N/A
N=131
Effects of Neuromuscular Blockade Level and Intra-abdominal Pressure on Surgical Conditions and Cardiopulmonary Responses During Laparoscopic Colon Surgery With the Trendelenburg Position
Cardiac Index
Bottom Line
View on ClinicalTrials.gov: NCT02249585 ↗Enrolled (actual)
131
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Cardiac Index — 2.6; 2.7; 2.7 L/min/m^2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard abdominal pressure (Device); Low abdominal pressure (Device); Conventional neuromuscular blockade (Drug); Deep neuromuscular blockade (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiac Index |
2.6; 2.7; 2.7 | — |
| SECONDARY Mean Arterial Blood Pressure (MBP) |
88; 92; 90; 89; 92; 91 | — |
| SECONDARY Stroke Volume Index (SVI) |
37; 41; 38; 38; 42; 40 | — |
| SECONDARY PaO2 |
25; 26; 27; 25; 26; 27 | — |
| SECONDARY Pulmonary Compliance |
29; 29; 34; 24; 25; 28 | — |
| SECONDARY Surgical Rating Scale |
33; 37; 20; 3; 7; 6 | — |
Summary
The purpose of this study is to find out the effect of low abdominal pressure vs. standard abdominal pressure on the cardiac and respiratory function of the patients undergoing laparoscopic colon surgery in Trendelenberg position. It was also designed to evaluate the effect of the degree of neuromuscular blockade on the surgical condition of the patients undergoing laparoscopic colon surgery in Trendelenberg position.
Eligibility Criteria
Inclusion Criteria
- Patients scheduled for laparoscopic colon surgery under Trendelenberg position
Exclusion Criteria
- ASA classification IV
- Unable to make a written, informed consent
- Allergic to neuromuscular blocking agents, anesthetics, opioids
- Patients with neuromuscular disease
- Hepatic failure
- Renal failure
- History of malignant hyperthermia
- Morbid obesity with BMI>35 kg/m2
- Patients enrolled in another clinical trials
Data sourced from ClinicalTrials.gov (NCT02249585). 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.