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NCT03521167
Multimodal Analgesia Versus Traditional Opiate Based Analgesia
NA trial testing Ketamine in Cardiac Surgery in 225 participants. Status unknown.
1 May 2019
Quick facts
| Lead sponsor | Shanghai Zhongshan Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 225 |
| Start date | 1 May 2018 |
| Primary completion | 1 May 2019 |
| Estimated completion | 30 December 2019 |
Drugs / interventions tested
- Ketamine (ketamine) — full drug profile →
- Lidocaine
- Dexmedetomidine (dexmedetomidine) — full drug profile →
- Gabapentin (Gabapentin) — full drug profile →
- Tylenol
- Gabapentin Pill — full drug profile →
- Tylenol Pill
Conditions studied
- Cardiac Surgery — all drugs for Cardiac Surgery →
Sponsor
Shanghai Zhongshan Hospital
Who can join
Adults 18 to 80, any sex, with Cardiac Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Pain after cardiac surgery can be moderate to severe with incisions to the sternum and lower extremities, and also the placement of chest tubes. Postoperative pain may contribute to delirium, stress, myocardial oxygen demand supply imbalance, etc. Traditionally postoperative pain management after cardiac surgery has been based on opiate analgesics. However, opiates have many deleterious side effects including nausea/vomiting, ileus, bladder dysfunction, and respiratory depression, which substantially influence patient recovery and may delay discharge after surgery. The current study is designed to evaluate if an opiate sparing multimodal regimen of tylenol, gabapentin, ketamine, lidocaine and dexmedetomidine provided better analgesic effect (pain score, postoperative PCA opioid dose), less side effects (PONV) and improved cardiac surgery outcome (delirium, a-fib, AKI, dysglycemia) compared to a traditional fentanyl and hydromorphine regimen after cardiac surgery. Additionally, it aims to investigate if the benefit of multimodal regimen is achieved by combination of all drugs or all drugs except dexmedetomodine by introducing third group of study patients who will be randomized to all interventions except saline placebo instead of dexmedetomodine infusion.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03521167
- Europe PMC full search
- ASCO Meeting Library
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03521167 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Zhongshan Hospital
- Last refreshed: 11 May 2018
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