CompletedPhase 4ketamine

Analgesic Effects of Low-dose S-ketamine in Major Spine Fusion Surgery

NCT ID

NCT04964219

Target Enrollment

164 participants

Start Date

2022-02-08

Est. Completion

2025-05-02

About This Study

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.

Conditions Studied

S-ketaminePostoperative AnalgesiaSpine Fusion

Interventions

•S-ketamine
•Placebo

Eligibility

Age:18 Years - 80 Years

Healthy Volunteers:No

View full 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.

Study Locations (1)

Beijing University First Hospital