Impact of deep neuromuscular block versus inhalation and TIVA on laparoscopic surgical workspace

Impact of deep neuromuscular block versus inhalation and TIVA on laparoscopic surgical workspace - N/A

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002581-39-BE

Enrollment

Registered

2014-04-11

Start date

2014-05-05

Completion date

Unknown

Last updated

2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Not applicable

Interventions

Trade Name: ULTIVA (R) Product Name: Remifentanyl Product Code: Remifentanyl Pharmaceutical Form: Powder for concentrate for solution for injection/infusion Other descriptive name: REMIFENTANIL HYDROC

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Laparoscopic bariatric surgery in a patient older than 18 years of age without previous laparotomy. Examples of laparoscopic bariatric procedures are gastric band, sleeve gastrectomy, gastric bypass, gastric bypass after lap band, and revision of a gastric bypass. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1.Allergies or contraindications to the use of one or more of the following drugs: propofol, rocuronium, sugammadex, remifentanyl, or sevoflurane. 2.History of a laparotomy. 3.Emergency laparoscopy

Design outcomes

Primary

Measure	Time frame
Main Objective: 1.Primary Efficacy Objective: To compare the impact of the following agents on the reduction in active muscle tonus during laparoscopy: remifentanyl > 0.50 µg/kg/min; sevoflurane > 1 MAC and deep neuromuscular block (rocuronium given with PTC < 4). 2.Primary Safety Objective: To compare the adverse events among the patient groups who receive the different agents listed above in the “primary efficacy objective,” ;Secondary Objective: not applicable;Primary end point(s): 1.High dose remifentanyl does not increase laparoscopic surgical workspace compared to deep NMB (PTC < 4). 2.1 MAC inhalation with sevoflurane does not increase laparoscopic surgical workspace compared to deep NMB ( PTC < 4) 3.Surgeons will encounter more workspace problems when no NMB is used. ;Timepoint(s) of evaluation of this end point: not applicable	—

Measure

Time frame

Main Objective: 1.Primary Efficacy Objective: To compare the impact of the following agents on the reduction in active muscle tonus during laparoscopy: remifentanyl > 0.50 µg/kg/min; sevoflurane > 1 MAC and deep neuromuscular block (rocuronium given with PTC < 4). 2.Primary Safety Objective: To compare the adverse events among the patient groups who receive the different agents listed above in the “primary efficacy objective,” ;Secondary Objective: not applicable;Primary end point(s): 1.High dose remifentanyl does not increase laparoscopic surgical workspace compared to deep NMB (PTC < 4). 2.1 MAC inhalation with sevoflurane does not increase laparoscopic surgical workspace compared to deep NMB ( PTC < 4) 3.Surgeons will encounter more workspace problems when no NMB is used. ;Timepoint(s) of evaluation of this end point: not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable	—

Countries

Belgium

Contacts

Public ContactJan Paul Mulier

AZ Sint Jan Brugge-Oostende AV

jan.mulier@azsintjan.be+3250422490

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026