Neuromuscular BlockadeNCT03782233
Study on the Level of Neuromuscular Blockade
A study testing 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). and 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). in people with Neuromuscular Blockade, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- 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). and 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).
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age:40-80;
- BMI < 30kg/m2；
- ASA classification:Ⅰ-Ⅲ；
- Undergoing elective laparoscopic gastrectomy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
About this study
Official title: Effect to Gastrointestinal Barrier Function During Laparoscopic Gastrectomy With Deep vs Moderate 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)
- Conditions
- Neuromuscular Blockade
- Being tested
- 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)., 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).
- Keywords
- Neuromuscular Blockade, Gastrointestinal Barrier Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentration of D-lactic Acid Before the Surgery
The level of D-lactic acid can indicate the damage to the gastrointestinal barrier .
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: the first time of defecation after operation
Secondary outcomes (11)
Duration of Surgery
Time from the first dose of anesthetic to the end of the surgery
Measured: 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.
Measured: During operation, within 2 hours
Duration of CO2 Pneumoperitoneum
Time from the beginning to the end of CO2 pneumoperitoneum
Measured: 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
Measured: from the end of surgery to the time of being discharged from hospital
Postoperative VAS (12 h After Surgery, Rest State)
VAS pain score: 0 - completely painless, 10 - unbearable pain.
Measured: 12 h after surgery
Postoperative VAS (12 h After Surgery, Active State)
VAS pain score: 0 - completely painless, 10 - unbearable pain.
Measured: 12 h after surgery
Postoperative VAS (24 h After Surgery, Rest State)
VAS pain score: 0 - completely painless, 10 - unbearable pain.
Measured: 24 h after surgery
Postoperative VAS (24 h After Surgery, Active State)
VAS pain score: 0 - completely painless, 10 - unbearable pain.
Measured: 24 h after surgery
Postoperative VAS (48 h After Surgery, Rest State)
VAS pain score: 0 - completely painless, 10 - unbearable pain.
Measured: 48 h after surgery
Postoperative VAS (48 h After Surgery, Active State)
VAS pain score: 0 - completely painless, 10 - unbearable pain.
Measured: 48 h after surgery
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.
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start1 Jan 2019
- Primary completion31 Jul 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782233
- Sponsor's protocol ID
- He Huang
- Status last verified
- Sep 2020
- First submitted
- 11 Dec 2018
- Last updated
- 24 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect to Gastrointestinal Barrier Function During Laparoscopic Gastrectomy With Deep vs Moderate Neuromuscular Blockade.
- ClinicalTrials.gov ID
- NCT03782233
- Acronym / sponsor ID
- He Huang
- Conditions
- Neuromuscular Blockade
- Keywords
- Neuromuscular Blockade, Gastrointestinal Barrier Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Posted 24 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep neuromuscular blockade group (Group D) | Experimental | 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).Patients undergoing elective laparoscopic surgery for gastrectomy will be randomized to receive deep neuromuscular blockade (post-tetanic count = 1-2) using high dose rocuronium. |
| moderate neuromuscular blockade group (Group M) | Other | 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).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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age:40-80;
- BMI < 30kg/m2；
- ASA classification:Ⅰ-Ⅲ；
- Undergoing elective laparoscopic gastrectomy.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Drug | 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).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). | Drug | moderate neuromuscular blockade group (Group M) |
Primary outcome
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 .
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 .
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.
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.
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 .
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 .
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.
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.
11 secondary outcomes
Duration of Surgery
Time frame: From the first dose of anesthetic to the end of the surgery
Surgical Condition Scores Rated by Surgeons
Time frame: During operation, within 2 hours
Duration of CO2 Pneumoperitoneum
Time frame: from the beginning to the end of CO2 pneumoperitoneum
Duration of Postoperative Hospital Stay
Time frame: from the end of surgery to the time of being discharged from hospital
Postoperative VAS (12 h After Surgery, Rest State)
Time frame: 12 h after surgery
Postoperative VAS (12 h After Surgery, Active State)
Time frame: 12 h after surgery
Postoperative VAS (24 h After Surgery, Rest State)
Time frame: 24 h after surgery
Postoperative VAS (24 h After Surgery, Active State)
Time frame: 24 h after surgery
Postoperative VAS (48 h After Surgery, Rest State)
Time frame: 48 h after surgery
Postoperative VAS (48 h After Surgery, Active State)
Time frame: 48 h after surgery
Surgical Condition Scores Rated by Surgeons (Average Scores)
Time frame: during surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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). and 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). in people with Neuromuscular Blockade, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Concentration of D-lactic Acid Before the Surgery (time frame: 1 day before the surgery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.