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

Sponsor

Changzhou Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT05602428

Collaborator

(none)

120

Enrollment

Location

Arms

Actual Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Total Hip Arthroplasty	Drug: esketamine sub-anesthetic, Drug: esketamine sub-anesthetic Drug: esketamine sub-anesthetic	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Traditional Chinese Medicine Hospital of Changzhou Affiliated to Nanjing University of Traditional Chinese Medicine

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

May 31, 2021

Actual Study Completion Date :

May 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: The observation group A 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, the use of esketamine sub-anesthetic dose combined with hip capsule peripheral nerve block
Active Comparator: the control group B 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 Esketamine subanesthetic dose combined with lumbar plexus block was used
Active Comparator: the control group C 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 general anesthesia was performed with esketamine subanesthetic dose.

Arm

Intervention/Treatment

Experimental: The observation group A

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,

the use of esketamine sub-anesthetic dose combined with hip capsule peripheral nerve block

Active Comparator: the control group B

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

Esketamine subanesthetic dose combined with lumbar plexus block was used

Active Comparator: the control group C

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

general anesthesia was performed with esketamine subanesthetic dose.

Outcome Measures

Primary Outcome Measures

Anesthesia indicators [onset time of anesthesia 5 minutes]
Add a onset time of anesthesia Outcome Measure
Anesthesia indicators [duration of block time 350 minutes]
Add a duration of block Outcome Measure
Anesthesia indicators [postoperative recovery time 15 minutes]
Add a postoperative recovery time Outcome Measure
Anesthesia indicators [postoperative extubation time 17 minutes]
Add a postoperative extubation time Outcome Measure
Vital signs [before anesthesia (T0)]
mean arterial pressure before anesthesia (T0)
Vital signs [during skin incision (T1)]
mean arterial pressure during skin incision (T1)
Vital signs [30 minutes after the start of surgery (T2)]
mean arterial pressure 30 minutes after the start of surgery (T2)
Vital signs [at the end of surgery (T3) 85 minutes]
mean arterial pressure at the end of surgery (T3)
Vital signs [before anesthesia (T0)]
heart rate before anesthesia (T0)
Vital signs [during skin incision (T1)]
heart rate 30 minutes during skin incision (T1)
Vital signs [after the start of surgery (T2)]
heart rate after the start of surgery (T2)
Vital signs [at the end of surgery (T3) 78 minutes]
heart rate at the end of surgery (T3)
Visual Analogue Scale [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [at the end of surgery 48 hours]
the incidence of postoperative delirium, nausea and vomiting, drowsiness, skin itching and other adverse reactions

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ChangzhouTCMH	Changzhou	Jiangsu	China	213000

Sponsors and Collaborators

Changzhou Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine

Investigators

Principal Investigator: Yanhua Huo, BM, Traditional Chinese Medicine Hospital of Changzhou Affiliated to Nanjing University of Traditional Chinese Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yanhua Huo, Doctor, Changzhou Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine

ClinicalTrials.gov Identifier:

NCT05602428

Other Study ID Numbers:

ChangzhouTCMH

First Posted:

Nov 2, 2022

Last Update Posted:

Nov 2, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anesthetics

Esketamine

Study Results

No Results Posted as of Nov 2, 2022