Study on the Level of Neuromuscular Blockade

Not Applicable

Completed

Conditions: Neuromuscular Blockade

Interventions: 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: 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).

Registration Number: NCT03782233

Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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)

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 83

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
moderate neuromuscular blockade group (Group M)	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).	Patients undergoing elective laparoscopic surgery for gastrectomy will be randomized to receive moderate neuromuscular blockade (train-of-four count = 1-2) using moderate dose rocuronium.
deep neuromuscular blockade group (Group D)	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).	Patients undergoing elective laparoscopic surgery for gastrectomy will be randomized to receive deep neuromuscular blockade (post-tetanic count = 1-2) using high dose rocuronium.

Primary Outcome Measures

Name	Time	Method
Plasma Concentration of Diamine Oxidase (DAO) 24 h After the Surgery	24 h after the Surgery	The level of DAO can indicate the damage to the gastrointestinal barrier .
Plasma Concentration of D-lactic Acid Before the Surgery	1 day before the surgery	The level of D-lactic acid can indicate the damage to the gastrointestinal barrier .
Plasma Concentration of Diamine Oxidase (DAO) Before the Surgery	1 day Before the Surgery	The level of DAO can indicate the damage to the gastrointestinal barrier .
Total Number of Operational Taxonomic Units (OUTs) of Intestinal Microbiota	the first time of defecation after operation	Intestinal microbiota was analyzed by 16S rRNA sequencing. To be specific, first, DNA was extracted and quantified. Bacterial 16S rRNA genes of the V3-V4 region were amplified from extracted DNA using the barcoded primers (5'- CCTACGGRRBGCASCAGKVRVGAAT-3') and (5'- GGACTACNVGGGTWTCTAATCC-3'). PCR reactions were performed and the PCR mixture applied to the PCR amplifier. Then, the PCR products were checked for size and specificity by agarose gel electrophoresis and purified. Finally, high-throughput sequencing was performed using the Illumina MiSeq platform. The raw reads were filtered to remove low quality sequences and the filtered data were further merged into tags by FLASH(Version 1.2.7). Then the Uchime algorithm in Usearch software was applied to remove chimeric tags. Resulting tags for each sample were clustered into operational taxonomic units(OTUs) at the level of 97% similarity. Higher values represent a more abundant amount of bacteria in gut.
Postoperative Exhaust Time	It is calculated from the end of the operation to the time of exhaust.	It's a regular measurement to evaluate the function of gastrointestinal tract . It is calculated from the end of the operation to the time of exhaust.
Plasma Concentration of D-lactic Acid 24 h After the Surgery	24 h after the surgery	The level of D-lactic acid can indicate the damage to the gastrointestinal barrier .
16s rRNA Sequencing of Postoperative Feces	the first time of defecation after operation	Alpha and Beta diversity; relative abundance of gut microbiota. Alpha diversity includes Chao 1 index, Shannon index, and Simpson index. A higher value of Chao 1 index corresponds to more abundant number of microbiota. A higher value of Shannon index corresponds to more abundance. And A higher value of Simpson index corresponds to less diversity. Bata diversity was assessed by PCoA analysis. A three dimensional scatter plot was presented to visualize the similarities and differences between the two groups.
Relative Abundance of Intestinal Microbiota	the first time of defecation after operation	Intestinal microbiota is one of the factors related to the recovery of intestinal function. It can be analyzed by 16S rRNA sequencing of the postoperative feces.

Secondary Outcome Measures

Name	Time	Method
Postoperative VAS (12 h After Surgery, Rest State)	12 h after surgery	VAS pain score: 0 - completely painless, 10 - unbearable pain.
Postoperative VAS (12 h After Surgery, Active State)	12 h after surgery	VAS pain score: 0 - completely painless, 10 - unbearable pain.
Postoperative VAS (24 h After Surgery, Rest State)	24 h after surgery	VAS pain score: 0 - completely painless, 10 - unbearable pain.
Duration of Surgery	From the first dose of anesthetic to the end of the surgery	Time from the first dose of anesthetic to the end of the surgery
Surgical Condition Scores Rated by Surgeons	During operation, within 2 hours	evaluation of the surgical condition by 5 point scale: 5 points: optimal; 4 points: good; 3 points: acceptable; 2 points: poor; 1 point: extremely poor.
Duration of CO2 Pneumoperitoneum	from the beginning to the end of CO2 pneumoperitoneum	Time from the beginning to the end of CO2 pneumoperitoneum
Duration of Postoperative Hospital Stay	from the end of surgery to the time of being discharged from hospital	Duration from the day of surgery to the day the patient discharged from the hospital
Postoperative VAS (24 h After Surgery, Active State)	24 h after surgery	VAS pain score: 0 - completely painless, 10 - unbearable pain.
Surgical Condition Scores Rated by Surgeons (Average Scores)	during surgery	evaluation of the surgical condition by 5 point scale: 5 points: optimal; 4 points: good; 3 points: acceptable; 2 points: poor; 1 point: extremely poor.
Postoperative VAS (48 h After Surgery, Rest State)	48 h after surgery	VAS pain score: 0 - completely painless, 10 - unbearable pain.
Postoperative VAS (48 h After Surgery, Active State)	48 h after surgery	VAS pain score: 0 - completely painless, 10 - unbearable pain.