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

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.

Study Overview

• Status: Completed
• Conditions: Total Hip Arthroplasty
• Intervention / Treatment: Drug: esketamine sub-anesthetic,; Drug: esketamine sub-anesthetic; Drug: esketamine sub-anesthetic

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Changzhou, Jiangsu, China, 213000
      • ChangzhouTCMH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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; Drug: esketamine sub-anesthetic; general anesthesia was performed with esketamine subanesthetic dose.
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; Esketamine subanesthetic dose combined with lumbar plexus block was used; Drug: esketamine sub-anesthetic; general anesthesia was performed with esketamine subanesthetic dose.

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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Psychotropic Drugs; Antidepressive Agents; Anesthetics; Esketamine
• Other Study ID Numbers: ChangzhouTCMH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No