Esketamine vs. Ketorolac for Prevention of Postoperative Pain and Cognitive Dysfunction After Total Knee Arthroplasty

NCT05132595 | Unknown DMC

• 1 other identifier: GWang020
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To compare esketamine and ketorolac separately and in combination to prevent postoperative pain and cognitive dysfunction after total knee arthroplasty

Conditions

Postoperative Pain; Postoperative Cognitive Dysfunction; Total Knee Arthroplasty

Keywords

esketamine; ketorolac

Outcome Measures

Primary Outcomes (1)

• Cumulative opioid Consumption

  Each patient was administered analgesics using a PCA (Patient-controlled analgesia) pump containing sufentanil in normal saline after leaving PACU (Postanesthesia care unit). Sufentanyl cumulative consumption is recorded 72 hours postoperatively

  72 hours after surgery

Secondary Outcomes (15)

• Pain Score (NRS) after movement

  72 hours after surgery

• Time of First Postoperative Analgesic Requirement

  1 hour after surgery

• Total Dose of First Postoperative Analgesic Requirement

  1 hour after surgery

• Mini-Mental State Examination (MMSE)

  72 hours after surgery

• The incidence of Side Effects

  72 hours after surgery

Study Arms (4)

Normal saline in patients

PLACEBO COMPARATOR

After the induction of anesthesia, normal saline is intravenously injected in a volume of 2ml, and then a continuous infusion of 20 ml/h normal saline until starting skin suture.

Drug: Normal saline

Esketamine in patients

ACTIVE COMPARATOR

After the induction of anesthesia, esketamine is intravenously injected at 0.4mg/kg, and then a continuous infusion of 0.4mg/kg/h esketamine until starting skin suture.

Drug: Esketamine at high dose

Ketorolac in patients

ACTIVE COMPARATOR

After the induction of anesthesia, ketorolac is intravenously injected at 0.4mg/kg, and then a continuous infusion of 0.4mg/kg/h ketorolac until starting skin suture.

Drug: Ketorolac at high dose

Esketamine and Ketorolac in patients

ACTIVE COMPARATOR

After the induction of anesthesia, 0.2mg/kg esketamine and 0.2mg/kg ketorolac are intravenously injected, and then a continuous infusion of 0.2mg/kg/h esketamine and 0.2mg/kg/h ketorolac until starting skin suture.

Drug: Esketamine at low dose; Drug: Ketorolac at low dose

Interventions

Normal saline DRUG

After the induction of anesthesia, normal saline is intravenously injected in a volume of 2ml, and then a continuous infusion of 20ml/h normal saline until starting skin suture.

Also known as: 0. 9% Sodium Chloride Injection

Normal saline in patients

Esketamine at high dose DRUG

After the induction of anesthesia, esketamine is intravenously injected at 0.4mg/kg, and then a continuous infusion of 0.4mg/kg/h esketamine until starting skin suture.

Also known as: Esketamine Hydrochloride Injection

Esketamine in patients

Esketamine at low dose DRUG

After the induction of anesthesia, esketamine is intravenously injected at 0.2mg/kg, and then a continuous infusion of 0.2mg/kg/h esketamine until starting skin suture.

Also known as: Esketamine Hydrochloride Injection

Esketamine and Ketorolac in patients

Ketorolac at high dose DRUG

After the induction of anesthesia, Ketorolac is intravenously injected at 0.4mg/kg, and then a continuous infusion of 0.4mg/kg/h Ketorolac until starting skin suture.

Also known as: Ketorolac Tromethamine

Ketorolac in patients

Ketorolac at low dose DRUG

After the induction of anesthesia, Ketorolac is intravenously injected at 0.2mg/kg, and then a continuous infusion of 0.2mg/kg/h Ketorolac until starting skin suture.

Also known as: Ketorolac Tromethamine

Esketamine and Ketorolac in patients

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Subject is scheduled to undergo total knee arthroplasty under a short general anesthesia of less than 2 hours
• Subject's American Society of Anesthesiologists physical status is I-II.
• The subject's parent/legally authorized guardian has given written informed consent to participate.

You may not qualify if:

• Subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure.
• Subject has a diagnosis of Insulin dependent diabetes.
• Subject is allergy and contraindication to esketamine or ketorolac.
• Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre- existing therapy with opioids.
• Subject has any contraindication for the use of patient-controlled analgesia (PCA).
• Subject is pregnant or breast-feeding.
• Subject is obese (body mass index \>30kg/m\^2).
• Subject is incapacity to comprehend pain assessment and cognitive assessment.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, 300052, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Cognitive Complications

Interventions

Saline Solution; Sodium Chloride; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Guolin Wang

  Tianjin Medical University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guolin Wang, MD

CONTACT

+8615822855556; wangguolinghad@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 24, 2021
• Study Start: November 30, 2021
• Primary Completion: July 15, 2022
• Study Completion: July 30, 2022
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)