N/A N=83 Randomized Treatment

Study on the Level of Neuromuscular Blockade

Neuromuscular Blockade

Bottom Line

View on ClinicalTrials.gov: NCT03782233 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcome: Primary: Plasma Concentration of D-lactic Acid Before the Surgery — 1100.4; 1087.8 ng/ml

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: A continuous intravenous infusion of 0.5-0.6 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (PTC = 1-2). (Drug); A continuous intravenous infusion of 0.2-0.3 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (TOF = 1-2). (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Plasma Concentration of D-lactic Acid Before the Surgery	1100.4; 1087.8	—
PRIMARY Plasma Concentration of Diamine Oxidase (DAO) Before the Surgery	15.5; 16.4	—
PRIMARY Total Number of Operational Taxonomic Units (OUTs) of Intestinal Microbiota	1695; 1287	—
PRIMARY Postoperative Exhaust Time	58.9; 70.5	—
PRIMARY Plasma Concentration of D-lactic Acid 24 h After the Surgery	1230.7; 1297.5	—
PRIMARY Plasma Concentration of Diamine Oxidase (DAO) 24 h After the Surgery	18.1; 26.5	—
PRIMARY Relative Abundance of Intestinal Microbiota	0.0010483424321; 0.0010483424321; 0; 0.000019780046; 0.0081493789065; 0.0010483424321	—
PRIMARY 16s rRNA Sequencing of Postoperative Feces	763.7; 599.3; 4.93; 4.15; 0.9; 0.83	—
SECONDARY Duration of Surgery	155.0; 174.6	—
SECONDARY Surgical Condition Scores Rated by Surgeons	0; 1; 0; 4; 3; 16	—
SECONDARY Duration of CO2 Pneumoperitoneum	132.3; 147.0	—
SECONDARY Duration of Postoperative Hospital Stay	9.2; 9.1	—
SECONDARY Postoperative VAS (12 h After Surgery, Rest State)	2.2; 2.1	—
SECONDARY Postoperative VAS (12 h After Surgery, Active State)	3.6; 3.8	—
SECONDARY Postoperative VAS (24 h After Surgery, Rest State)	1.3; 1.5	—
SECONDARY Postoperative VAS (24 h After Surgery, Active State)	2.7; 3.1	—
SECONDARY Postoperative VAS (48 h After Surgery, Rest State)	0.4; 0.7	—
SECONDARY Postoperative VAS (48 h After Surgery, Active State)	1.5; 1.5	—
SECONDARY Surgical Condition Scores Rated by Surgeons (Average Scores)	4.6; 3.2	—

Summary

On the basis of moderate pneumoperitoneum pressure(10 mmHg), this study evaluates the effect of different level of neuromuscular blockade to gastrointestinal barrier function during laparoscopic gastrectomy. 83 patients are randomized to 2 arms ,The patients in deep neuromuscular blockade group（group D, PTC=1-2）will receive high dose rocuronium (0.5-0.6 mg/kg/h) ;While the patients in moderate neuromuscular blockade group（group M, TOF=1-2）will receive moderate dose rocuronium (0.2-0.3 mg/kg/h)

Eligibility Criteria

Inclusion Criteria

Age:40-80;
BMI < 30kg/m2；
ASA classification:Ⅰ-Ⅲ；
Undergoing elective laparoscopic gastrectomy.

Exclusion Criteria

Preoperative history of inflammatory intestinal diseases, intestinal flora disorders, obstructive jaundice, intestinal obstruction, irritable bowel syndrome and other digestive diseases;
Severe heart, lung, liver, kidney, brain and other diseases;
Serious infection, pancreatitis, burns, trauma, need a large dose, long-term use of antibiotics before the operation;
A history of abdominal surgery;
Combined with gravis myasthenia, serious electrolyte disorders or neuromuscular diseases.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03782233). 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.