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Effect of deep versus moderate neuromuscular block during sevoflurane anesthesia on intraoperative surgical conditions, hemodynamics and postoperative pain in patients undergoing laparoscopic surgery for (donor) nephrectomy *

Effect of deep versus moderate neuromuscular block during sevoflurane anesthesia on intraoperative surgical conditions, hemodynamics and postoperative pain in patients undergoing laparoscopic surgery for (donor) nephrectomy * - BLISS 4

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48952
Enrollment
100
Registered
2019-09-17
Start date
2018-06-13
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

anesthesie voor utrologische laparoscopische ingrepen anesthesia narcosis

Interventions

anesthesia
neuromuscular block
relaxation
surgical rating

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: (i) Patients diagnosed who are will undergo an elective laparoscopic renal surgical procedure, i.e. (donor) nephrectomy (ii) ASA class I-III (iii) > 18 years of age; (iv) Ability to give oral and written informed consent.

Exclusion criteria

Exclusion criteria: (i) Known or suspected neuromuscular disorders impairing neuromuscular function; (ii) Allergies to muscle relaxants, anesthetics or narcotics; (iii) A (family) history of malignant hyperthermia; (iv) Women who are or may be pregnant or are currently breast feeding; (v) Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output 35 kg/m2

Design outcomes

Primary

MeasureTime frame
The main end-point of the study is the effect of the deep block on surgical conditions during sevoflurane anesthesia. To that end-the surgical team will be asked to rate the quality of the surgical field at 15-min intervals using the 5-point Leiden-Surgical Rating Scale (L-SRS), a scale that was previously developed at LUMC and recently validated

Secondary

MeasureTime frame
Secondary end-points of the study are hemodynamics (blood pressure and heart rate) and Nociception Level (NoL [3]) during anesthesia, and pain and sedation scores following surgery.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)