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

NCT ID: NCT04837170

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 12000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-06-30

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.

Detailed 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.

Conditions

Postoperative Pain; Adults; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S (+)-Ketamine group

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.

Group Type: EXPERIMENTAL

Conventional therapy + S (+)-Ketamine

Intervention Type: DRUG

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

Control group

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.

Group Type: ACTIVE_COMPARATOR

Conventional therapy

Intervention Type: 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.

Interventions

Conventional therapy + S (+)-Ketamine

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Conventional therapy + S-ketamine; Conventional therapy + Esketamine; Routine treatment

Eligibility Criteria

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 Ⅰ～Ⅲ;
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role: collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Shengjing Hospital

OTHER

Sponsor Role: collaborator

Southern Medical University, China

OTHER

Sponsor Role: collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Weidong Mi

Director of the Department of Anesthesiology, Chinese PLA General Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weidong Mi, MD

Role: STUDY_CHAIR

Chinese PLA General Hospital

Central Contacts

Weidong Mi, MD

Role: CONTACT

wwdd1962@aliyun.com

8613381082966

Hong Wang, MD

Role: CONTACT

301wh@163.com

8613661363231

References

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.

Reference Type: DERIVED

PMID: 34916327 (View on PubMed)

Other Identifiers

SAFE-SK-A

Identifier Type: -

Identifier Source: org_study_id