Clinical trial NCT03782233: Study on the Level of Neuromuscular Blockade
Official title: Effect to Gastrointestinal Barrier Function During Laparoscopic Gastrectomy With Deep vs Moderate Neuromuscular Blockade.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Blockade
Keywords: Neuromuscular Blockade
Gastrointestinal Barrier Function
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Wu Jieping Medical Foundation
First posted: 2018-12-20
Enrollment: 83
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Plasma Concentration of D-lactic Acid Before the Surgery
timeFrame: 1 day before the surgery
measure: Plasma Concentration of Diamine Oxidase (DAO) Before the Surgery
timeFrame: 1 day Before the Surgery
measure: Total Number of Operational Taxonomic Units (OUTs) of Intestinal Microbiota
timeFrame: the first time of defecation after operation
measure: Postoperative Exhaust Time
timeFrame: It is calculated from the end of the operation to the time of exhaust.
measure: Plasma Concentration of D-lactic Acid 24 h After the Surgery
timeFrame: 24 h after the surgery
measure: Plasma Concentration of Diamine Oxidase (DAO) 24 h After the Surgery
timeFrame: 24 h after the Surgery
measure: Relative Abundance of Intestinal Microbiota
timeFrame: the first time of defecation after operation
measure: 16s rRNA Sequencing of Postoperative Feces
timeFrame: the first time of defecation after operation
Secondary outcomes:
measure: Duration of Surgery
timeFrame: From the first dose of anesthetic to the end of the surgery
measure: Surgical Condition Scores Rated by Surgeons
timeFrame: During operation, within 2 hours
measure: Duration of CO2 Pneumoperitoneum
timeFrame: from the beginning to the end of CO2 pneumoperitoneum
measure: Duration of Postoperative Hospital Stay
timeFrame: from the end of surgery to the time of being discharged from hospital
measure: Postoperative VAS (12 h After Surgery, Rest State)
timeFrame: 12 h after surgery
measure: Postoperative VAS (12 h After Surgery, Active State)
timeFrame: 12 h after surgery
measure: Postoperative VAS (24 h After Surgery, Rest State)
timeFrame: 24 h after surgery
measure: Postoperative VAS (24 h After Surgery, Active State)
timeFrame: 24 h after surgery
measure: Postoperative VAS (48 h After Surgery, Rest State)
timeFrame: 48 h after surgery
measure: Postoperative VAS (48 h After Surgery, Active State)
timeFrame: 48 h after surgery
measure: Surgical Condition Scores Rated by Surgeons (Average Scores)
timeFrame: during surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
References: