Study on the Level of Neuromuscular Blockade

Neuromuscular Blockade Clinical Trial

Official title:

Effect to Gastrointestinal Barrier Function During Laparoscopic Gastrectomy With Deep vs Moderate Neuromuscular Blockade.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782233
• Other study ID #: He Huang
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2020
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age:40-80;

2. BMI < 30kg/m2;

3. ASA classification:?-?;

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.

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

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).
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).
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).

Locations

Country	Name	City	State
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University	Wu Jieping Medical Foundation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Concentration of D-lactic Acid Before the Surgery	The level of D-lactic acid can indicate the damage to the gastrointestinal barrier .	1 day before the surgery
Primary	Plasma Concentration of Diamine Oxidase (DAO) Before the Surgery	The level of DAO can indicate the damage to the gastrointestinal barrier .	1 day Before the Surgery
Primary	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.	the first time of defecation after operation
Primary	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.	It is calculated from the end of the operation to the time of exhaust.
Primary	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 .	24 h after the surgery
Primary	Plasma Concentration of Diamine Oxidase (DAO) 24 h After the Surgery	The level of DAO can indicate the damage to the gastrointestinal barrier .	24 h after the Surgery
Primary	Relative Abundance of Intestinal Microbiota	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.	the first time of defecation after operation
Primary	16s rRNA Sequencing of Postoperative Feces	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.	the first time of defecation after operation
Secondary	Duration of Surgery	Time from the first dose of anesthetic to the end of the surgery	From the first dose of anesthetic to the end of the surgery
Secondary	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.	During operation, within 2 hours
Secondary	Duration of CO2 Pneumoperitoneum	Time from the beginning to the end of CO2 pneumoperitoneum	from the beginning to the end of CO2 pneumoperitoneum
Secondary	Duration of Postoperative Hospital Stay	Duration from the day of surgery to the day the patient discharged from the hospital	from the end of surgery to the time of being discharged from hospital
Secondary	Postoperative VAS (12 h After Surgery, Rest State)	VAS pain score: 0 - completely painless, 10 - unbearable pain.	12 h after surgery
Secondary	Postoperative VAS (12 h After Surgery, Active State)	VAS pain score: 0 - completely painless, 10 - unbearable pain.	12 h after surgery
Secondary	Postoperative VAS (24 h After Surgery, Rest State)	VAS pain score: 0 - completely painless, 10 - unbearable pain.	24 h after surgery
Secondary	Postoperative VAS (24 h After Surgery, Active State)	VAS pain score: 0 - completely painless, 10 - unbearable pain.	24 h after surgery
Secondary	Postoperative VAS (48 h After Surgery, Rest State)	VAS pain score: 0 - completely painless, 10 - unbearable pain.	48 h after surgery
Secondary	Postoperative VAS (48 h After Surgery, Active State)	VAS pain score: 0 - completely painless, 10 - unbearable pain.	48 h after surgery
Secondary	Surgical Condition Scores Rated by Surgeons (Average Scores)	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.	during surgery