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

NCT ID: NCT05602428

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2021-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

esketamine sub-anesthetic,

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

esketamine sub-anesthetic

Intervention Type: DRUG

Esketamine subanesthetic dose combined with lumbar plexus block was used

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.

Group Type: ACTIVE_COMPARATOR

esketamine sub-anesthetic

Intervention Type: DRUG

general anesthesia was performed with esketamine subanesthetic dose.

Interventions

esketamine sub-anesthetic,

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

Intervention Type: DRUG

esketamine sub-anesthetic

Esketamine subanesthetic dose combined with lumbar plexus block was used

Intervention Type: DRUG

esketamine sub-anesthetic

general anesthesia was performed with esketamine subanesthetic dose.

Intervention Type: DRUG

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Yanhua Huo

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanhua Huo, BM

Role: PRINCIPAL_INVESTIGATOR

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

Locations

ChangzhouTCMH

Changzhou, Jiangsu, China

Countries

China

Other Identifiers

ChangzhouTCMH

Identifier Type: -

Identifier Source: org_study_id