moderate pain; 7 ~ 10 is severe pain)
Visual Analogue Scale
Time frame: 12hour
Visual Analogue Scale score (0 is no pain; 0 ~ 4 is mild pain; 4 ~ 7 is moderate pain; 7 ~ 10 is severe pain)
Visual Analogue Scale
Time frame: 24hour
Visual Analogue Scale score (0 is no pain; 0 ~ 4 is mild pain; 4 ~ 7 is moderate pain; 7 ~ 10 is severe pain)
Ramsay sedation score
Time frame: 0.5hour
Ramsay score (range 0~6 points, 1 point for insufficient sedation, 2~4 points for good sedation, 5~6 points for excessive sedation)
Ramsay sedation score
Time frame: 2hour
Ramsay score (range 0~6 points, 1 point for insufficient sedation, 2~4 points for good sedation, 5~6 points for excessive sedation)
Ramsay sedation score
Time frame: 6hour
Ramsay score (range 0~6 points, 1 point for insufficient sedation, 2~4 points for good sedation, 5~6 points for excessive sedation)
Ramsay sedation score
Time frame: 12hour
Ramsay score (range 0~6 points, 1 point for insufficient sedation, 2~4 points for good sedation, 5~6 points for excessive sedation)
Ramsay sedation score
Time frame: 24hour
Ramsay score (range 0~6 points, 1 point for insufficient sedation, 2~4 points for good sedation, 5~6 points for excessive sedation)
Adverse reactions
Time frame: at the end of surgery 48 hours
the incidence of postoperative delirium, nausea and vomiting, drowsiness, skin itching and other adverse reactions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
Yanhua Huo, BM principal investigator
Traditional Chinese Medicine Hospital of Changzhou Affiliated to Nanjing University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing esketamine sub-anesthetic, and esketamine sub-anesthetic in people with Total Hip Arthroplasty, run by Changzhou Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 2 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthesia indicators (time frame: onset time of anesthesia 5 minutes). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2022.