Study on the Level of Neuromuscular Blockade

The First Affiliated Hospital with Nanjing Medical University83 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neuromuscular Blockade

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

50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.5-0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).

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

33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2-0.3 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Plasma Concentration of D-lactic Acid Before the Surgery

The level of D-lactic acid can indicate the damage to the gastrointestinal barrier .

Time frame: 1 day before the surgery

Plasma Concentration of Diamine Oxidase (DAO) Before the Surgery

The level of DAO can indicate the damage to the gastrointestinal barrier .

Time frame: 1 day Before the Surgery

Total Number of Operational Taxonomic Units (OUTs) of Intestinal Microbiota

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.

Time frame: the first time of defecation after operation

Postoperative Exhaust Time

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.

Time frame: 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

The level of D-lactic acid can indicate the damage to the gastrointestinal barrier .

Time frame: 24 h after the surgery

Data from ClinicalTrials.gov

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Secondary Outcomes

Duration of Surgery

Time from the first dose of anesthetic to the end of the surgery

Time frame: From the first dose of anesthetic to the end of the surgery

Surgical Condition Scores Rated by Surgeons

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.

Time frame: During operation, within 2 hours

Duration of CO2 Pneumoperitoneum

Time from the beginning to the end of CO2 pneumoperitoneum

Time frame: from the beginning to the end of CO2 pneumoperitoneum

Duration of Postoperative Hospital Stay

Duration from the day of surgery to the day the patient discharged from the hospital

Time frame: from the end of surgery to the time of being discharged from hospital

Postoperative VAS (12 h After Surgery, Rest State)