Dose for Deep Neuromuscular Blockade Deciding Factor of Neuromuscular Blocker Dose for Deep Neuromuscular Blockade

Find Out the Deciding Factor of Neuromuscular Blocker Dose for Deep Neuromuscular Blockade

Find out the deciding factor(total body weight, corrected body weight, ideal body weight, fat-free mass, body mass index, skeletal muscle mass, body fat) of neuromuscular blocker dose for deep neuromuscular blockade.

Study Overview

• Status: Unknown
• Conditions: Laparoscopic Surgery
• Intervention / Treatment: Drug: deep neuromuscular blockade

Detailed Description

Before the surgery, total body weight, corrected body weight, ideal body weight, fat-free mass, body mass index were measured by height and weight and skeletal muscle mass and body fat were measured by Bioelectrical impedance analysis (InbodyH20N). Find the highest correlation between the 8 factors (total body weight, corrected body weight, ideal body weight, fat-free mass, body mass index, skeletal muscle mass, body fat) and the amount of rocuronium administered to deep neuromuscular blockade.

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients aged 20-80 and American Society of Anesthesiology Physical Grade (ASA) I-II, who undergo laparoscopic surgery for at least 2 hours under general anesthesia.

Description

Inclusion Criteria:

• patients aged 20-80 and American Society of Anesthesiology Physical Grade (ASA) I-II, who undergo laparoscopic surgery for at least 2 hours under general anesthesia

Exclusion Criteria:

• kidney disease (GFR<60)
• allergy to study drugs
• decline participation
• side effect of propofol and remifentanil
• when anesthesia does not maintain the level of alertness (BIS) below 60 even when the anesthetic dose is increased, or when hemodynamic instability such as bradycardia and hypotension appears

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
deep neuromuscular blockade; patients who underwent surgery with deep neuromuscular blockade	Drug: deep neuromuscular blockade; Train of Four=0/4, Post tetanic count 1-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the highest correlation coefficient	the relationship of rocuronium for deep neuromuscular blockade and 8 factors (corrected body weight, ideal body weight, lean body weight, fat-free mass, body mass index, skeletal muscle mass, body fat)	preoperative 1 days to postoperative 1 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
onset time of rocuronium	time from injection of rocuronium 0.6 mg/kg(TBW) to TOF ratio is less than 0.05	preoperative 1 days to postoperative 1 days
Recovery time	time from sugammadex injection to TOF ratio > 0.9	preoperative 1 days to postoperative 1 days
Time to deep neuromuscular blockade	time from injection of rocuronium 0.6 mg/kg(TBW) to PTC 1	preoperative 1 days to postoperative 1 days

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• Choi YJ, Hee Kim Y, Bae GE, Yu JH, Yoon SZ, Kang HW, Lee KS, Kim JH, Lee YS. Relationship between the muscle relaxation effect and body muscle mass measured using bioelectrical impedance analysis: A nonrandomized controlled trial. J Int Med Res. 2019 Apr;47(4):1521-1532. doi: 10.1177/0300060518822197. Epub 2019 Feb 5.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 10, 2021
• Primary Completion (Anticipated): July 30, 2021
• Study Completion (Anticipated): July 30, 2021

Study Registration Dates

• First Submitted: December 23, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: laparoscopic surgery; deep neuromuscular blockade
• Other Study ID Numbers: B-2008/633-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No