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Effect of depth of neuromuscular block on intraoperative surgical conditions as determined by the Leiden Surgical Rating Scale in morbidly obese patients undergoing laparoscopic bariatric surgery

Effect of depth of neuromuscular block on intraoperative surgical conditions as determined by the Leiden Surgical Rating Scale in morbidly obese patients undergoing laparoscopic bariatric surgery - BLISS 3

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44073
Enrollment
100
Registered
2015-06-16
Start date
2015-09-22
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

obesitas perioperative surgical conditions

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: ASA 1-3, 18 years or older; BMI > 34 kg/m2; ability to give informed consent; elective bariatric surgery.

Exclusion criteria

Exclusion criteria: Known or suspected neuromuscular disorders impairing neuromuscular function; allergies to muscle relaxants, anesthetics or narcotics; A (family) history of malignant hyperthermia; Women who are or may be pregnant or are currently breast feeding; Renal insufficiency

Design outcomes

Primary

MeasureTime frame
Surgical conditions, with as main research question *Does a deep surgical block indeed improve surgical conditions in case of laparoscopic surgery in morbidly obese patients for bariatric surgery?* The surgical condition will be determined from a surgical rating condition scale, the Leiden Surgical rating Scale. This is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The surgeon will score the condition at 15 min intervals. At the time of scoring also the intra-abdominal pressure will be monitored.

Secondary

MeasureTime frame
Secondary end-points include: (1) The hemodynamics during surgery with the main research question *Does a deep neuromuscular block coincide with improved hemodynamics during surgery and less postoperative pain?* (2) Cardiorespiratory conditions in the post-anesthesia care unit, with the main research question *What is the effect of reversal with Sugammadex of a deep surgical muscle block on postoperative breathing activity as measured by respiratory rate and saturation* (3) Pain and sedation in the post-anesthesia care unit, with the main research question *Does a deep block coincide with less pain compared to a moderate block in the recovery period?* and (4) The Postoperative Quality of Recovery Scale (PQRS), with the main question *Irrespective of depth of the neuromuscular block during surgery, is the quality of recovery similar in patients that were reversed with sugammadex*.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)