Clinical trial NCT05602428: Analysis of Clinical Effect of Subanesthetic Dose of Esketamine Combined With Hip Capsule Peripheral Nerve Block in Elderly Patients Undergoing Total Hip Arthroplasty
Official title: Traditional Chinese Medicine Hospital of Changzhou Affiliated to Nanjing University of Traditional Chinese Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Arthroplasty
Lead sponsor: Changzhou Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Anesthesia indicators
timeFrame: onset time of anesthesia 5 minutes
measure: Anesthesia indicators
timeFrame: duration of block time 350 minutes
measure: Anesthesia indicators
timeFrame: postoperative recovery time 15 minutes
measure: Anesthesia indicators
timeFrame: postoperative extubation time 17 minutes
measure: Vital signs
timeFrame: before anesthesia (T0)
measure: Vital signs
timeFrame: during skin incision (T1)
measure: Vital signs
timeFrame: 30 minutes after the start of surgery (T2)
measure: Vital signs
timeFrame: at the end of surgery (T3) 85 minutes
measure: Vital signs
timeFrame: before anesthesia (T0)
measure: Vital signs
timeFrame: during skin incision (T1)
measure: Vital signs
timeFrame: after the start of surgery (T2)
measure: Vital signs
timeFrame: at the end of surgery (T3) 78 minutes
measure: Visual Analogue Scale
timeFrame: 0.5hour
measure: Visual Analogue Scale
timeFrame: 2hour
measure: Visual Analogue Scale
timeFrame: 6hour
measure: Visual Analogue Scale
timeFrame: 12hour
measure: Visual Analogue Scale
timeFrame: 24hour
measure: Ramsay sedation score
timeFrame: 0.5hour
measure: Ramsay sedation score
timeFrame: 2hour
measure: Ramsay sedation score
timeFrame: 6hour
measure: Ramsay sedation score
timeFrame: 12hour
measure: Ramsay sedation score
timeFrame: 24hour
measure: Adverse reactions
timeFrame: at the end of surgery 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Changzhou
country: China
facility: ChangzhouTCMH
state: Jiangsu
Study officials:
affiliation: Traditional Chinese Medicine Hospital of Changzhou Affiliated to Nanjing University of Traditional Chinese Medicine
name: Yanhua Huo, BM
role: PRINCIPAL_INVESTIGATOR
References: