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N/A Completed N=40 Randomized Triple-blind Treatment

Effect of Neuromuscular Block and Arterial PCO2 on Surgical Rating Scale (SRS), Following Reversal With Sugammadex

Source: ClinicalTrials.gov NCT01968447 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Surgical Rating Scale — 4.86; 4.75 units on a scale — p=0.59

Summary

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Surgical Rating Scale
4.86; 4.75 0.59
SECONDARY
Hemodynamics
85; 81 —
SECONDARY
Respiratory Function
98.6; 98.5 —
SECONDARY
Pain Intensity on an 11-point Scale in the Postoperative Period
4.1; 4.0 —
SECONDARY
Sedation
2.4; 2.3 —
SECONDARY
Nausea
3.6; 5.9 —
SECONDARY
Vomiting
0; 3.9 —

Eligibility 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

  • (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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01968447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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