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NCT01937767
A Randomized, Single-blind Phase II Study Evaluating the Efficacy, Safety and Pharmacokinetics of Remimazolam in General Anesthesia in Adult Patients Undergoing Cardiac Surgery, Including Follow-up Sedation in the PACU/ICU
Phase 2 trial testing Remimazolam in General Anesthesia in 90 participants. Completed in 19 February 2014.
1 February 2014
Quick facts
| Lead sponsor | Paion UK Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 90 |
| Start date | 1 August 2013 |
| Primary completion | 1 February 2014 |
| Estimated completion | 19 February 2014 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Remimazolam
- Propofol (Propofol) — full drug profile →
- Sevoflurane — full drug profile →
- Remifentanil
- Fentanyl (fentanyl) — full drug profile →
- Rocuronium (ROCURONIUM) — full drug profile →
Conditions studied
- General Anesthesia — all drugs for General Anesthesia →
Sponsor
Paion UK Ltd. — full company profile →
Who can join
18 and older, any sex, with General Anesthesia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Proportion of patients with successful anesthesia
Time frame: Between the start of study medication and the end of the surgical procedure (up to approx 12 hours)
Successful anesthesia was defined as no use of rescue sedative medication between start of the study medication and end of the surgical procedure completion of last skin suture.
Sponsor's own description
This phase II study in patients undergoing elective cardiac surgery will evaluate the efficacy, safety, and pharmacokinetics of remimazolam, compared with propofol and sevoflurane, during the induction and maintenance of general anesthesia.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Remimazolam: Non-Clinical and Clinical Profile of a New Sedative/Anesthetic Agent.
Kilpatrick GJ. · · 2021 · cited 190× · PMID 34354587 · DOI 10.3389/fphar.2021.690875
Verify or expand the search:
- PubMed search for NCT01937767
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Remimazolam
Trials testing the same drug.
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- NCT07459322 — The Use of Remimazolam Versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy · NA · not yet recruiting
- NCT07290205 — Remimazolam NeuroImaging · EARLY_PHASE1 · recruiting
- NCT07269808 — Sedation During Endoscopy Using Remimazolam: Efficacy in a Novel Exploration · Phase 3 · recruiting
- NCT06231563 — Ketamine for Veterans With Parkinson's Disease · Phase 2 · recruiting
Other recruiting trials for General Anesthesia
Currently open trials in the same condition.
- NCT07323420 — Effects of Different Inspiratory:Expiratory Ratios on Respiratory and Recovery Outcomes During Dental Procedures Under G · recruiting
- NCT07321041 — Effect of Delivery Time on Umbilical Cord Blood Gas Parameters in Cesarean Sections Under General and Spinal Anesthesia · recruiting
- NCT07280546 — Analysis of Breath Sounds During Surgery · recruiting
- NCT07203287 — Risk of Acute Complications With Rocuronium vs Cisatracurium in Patients With Chronic Kidney Disease · Phase 4 · recruiting
- NCT07074730 — General Anesthesia Versus Spinal Anesthesia With Local Anesthetic Infiltration for Buccal Mucosal Graft in Urethroplasty · NA · recruiting
Other Paion UK Ltd. trials
Trials by the same sponsor.
- NCT04670471 — Assessment of the Pharmacodynamic and Pharmacokinetic Interaction of Remimazolam and Remifentanil · Phase 1 · completed
- NCT03661489 — Efficacy and Safety of Remimazolam (CNS7056) Compared to Propofol for Intravenous Anesthesia During Elective Surgery · Phase 3 · completed
- NCT04113343 — Oral Remimazolam With and Without Alcohol in Healthy Female Subjects · Phase 1 · completed
- NCT03329014 — A Trial of Intranasal Remimazolam Pharmacokinetics, Pharmacodynamics, Safety and Bioavailability · Phase 1 · completed
- NCT04113564 — Absolute Oral Bioavailability of Remimazolam · Phase 1 · completed
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 NCT01937767 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Paion UK Ltd.
- Last refreshed: 15 January 2020
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/NCT01937767.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing