Analysis of Clinical Effect of Subanesthetic Dose of Esketamine Combined With Hip Capsule Peripheral Nerve Block in Elderly Patients Undergoing Total Hip Arthroplasty

Study Overview
=================
Brief 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 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.

Official Title
-----------------
Traditional Chinese Medicine Hospital of Changzhou Affiliated to Nanjing University of Traditional Chinese Medicine

Conditions
-----------------
Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Drug: esketamine sub-anesthetic,
* Drug: esketamine sub-anesthetic
* Drug: esketamine sub-anesthetic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: Allergic to ketamine Abnormal coagulation function Mental system diseases or cognitive dysfunction Severe liver and kidney dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The observation group A<br>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. | Drug: esketamine sub-anesthetic,<br>* the use of esketamine sub-anesthetic dose combined with hip capsule peripheral nerve block<br>|
| Active Comparator: the control group B<br>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. | Drug: esketamine sub-anesthetic<br>* Esketamine subanesthetic dose combined with lumbar plexus block was used<br>|
| Active Comparator: the control group C<br>general anesthesia was performed with esketamine subanesthetic dose. The same maintenance and postoperative analgesia measures were used as in group A. | Drug: esketamine sub-anesthetic<br>* general anesthesia was performed with esketamine subanesthetic dose.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthesia indicators | Add a onset time of anesthesia Outcome Measure | onset time of anesthesia 5 minutes | 
| Anesthesia indicators | Add a duration of block Outcome Measure | duration of block time 350 minutes | 
| Anesthesia indicators | Add a postoperative recovery time Outcome Measure | postoperative recovery time 15 minutes | 
| Anesthesia indicators | Add a postoperative extubation time Outcome Measure | postoperative extubation time 17 minutes | 
| Vital signs | mean arterial pressure before anesthesia (T0) | before anesthesia (T0) | 
| Vital signs | mean arterial pressure during skin incision (T1) | during skin incision (T1) | 
| Vital signs | mean arterial pressure 30 minutes after the start of surgery (T2) | 30 minutes after the start of surgery (T2) | 
| Vital signs | mean arterial pressure at the end of surgery (T3) | at the end of surgery (T3) 85 minutes | 
| Vital signs | heart rate before anesthesia (T0) | before anesthesia (T0) | 
| Vital signs | heart rate 30 minutes during skin incision (T1) | during skin incision (T1) | 
| Vital signs | heart rate after the start of surgery (T2) | after the start of surgery (T2) | 
| Vital signs | heart rate at the end of surgery (T3) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 24hour | 
| Adverse reactions | the incidence of postoperative delirium, nausea and vomiting, drowsiness, skin itching and other adverse reactions | at the end of surgery 48 hours |