Last reviewed · How we verify
NCT04144933: RUMBLE
Effect of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery
Phase 3 trial testing Acetaminophen, Gabapentin in Anesthesia in 60 participants. Status unknown.
30 July 2024
Quick facts
| Lead sponsor | University of Saskatchewan |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 15 May 2021 |
| Primary completion | 30 July 2024 |
| Estimated completion | 1 August 2024 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Acetaminophen, Gabapentin — full drug profile →
- Acetaminophen, Gabapentin — full drug profile →
- Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine — full drug profile →
- Dexamethasone, Ondansetron
- Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate — full drug profile →
- Lidocaine 1% Injectable Solution, Sufentanil — full drug profile →
- Sevoflurane, Sufentanil — full drug profile →
Conditions studied
- Anesthesia — all drugs for Anesthesia →
- General Anesthesia — all drugs for General Anesthesia →
- Analgesics, Opioid — all drugs for Analgesics, Opioid →
- Opioid Free Anesthesia — all drugs for Opioid Free Anesthesia →
Sponsor
University of Saskatchewan
Who can join
18 and older, any sex, with Anesthesia or General Anesthesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study is to determine if an opioid-free general anesthetic (OFA) technique utilizing lidocaine, ketamine, dexmedetomidine and magnesium reduce postoperative opioid consumption and speed return of bowel function in patients undergoing elective, laparoscopic, colorectal surgery compared to traditional opioid-containing general anesthetic techniques. It is hypothesized that this intraoperative OFA regimen will reduce postoperative opioid consumption, and expedite return of bowel function in this population.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04144933
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT04144933 (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 University of Saskatchewan
- Last refreshed: 20 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04144933.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing