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Study on the Level of Neuromuscular Blockade

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ClinicalTrials.gov Identifier: NCT03782233
Recruitment Status : Completed
First Posted : December 20, 2018
Results First Posted : September 24, 2020
Last Update Posted : September 24, 2020
Sponsor:
Collaborator:
Wu Jieping Medical Foundation
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Neuromuscular Blockade 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). 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). Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect to Gastrointestinal Barrier Function During Laparoscopic Gastrectomy With Deep vs Moderate Neuromuscular Blockade.
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: deep neuromuscular blockade group (Group D)
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).
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).

moderate neuromuscular blockade group (Group M)
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).
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 Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782233


Locations
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China, Jiangsu
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Wu Jieping Medical Foundation
  Study Documents (Full-Text)

Documents provided by The First Affiliated Hospital with Nanjing Medical University:
Informed Consent Form  [PDF] November 4, 2018

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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03782233    
Other Study ID Numbers: He Huang
First Posted: December 20, 2018    Key Record Dates
Results First Posted: September 24, 2020
Last Update Posted: September 24, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
Neuromuscular Blockade
Gastrointestinal Barrier Function
Additional relevant MeSH terms:
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Bromides
Pharmaceutical Solutions
Rocuronium
Anticonvulsants
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs