Low-dose S-ketamine and Dexmedetomidine in Combination With Opioids for Postoperative Analgesia
NCT ID: NCT04791059
Last Updated: 2022-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2021-04-09
2022-10-07
Brief Summary
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Detailed Description
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Ketamine is a noncompetitive N-methyl-D-aspartate receptor antagonist (NMDA) with analgesic and anti-hyperalgesia effects. It is widely used for anesthesia induction in critically ill patients, pediatric anesthesia and postoperative analgesia. The advantages of ketamine include mild influence on respiratory and circulatory function, and good analgesic effect. Recent guidelines recommends the use of low-dose ketamine infusion for postoperative analgesia in patients with moderate to severe pain, in order to reduce the consumption of opioids. S-ketamine is the pure dextrorotatory enantiomer of ketamine with stronger analgesic effect and lower incidence of adverse reactions.
Dexmedetomidine is a highly selective α2 receptor agonist with effects of antianxiety, sedation and analgesia. When used as a supplement, it improves analgesic effect, and reduces opioid consumption and opioid related adverse reactions. In the same time, dexmedetomidine activates the endogenous sleep pathway and improves sleep quality by prolonging total sleep time, increasing sleep efficiency, and promoting subjective sleep quality.
It is worthy to note that ketamine can produce adverse reactions such as agitation, delirium and anxiety, and increase the incidence of hallucinations and nightmares when the given dose is slightly higher; whereas the sedative effect of dexmedetomidine may help to reduce the adverse effects of ketamine. We hypothesize that low-dose ketamine and dexmedetomidine in combination with opioids may have synergistic effects in postoperative analgesia and reduce drug-related adverse reactions.
This study aims to explore the effect of low-dose of S-ketamine and dexmedetomidine in combination with opioids for postoperative patient-controlled intravenous analgesia in patients following scoliosis correction surgery.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Combined analgesia group
Patient-controlled analgesia is established with S-ketamine 50 mg, dexmedetomidine 200 microgram, and sufentanil 4 microgram/kg (maximum 250 microgram), diluted with normal saline to 200 ml, and programmed to administer 2-ml boluses with a lock-out interval of 8 minutes and a background infusion rate at 1 ml/h.
S-ketamine
S-ketamine 50 mg is included in the mixture for patient-controlled analgesia.
Dexmedetomidine
Dexmedetomidine 200 microgram is included in the mixture for patient-controlled analgesia.
Sufentanil
Sufentanil 4 microgram/kg (maximum 250 microgram) is included in the mixture for patient-controlled analgesia.
Control group
Patient-controlled analgesia is established with sufentanil 4 microgram/kg (maximum 250 microgram), diluted with normal saline to 200 ml, and programmed to administer 2-ml boluses with a lock-out interval of 8 minutes and a background infusion rate at 1 ml/h.
Sufentanil
Sufentanil 4 microgram/kg (maximum 250 microgram) is included in the mixture for patient-controlled analgesia.
Interventions
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S-ketamine
S-ketamine 50 mg is included in the mixture for patient-controlled analgesia.
Dexmedetomidine
Dexmedetomidine 200 microgram is included in the mixture for patient-controlled analgesia.
Sufentanil
Sufentanil 4 microgram/kg (maximum 250 microgram) is included in the mixture for patient-controlled analgesia.
Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo scoliosis correction with pedicle screw fixation;
* Planned to use patient-controlled intravenous analgesia after surgery.
Exclusion Criteria
* Preoperative sick sinus syndrome, severe sinus bradycardia (heart rate \< 50 beats/min), atrioventricular block grade II or above without pacemaker; or comorbid with congenital heart disease, arrhythmia, or other serious cardiovascular diseases with a cardiac function grade ≥ III;
* Patients with obstructive sleep apnea syndrome, or a STOP-Bang score ≥ 3 in combination with a serum HCO3- level ≥ 28 mmol/L;
* History of hyperthyroidism and pheochromocytoma;
* History of schizophrenia, epilepsy, myasthenia gravis, or delirium;
* Severe liver dysfunction (child Pugh grade C), severe renal dysfunction (preoperative dialysis), or American Society of Anesthesiologists grade ≥ IV;
* Barrier in communication;
* Other conditions that are considered unsuitable for study participation.
18 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Responsible Party
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Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
Principal Investigators
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Dong-Xin Wang, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Countries
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References
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Other Identifiers
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2020-465
Identifier Type: -
Identifier Source: org_study_id