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Optimization of surgical conditions during laparoscopic cholecystectomy with deep or moderate neuromuscular blockade
2011-005502-29Phase 4
Key facts
- Status
- Completed
- Start
- Jan 2012
- Countries
- 1
- Sponsor
- Mona R Gätke
- Modality
- Small Molecules, Biodegradable Polymers → Polymer-based Nanoparticles → Nanoparticles → Drug Delivery Systems
- Drugs
- rocuroniumSugammadex
01
Overview
Phase 4, randomised trial of rocuronium and Sugammadex in None (2 arms), sponsored by Mona R Gätke. Primary endpoint: Primary endpoint: poorest intraoperative surgical conditions (4-stage scale). Started Jan 2012; status: completed.
02
Design
2 arms- Study design
- Randomized
Deep neuromuscular blockade
Patients receive deep neuromuscular blockade with rocuronium bromide during low-pressure laparoscopic cholecystectomy, followed by reversal with sugammadex.
Moderate neuromuscular blockade
Patients receive moderate neuromuscular blockade with rocuronium bromide during low-pressure laparoscopic cholecystectomy, followed by reversal with sugammadex.
03
Who it enrols
Adults older than 18 years undergoing laparoscopic cholecystectomy; patients with known allergy to study medications (rocuronium bromide or sugammadex) are excluded.
04
Endpoints
Primary
Primary endpoint: poorest intraoperative surgical conditions (4-stage scale)
Secondary
Secondary endpoint: overall surgical conditions (VAS 0–100)
Secondary endpoint: postoperative pain level
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