Clinical trial

Analgesic Effects of Low-dose S-ketamine in Patients Undergoing Major Spine Fusion Surgery: A Double-blinded, Randomized Controlled Trial

Name

2021-272

Description

Despite opioid-based multimodal analgesia, moderate-to-severe pain remains a big problem in patients following multi-segment spinal fusion. As a N-methyl-D-aspartate receptor antagonist, S-ketamine has prominent analgesic effects through activating receptors both in the brain and in the spinal cord, inhibiting the excitatory postsynaptic potential, and thus blunting nociception transmission. This randomized controlled trial is designed to investigate whether perioperative S-ketamine infusion can decrease pain intensity after major spine fusion surgery.

Trial arms

Trial start

2022-02-08

Estimated PCD

2024-12-30

Trial end

2024-12-30

Status

Recruiting

Phase

Early phase I

Treatment

S-ketamine

After anesthesia induction, a bolus of 0.15 mg/kg S-ketamine is injected intravenously about 30 min before incision; this is followed by a continuous infusion at a rate of 0.15 mg/kg/h until 1 hour before the end of surgery. After surgery, patient-controlled analgesia is provided. The pump is established with S-ketamine 25 mg, dexmedetomidine 100 microgram, and sufentanil 100 microgram, diluted with normal saline to 100 ml. The pump is programmed to deliver 2-ml boluses with a background infusion rate at 1 ml /h and a 10-min lockout interval.

Arms:

S-ketamine group

Placebo

After anesthesia induction, a bolus of placebo (normal saline) in the same volume is injected intravenously about 30 min before incision; this is followed by a continuous infusion of placebo at the same rate until 1 hour before the end of surgery. After surgery, patient-controlled analgesia is provided. The pump is established with placebo, dexmedetomidine 100 microgram and sufentanil 100 microgram, diluted with normal saline to 100 ml. The pump is programmed to deliver 2-ml boluses with a background infusion rate at 1 ml /h and a 10-min lockout interval.

Arms:

Control group

Size

164

Primary endpoint

The percentage of patients with moderate-to-severe pain in the first 48 hours after surgery.

Up to 48 hours after surgery

Eligibility criteria

Inclusion Criteria: * Patients aged between 18 and 80 years. * Scheduled to undergo multi-segment (≥2) spine fusion surgery. * Agreed to receive postoperative patient-controlled analgesia. Exclusion Criteria: * Refused to participant in this trial. * Poor blood pressure control in those with hypertension (BP \>160/100 mmHg in the ward). * Previous history of hyperthyroidism or pheochromocytoma. * Previous history of schizophrenia, epilepsy or Parkinson disease. * History of sick sinus syndrome, bradycardia (HR \<50 beat per min), or atrioventricular block of grade II or higher without pacemaker. * Severe heart dysfunction (New York Heart Association functional classification 4), hepatic insufficiency (Child-Pugh grade C), renal insufficiency (serum creatinine of 442 μmol/L or above, or requirement of renal replacement therapy), or ASA classification IV or above. * Unable to complete preoperative assessment due to severe dementia or language barrier. * Any other conditions that were considered unsuitable for the study participation.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 164, 'type': 'ESTIMATED'}}

Updated at

2024-05-09

1 organization

1 product

1 drug

3 indications

Organization

Peking University First Hospital

Product

S-ketamine

Indication

S-ketamine

Indication

Postoperative Analgesia

Indication

Spinal Fusion

Drug

Varlilumab