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

Total Hip Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05602428
• Other study ID #: ChangzhouTCMH
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: October 2022
• Source: Changzhou Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Drug:
• esketamine sub-anesthetic,
the use of esketamine sub-anesthetic dose combined with hip capsule peripheral nerve block
• esketamine sub-anesthetic
Esketamine subanesthetic dose combined with lumbar plexus block was used
• esketamine sub-anesthetic
general anesthesia was performed with esketamine subanesthetic dose.

Locations

Country	Name	City	State
China	ChangzhouTCMH	Changzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Changzhou Traditional Chinese Medicine Hospital Affiliated to Nanjing University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anesthesia indicators	Add a onset time of anesthesia Outcome Measure	onset time of anesthesia 5 minutes
Primary	Anesthesia indicators	Add a duration of block Outcome Measure	duration of block time 350 minutes
Primary	Anesthesia indicators	Add a postoperative recovery time Outcome Measure	postoperative recovery time 15 minutes
Primary	Anesthesia indicators	Add a postoperative extubation time Outcome Measure	postoperative extubation time 17 minutes
Primary	Vital signs	mean arterial pressure before anesthesia (T0)	before anesthesia (T0)
Primary	Vital signs	mean arterial pressure during skin incision (T1)	during skin incision (T1)
Primary	Vital signs	mean arterial pressure 30 minutes after the start of surgery (T2)	30 minutes after the start of surgery (T2)
Primary	Vital signs	mean arterial pressure at the end of surgery (T3)	at the end of surgery (T3) 85 minutes
Primary	Vital signs	heart rate before anesthesia (T0)	before anesthesia (T0)
Primary	Vital signs	heart rate 30 minutes during skin incision (T1)	during skin incision (T1)
Primary	Vital signs	heart rate after the start of surgery (T2)	after the start of surgery (T2)
Primary	Vital signs	heart rate at the end of surgery (T3)	at the end of surgery (T3) 78 minutes
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Adverse reactions	the incidence of postoperative delirium, nausea and vomiting, drowsiness, skin itching and other adverse reactions	at the end of surgery 48 hours