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NCT Number: NCT03782233

Study on the Level of Neuromuscular Blockade

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)

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Key information

Conditions

Neuromuscular Blockade

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Plasma Concentration of D-lactic Acid Before the Surgery

    Time frame: 1 day before the surgery

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

  2. Plasma Concentration of Diamine Oxidase (DAO) Before the Surgery

    Time frame: 1 day Before the Surgery

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

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

    Time frame: 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.

  4. Postoperative Exhaust Time

    Time frame: 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.

  5. Plasma Concentration of D-lactic Acid 24 h After the Surgery

    Time frame: 24 h after the surgery

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

  6. Plasma Concentration of Diamine Oxidase (DAO) 24 h After the Surgery

    Time frame: 24 h after the Surgery

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

  7. Relative Abundance of Intestinal Microbiota

    Time frame: 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.

  8. 16s rRNA Sequencing of Postoperative Feces

    Time frame: 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.

Secondary outcomes

  1. Duration of Surgery

    Time frame: 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

  2. Surgical Condition Scores Rated by Surgeons

    Time frame: 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.

  3. Duration of CO2 Pneumoperitoneum

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

    Time from the beginning to the end of CO2 pneumoperitoneum

  4. Duration of Postoperative Hospital Stay

    Time frame: 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

  5. Postoperative VAS (12 h After Surgery, Rest State)

    Time frame: 12 h after surgery

    VAS pain score: 0 - completely painless, 10 - unbearable pain.

  6. Postoperative VAS (12 h After Surgery, Active State)

    Time frame: 12 h after surgery

    VAS pain score: 0 - completely painless, 10 - unbearable pain.

  7. Postoperative VAS (24 h After Surgery, Rest State)

    Time frame: 24 h after surgery

    VAS pain score: 0 - completely painless, 10 - unbearable pain.

  8. Postoperative VAS (24 h After Surgery, Active State)

    Time frame: 24 h after surgery

    VAS pain score: 0 - completely painless, 10 - unbearable pain.

  9. Postoperative VAS (48 h After Surgery, Rest State)

    Time frame: 48 h after surgery

    VAS pain score: 0 - completely painless, 10 - unbearable pain.

  10. Postoperative VAS (48 h After Surgery, Active State)

    Time frame: 48 h after surgery

    VAS pain score: 0 - completely painless, 10 - unbearable pain.

  11. Surgical Condition Scores Rated by Surgeons (Average Scores)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

  • Wu Jieping Medical Foundation

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2018
Registry last updated
Sep 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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