Skip to main content
OpenTrials
Completed

NCT Number: NCT05602428

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Total Hip Arthroplasty

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ChangzhouTCMH

Changzhou, Jiangsu, 213000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

esketamine sub-anesthetic,

Drug

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

esketamine sub-anesthetic

Drug

Esketamine subanesthetic dose combined with lumbar plexus block was used

Primary outcomes

  1. Anesthesia indicators

    Time frame: onset time of anesthesia 5 minutes

    Add a onset time of anesthesia Outcome Measure

  2. Anesthesia indicators

    Time frame: duration of block time 350 minutes

    Add a duration of block Outcome Measure

  3. Anesthesia indicators

    Time frame: postoperative recovery time 15 minutes

    Add a postoperative recovery time Outcome Measure

  4. Anesthesia indicators

    Time frame: postoperative extubation time 17 minutes

    Add a postoperative extubation time Outcome Measure

  5. Vital signs

    Time frame: before anesthesia (T0)

    mean arterial pressure before anesthesia (T0)

  6. Vital signs

    Time frame: during skin incision (T1)

    mean arterial pressure during skin incision (T1)

  7. Vital signs

    Time frame: 30 minutes after the start of surgery (T2)

    mean arterial pressure 30 minutes after the start of surgery (T2)

  8. Vital signs

    Time frame: at the end of surgery (T3) 85 minutes

    mean arterial pressure at the end of surgery (T3)

  9. Vital signs

    Time frame: before anesthesia (T0)

    heart rate before anesthesia (T0)

  10. Vital signs

    Time frame: during skin incision (T1)

    heart rate 30 minutes during skin incision (T1)

  11. Vital signs

    Time frame: after the start of surgery (T2)

    heart rate after the start of surgery (T2)

  12. Vital signs

    Time frame: at the end of surgery (T3) 78 minutes

    heart rate at the end of surgery (T3)

  13. Visual Analogue Scale

    Time frame: 0.5hour

    Visual Analogue Scale score (0 is no pain; 0 ~ 4 is mild pain; 4 ~ 7 is moderate pain; 7 ~ 10 is severe pain)

  14. Visual Analogue Scale

    Time frame: 2hour

    Visual Analogue Scale score (0 is no pain; 0 ~ 4 is mild pain; 4 ~ 7 is moderate pain; 7 ~ 10 is severe pain)

  15. Visual Analogue Scale

    Time frame: 6hour

    Visual Analogue Scale score (0 is no pain; 0 ~ 4 is mild pain; 4 ~ 7 is moderate pain; 7 ~ 10 is severe pain)

  16. Visual Analogue Scale

    Time frame: 12hour

    Visual Analogue Scale score (0 is no pain; 0 ~ 4 is mild pain; 4 ~ 7 is moderate pain; 7 ~ 10 is severe pain)

  17. Visual Analogue Scale

    Time frame: 24hour

    Visual Analogue Scale score (0 is no pain; 0 ~ 4 is mild pain; 4 ~ 7 is moderate pain; 7 ~ 10 is severe pain)

  18. Ramsay sedation score

    Time frame: 0.5hour

    Ramsay score (range 0~6 points, 1 point for insufficient sedation, 2~4 points for good sedation, 5~6 points for excessive sedation)

  19. Ramsay sedation score

    Time frame: 2hour

    Ramsay score (range 0~6 points, 1 point for insufficient sedation, 2~4 points for good sedation, 5~6 points for excessive sedation)

  20. Ramsay sedation score

    Time frame: 6hour

    Ramsay score (range 0~6 points, 1 point for insufficient sedation, 2~4 points for good sedation, 5~6 points for excessive sedation)

  21. Ramsay sedation score

    Time frame: 12hour

    Ramsay score (range 0~6 points, 1 point for insufficient sedation, 2~4 points for good sedation, 5~6 points for excessive sedation)

  22. Ramsay sedation score

    Time frame: 24hour

    Ramsay score (range 0~6 points, 1 point for insufficient sedation, 2~4 points for good sedation, 5~6 points for excessive sedation)

  23. Adverse reactions

    Time frame: at the end of surgery 48 hours

    the incidence of postoperative delirium, nausea and vomiting, drowsiness, skin itching and other adverse reactions

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 2, 2022
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.