Clinical trial · Interventional
Effect of Neuromuscular Block and Arterial PCO2 on Surgical Rating Scale (SRS), Following Reversal With Sugammadex
Effect of Deep Neuromuscular Block and Variations in Arterial PCO2 on the Surgical Rating Scale (SRS), Extubation Conditions and Postoperative Conditions Following Reversal With Sugammadex
NCT01968447CI-TRIAL-00044018BLISSS2completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to study the effect of variations in the arterial CO2 concentration during deep neuromuscular block on the surgical conditions as assessed by the surgical rating scale
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hypocapnia | Other | — | UNRESOLVED |
| normocapnia | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- hypocapnia
- description
- arterial pCO2 of 3.5 kPa
- interventionNames
- Other: hypocapnia
- type
- ACTIVE_COMPARATOR
- label
- normocapnia
- description
- arterial PCO2 of 6.5-7.0 kPa
- interventionNames
- Other: normocapnia
Primary outcomes (1)
- measure
- Surgical Rating Scale
- timeFrame
- Peroperative
- description
- During a procedure, the surgical condition will be scored by one surgeon using a 5-point surgical rating scale. The rating scale is a 5-point ordinal scale ranging from 1 = poor condition to 5 = optimal surgical conditions. The surgeon will score the condition at 15 minute intervals.The values given on the surgical rating scale are averaged and the average value is used in the data analysis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: * (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 \< 0.5 ml/kg/h for at least 6 h. When available, other indices will be taken into account as well such as glomerular filtration rate \< 60 ml/h and proteinuria (a ratio of 30 mg albumin to 1 g of creatinine). * (vi) Previous retroperitoneal surgery at the site of the current surgery. * (vii) Body mass index \> 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)
References
Publications (1)
- DERIVEDBoon M, Martini C, Hellinga M, Bevers R, Aarts L, Dahan A. Influence of variations in arterial PCO2 on surgical conditions during laparoscopic retroperitoneal surgery. Br J Anaesth. 2016 Jul;117(1):59-65. doi: 10.1093/bja/aew114. Epub 2016 May 6. PMID 27154574