Status:
COMPLETED
Effectiveness of Deep Versus Moderate Neuromuscular Blockade
Lead Sponsor:
Asan Medical Center
Conditions:
Neuromuscular Blockade
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief Summary
The aim of this study is to evaluate the influence of depth of neuromuscular blockade during laparoscopic gastrectomy on postoperative pain in surgical patients allocated randomly to either deep or mo...
Detailed Description
* All patients were fasted from midnight without premedication * Once in the operating room, the patients were monitored using electrocardiography, pulse oximetry, end-tidal carbon dioxide partial pre...
Eligibility Criteria
Inclusion
- Patients 20 to 65 years old
- American Society of Anesthesiologist Physical Status 1, 2 or 3
- Patients undergoing laparoscopic gastrectomy
- Patients who signed a written informed consent form
Exclusion
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test
- Patients with known hypersensitivity to rocuronium or sugammadex
- Patient with VAS score (0=no pain; 100=the most severe pain) of at least 10 before surgery
- Patients with liver cirrhosis confirmed by abdominal CT
- Patients with neuromuscular disease that may interfere with neuromuscular data (ex. Duchenne muscular dystrophy, myasthenia gravis)
- Clinically significant impairment of cardiovascular function, defined by ejection fraction \< 50%
- Clinically significant impairment of renal function, defined by estimated GFR \< 60 ml/min or need for hemodialysis
- Clinically significant impairment of liver function, defined by alanine aminotransferase \> 100 IU/L
- Indication for rapid sequence induction
- Use of opioids within the 7 days prior to surgery
- History of abdominal surgery
- History of chronic obstructive pulmonary disease
- Body mass index (BMI) ≥ 35 kg/m2
- Body weight \< 50 kg
- Conversion to laparotomy
- Family history of malignant hyperthermia
- Patients who are considered by the investigator to be unsuitable to participate in the study for any other reason not mentioned in the inclusion and exclusion criteria
Key Trial Info
Start Date :
March 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03266419
Start Date
March 28 2018
End Date
November 2 2018
Last Update
November 13 2019
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 05505