Safety and Efficacy Evaluation of S (+) - Ketamine in Adults

Postoperative Pain Clinical Trial

Official title:

Safety and Efficacy Evaluation of S（+）-Ketamine for Postoperative Acute Pain in Adults in Perioperative Settings: A Multicenter, Randomized, Open-label, Active Controlled Pragmatic Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04837170
• Other study ID #: SAFE-SK-A
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2021
• Source: Chinese PLA General Hospital
• Contact: Weidong Mi, MD
• Phone: 8613381082966
• Email: wwdd1962[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multicenter, randomized, open-label, active controlled pragmatic clinical trial that evaluates the safety and efficacy of S (+) -ketamine for postoperative acute pain in adults in perioperative settings.

Description:

Patients often suffer acute pain after operation ，which may affect the recovery. Opioid such as morphine is the most commonly analgesic drugs, but opioid has many obviously adverse reactions ,for example respiratory depression,circulation inhibition,tolerance, addiction, nausea, vomiting, pruritus, etc. S (+) - ketamine has been described to decrease acute pain and opioid consumption,but it needs to confirm for chinese patients undergoing surgery.

Objective:Evaluate the efficacy and safety of S (+) - ketamine on acute perioperative pain for chinese adult patients,and look for the best dosage, mode of administration, timing, and compatibility ,as well explore the effect of S (+) - ketamine on postoperative delirium,anxiety ,depression and cognitive dysfunction.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12000
• Est. completion date: June 30, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. Age =18 years old;

• 2. Scheduled for elective digestive tract surgery, gynecological surgery, urological surgery, thoracic surgery, orthopedic limb surgery, orthopedic spine surgery or body surface surgery (thyroid surgery or breast surgery), head and neck surgery;

• 3. ASA score ?~?;

• 4. The informed consent form was signed by the patients.

Exclusion Criteria:

• 1. The expected length of hospital stay of the patient is less than 48h;

• 2. Patients expected to be admitted to the ICU after surgery;

• 3. Patients expected to return to the ward with tracheal catheter after surgery;

• 4. Be allergic to S (+) - ketamine;

• 5. Patients with severe disorder of consciousness or mental system diseases (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction;

• 6. Patients with a history of severe cardiovascular disease (congestive heart failure, severe angina attack, or unstable angina or myocardial infarction within 6 months);

• 7. Patients during pregnancy or lactation;

• 8. Patients with MMSE score <18 points;

• 9. Patients with any of the following contraindications of S (+) - ketamine:

1. Patients with risk of serious rise of blood pressure or intracranial pressure;

2. Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma;

3. Patients with poorly controlled or untreated hypertension (Resting systolic blood pressure greater than 180 mmHg, or resting diastolic blood pressure greater than 100mmHg);

4. Patients with untreated or undertreated hyperthyroidism.

Related Conditions & MeSH terms

• Adults
• Anesthesia
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Conventional therapy + S (+)-Ketamine
Patients who undergo general anesthesia using S(+)-ketamine hydrochloride for anesthesia induction,maintenance or postoperative analgesia.
• Conventional therapy
Receiving conventional therapy without S (+)-Ketamine hydrochloride injection. There is no restrictions in drugs, doses and incompatibility, the researchers can choose appropriate medication regimens based on clinical practice, but other NMDA receptor antagonists are not be allowed to use, such as dextromethorphan and amantadine.

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Beijing Hospital, First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital, Sun Yat-Sen University, Jiangsu Provincial People's Hospital, Renmin Hospital of Wuhan University, Shengjing Hospital, Southern Medical University, China, The Affiliated Hospital of Qingdao University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The area under the broken line of NRS score	The score of Numerical Rating Scale(NRS) is 0-10, the higher the score, the more severe the pain.	Hour 0-48 after surgery
Primary	Opioid consumption	Total opioid consumption(conversion to equivalent morphine)	Hour 0-48 after surgery
Secondary	NRS pain scores	The score of Numerical Rating Scale(NRS) is 0-10, the higher the score, the more severe the pain.	Hour 0-48 after surgery
Secondary	Time of first rescue analgesia	The time from the end of the operation to the first rescue analgesics after the operation. Rescue analgesia refers to the analgesia according to the patient's requirements in addition to routine postoperative analgesia.	Hour 0-48 after surgery
Secondary	The incidence of rescue analgesia	The incidence of rescue analgesia within 48h after surgery	Hour 0-48 after surgery
Secondary	Recovery time	The time from the end of the operation to recovery(can be awakened)	Day 0
Secondary	The incidence of unexpected intraoperative events	Unexpected events during operation include intraoperative cough, laryngeal spasm, body movement, tachycardia,decreased oxygen saturation, respiratory depression, bradycardia, hypertension and hypotension.	Intraoperative
Secondary	The Patient Efficacy Questionnaire (IPOQ ) scores	Patient Efficacy Questionnaire (IPOQ ) scale include 13 questions , each question's score is 0-10 or 0-100%, it involves postoperative pain, mood and quality of life. The higher the score, the more severe the pain symptoms.	Hour 48 after surgery
Secondary	The incidence of adverse events after surgery	The incidence of adverse events from the end of the operation to 48h after surgery. Including nausea, vomiting, increased secretions, dizziness, oversedation, infection,anesthetic awareness, nightmares, restlessness, pruritus, disorientation, delirium, respiratory depression, diplopia, diarrhea, intestinal obstruction, urinary retention, gastroesophageal reflux, constipation, chills, hallucinations, etc.	Hour 0-48 after surgery
Secondary	Pharmacoeconomic indicators	Calculating incremental cost-effectiveness ratio (ICER)based on cost-effectiveness analysis.	Hour 48 after surgery
Secondary	Incidence of postoperative delirium	The Chinese version of the 3D-CAM scale is used for the diagnosis of delirium, and the assessment will be carried out at 24h, 48h and 72h after the operation. If the patient is discharged 72h after the patient is discharged, it may not be assessed.	Hour 0-48 after surgery
Secondary	Simple Mental State Examination (MMSE) Scale score	The total score of Simple Mental State Examination Scale (MMSE) is 30,the higher the score, the better the cognitive function.	Hour 48 after surgery
Secondary	Hospital Anxiety and Depression (HAD) Scale score	Hospital Anxiety and Depression Scale (HAD) includes anxiety measure(7questions,0-21pionts) and depression measure(7 questions,0-21pionts),the higher the score, the more severe thesymptoms.	Hour 48 after surgery