Effect of deep neuromuscular block and variations in arterial PCO2 on the surgical rating scale, extubation conditions and postoperative conditions following reversal with sugammadex

Effect of deep neuromuscular block and variations in arterial PCO2 on the surgical rating scale, extubation conditions and postoperative conditions following reversal with sugammadex - BLISS 2

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38910

Enrollment

Registered

2013-09-30

Start date

2014-01-27

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

niercelcarcinoom prostaatcarcinoom

Interventions

Two patient groups, one in which the arterial CO2 concentration is controlled to values of 3.5 kPa or 26.3 mmHg (GROUP 1

n=20), the other in which the target is 6.5-7.0 kPa or 48.8-52.5 mmHg (GROUP 2

n=20). Variations in arterial CO2 concentration are applied by changes in minute ventilation. All surgical procedures will be performed by one surgeon.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: (i) Patients diagnosed with renal or prostatic disease who are will undergo an elective laparoscopic renal surgical procedure or laparoscopic prostatectomy; (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 (viii) Chronic obstructive pulmonary disease GOLD 2-4 or a FEV1 less than 70% predicted or VC less than 70% predicted (ix) chronic pulmonary disease with altered lung physiology (eg. sarcoidosis, cycstic fibrosis, obstructing pulmonary tumors, previous lung surgery)

Design outcomes

Primary

Measure	Time frame
To study the surgical conditions in patients undergoing laparoscopic renal or prostate surgery during low and normal arterial PCO2 levels as assessed by the surgical rating scale.	—

Secondary

Measure	Time frame
To assess the relation between scoring of surgical conditions by the surgeon and video assisted scoring of surgical conditions. To study the hemodynamic conditions during low arterial CO2 concentration (3.5 kPa or 26.3 mmHg) versus normal arterial CO2 concentration (6.5-7.0 kPa or 48.8-52.5 mmHg ) To assess respiratory function, pain, nausea/vomiting postoperative following anesthesia maintained at low or normal arterial CO2 concentration To assess whether a deep neuromuscular block (PTC 1-2) combined with induction of relative hypocapnia (PaCO2 3.5 kPa or 26.3 mmHg) and reversal with sugammadex (4 mg/kg) will result in extubation within 5-min following reversal and excellent postoperative respiratory conditions.	—

Measure

Time frame

To assess the relation between scoring of surgical conditions by the surgeon and video assisted scoring of surgical conditions. To study the hemodynamic conditions during low arterial CO2 concentration (3.5 kPa or 26.3 mmHg) versus normal arterial CO2 concentration (6.5-7.0 kPa or 48.8-52.5 mmHg ) To assess respiratory function, pain, nausea/vomiting postoperative following anesthesia maintained at low or normal arterial CO2 concentration To assess whether a deep neuromuscular block (PTC 1-2) combined with induction of relative hypocapnia (PaCO2 3.5 kPa or 26.3 mmHg) and reversal with sugammadex (4 mg/kg) will result in extubation within 5-min following reversal and excellent postoperative respiratory conditions.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)