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

Laparoscopic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04688268
• Other study ID #: B-2008/633-302
• Status: Not yet recruiting
• Start date: January 10, 2021
• Est. completion date: July 30, 2021

Study information

• Verified date: December 2020
• Source: Seoul National University Bundang Hospital
• Contact: Jiwon Han, Dr
• Phone: 82-10-3447-1988
• Email: hanjiwon[@]snubh.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Surgery

Intervention

Drug:
• deep neuromuscular blockade
Train of Four=0/4, Post tetanic count 1-2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Recovery time	time from sugammadex injection to TOF ratio > 0.9	preoperative 1 days to postoperative 1 days