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

NCT04837170 | Unknown Phase 4

• 1 other identifier: SAFE-SK-A
• Study Type: interventional
• Target: 12,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postoperative Pain; Adults; Anesthesia

Keywords

S-ketamine,Esketamine,S (+) - ketamine; Acute Pain; Depression, Anxiety; Delirium; Hyperalgesia

Outcome Measures

Primary Outcomes (2)

• 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

• Opioid consumption

  Total opioid consumption(conversion to equivalent morphine)

  Hour 0-48 after surgery

Secondary Outcomes (11)

• NRS pain scores

  Hour 0-48 after surgery

• Time of first rescue analgesia

  Hour 0-48 after surgery

• The incidence of rescue analgesia

  Hour 0-48 after surgery

• Recovery time

  Day 0

• The incidence of unexpected intraoperative events

  Intraoperative

Study Arms (2)

S (+)-Ketamine group

EXPERIMENTAL

Drug: Conventional therapy + S (+)-Ketamine In principle, there are no specific restrictions on the dosage, mode of administration, timing, and compatibility of S-ketamine hydrochloride injection,but the recommended dosage is given, which is lower than the dosage specified in the instructions. Recommended use and dosage of S (+)-Ketamine: 1. Bolus intravenous injection before skin incision, the dose is 0.1\~0.5 mg/kg; 2. Bolus intravenous injection (dose 0.1\~0.5 mg/kg) before skin incision +continuous intravenous infusion (dose of 0.1\~0.25 mg/kg/h) during operation; 3. Continuous intravenous infusion after surgery with a dose of 0.02\~0.1 mg/kg/h for 24\~48 h.

Drug: Conventional therapy + S (+)-Ketamine

Control group

ACTIVE COMPARATOR

Drug: 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.

Drug: Conventional therapy

Interventions

Conventional therapy + S (+)-Ketamine DRUG

Patients who undergo general anesthesia using S(+)-ketamine hydrochloride for anesthesia induction,maintenance or postoperative analgesia.

Also known as: Conventional therapy + S-ketamine, Conventional therapy + Esketamine

S (+)-Ketamine group

Conventional therapy DRUG

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.

Also known as: Routine treatment

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥18 years old;
• \. 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;
• \. ASA score Ⅰ～Ⅲ;
• \. The informed consent form was signed by the patients.

You may not qualify if:

• \. The expected length of hospital stay of the patient is less than 48h;
• \. Patients expected to be admitted to the ICU after surgery;
• \. Patients expected to return to the ward with tracheal catheter after surgery;
• \. Be allergic to S (+) - ketamine;
• \. Patients with severe disorder of consciousness or mental system diseases (schizophrenia, mania, bipolar disorder, psychosis, etc.) or cognitive dysfunction;
• \. Patients with a history of severe cardiovascular disease (congestive heart failure, severe angina attack, or unstable angina or myocardial infarction within 6 months);
• \. Patients during pregnancy or lactation;
• \. Patients with MMSE score \<18 points;
• \. Patients with any of the following contraindications of S (+) - ketamine:
• Patients with risk of serious rise of blood pressure or intracranial pressure;
• Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma;
• Patients with poorly controlled or untreated hypertension (Resting systolic blood pressure greater than 180 mmHg, or resting diastolic blood pressure greater than 100mmHg);
• Patients with untreated or undertreated hyperthyroidism.

Sponsors & Collaborators

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

Related Publications (1)

• Wang H, Duan CY, Huang WQ, Zhao P, Zhou LZ, Liu YH, Liu CM, Chu HC, Wang Q, Diao YG, Hua Z, Meng QT, Li H, Zhang XY, Mi WD, Chen PY. Perioperative intravenous S(+)-ketamine for acute postoperative pain in adults: study protocol for a multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A trial). BMJ Open. 2021 Dec 16;11(12):e054681. doi: 10.1136/bmjopen-2021-054681.

  PMID: 34916327 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Depression; Anxiety Disorders; Delirium; Hyperalgesia

Interventions

Ketamine; Esketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders; Somatosensory Disorders; Sensation Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Weidong Mi, MD

  Chinese PLA General Hospital

  STUDY CHAIR

Central Study Contacts

Weidong Mi, MD

CONTACT

8613381082966; wwdd1962@aliyun.com

Hong Wang, MD

CONTACT

8613661363231; 301wh@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Anesthesiology, Chinese PLA General Hospital

Model Details: Experimental group : Control group=2:1

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: May 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 30, 2022
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share