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

NCT05602428 | Completed

• 1 other identifier: ChangzhouTCMH
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (23)

• 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

Study Arms (3)

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.

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.

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.

Drug: esketamine sub-anesthetic

Interventions

esketamine sub-anesthetic DRUG

Esketamine subanesthetic dose combined with lumbar plexus block was used

the control group B

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Allergic to ketamine
• Abnormal coagulation function
• Mental system diseases or cognitive dysfunction
• Severe liver and kidney dysfunction

Sponsors & Collaborators

• Changzhou Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine: lead

Study Sites (1)

ChangzhouTCMH

Changzhou, Jiangsu, 213000, China

Location

Study Officials

• Yanhua Huo, BM

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: November 2, 2022
• Study Start: January 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: November 2, 2022

Record last verified: 2022-10

Locations

CN (1)