Study on the Level of Neuromuscular Blockade

NCT03782233 | Completed Results DMC

• 1 other identifier: He Huang
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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)

Conditions

Neuromuscular Blockade

Keywords

Neuromuscular Blockade; Gastrointestinal Barrier Function

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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.

• 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

• 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

• 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

• 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 Outcomes (11)

• Duration of Surgery

  From the first dose of anesthetic to the end of the surgery

• Surgical Condition Scores Rated by Surgeons

  During operation, within 2 hours

• Duration of CO2 Pneumoperitoneum

  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

• Postoperative VAS (12 h After Surgery, Rest State)

  12 h after surgery

Study Arms (2)

deep neuromuscular blockade group (Group D)

EXPERIMENTAL

Patients undergoing elective laparoscopic surgery for gastrectomy will be randomized to receive deep neuromuscular blockade (post-tetanic count = 1-2) using high dose rocuronium.

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).

moderate neuromuscular blockade group (Group M)

OTHER

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.

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).

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).

deep neuromuscular blockade group (Group D)

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).

moderate neuromuscular blockade group (Group M)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Wu Jieping Medical Foundation: collaborator

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

Results Point of Contact

• Title: Dr. He Huang
• Organization: The First Affiliated Hospital of Nanjing Medical University

hh19871117@126.com

13852476684

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 20, 2018
• Study Start: January 1, 2019
• Primary Completion: July 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 24, 2020
• Results First Posted: September 24, 2020

Record last verified: 2020-09

Locations

CN (1)