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

Not Applicable

Completed

• Conditions: Total Hip Arthroplasty
• Interventions: Drug: esketamine sub-anesthetic; Drug: esketamine sub-anesthetic,

• Registration Number: NCT05602428
• Lead Sponsor: Changzhou Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Study First Submitted: 2022-09-20
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-26
• Last Update Submitted: 2022-10-26
• Study First Posted: 2022-11-02
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the control group B	esketamine sub-anesthetic	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.
The observation group A	esketamine sub-anesthetic,	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.
the control group C	esketamine sub-anesthetic	general anesthesia was performed with esketamine subanesthetic dose. The same maintenance and postoperative analgesia measures were used as in group A.

Primary Outcome Measures

Name	Time	Method
Vital signs	at the end of surgery (T3) 78 minutes	heart rate at the end of surgery (T3)
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)
Anesthesia indicators	postoperative extubation time 17 minutes	Add a postoperative extubation time Outcome Measure
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

Trial Locations

Locations (1)

ChangzhouTCMH; 🇨🇳 Changzhou, Jiangsu, China