CClinicalTrials.gg
Sign In
CompletedNCT03782233Updated Sep 24, 2020Results posted

Study on the Level of Neuromuscular Blockade

An interventional study of 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 Neuromuscular Blockade, sponsored by The First Affiliated Hospital with Nanjing Medical University. Completed at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-09-24.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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)

02

Conditions studied

  • Neuromuscular Blockade

Keywords

  • Neuromuscular Blockade
  • Gastrointestinal Barrier Function
03

In context

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
83 participants (actual)

Study arms

  • 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).

  • Other
    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).

Interventions

  • DrugA 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).

  • DrugA 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).

06

What researchers measure

Primary outcomes

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

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

    Time frame: 1 day before the surgery

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

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

    Time frame: 1 day Before the Surgery

  3. 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.

    Time frame: the first time of defecation after operation

  4. 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.

    Time frame: 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

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

    Time frame: 24 h after the surgery

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

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

    Time frame: 24 h after the Surgery

  7. 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.

    Time frame: the first time of defecation after operation

  8. 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.

    Time frame: the first time of defecation after operation

Secondary outcomes

  1. Duration of Surgery

    Time from the first dose of anesthetic to the end of the surgery

    Time frame: From the first dose of anesthetic to the end of the surgery

  2. 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.

    Time frame: During operation, within 2 hours

  3. Duration of CO2 Pneumoperitoneum

    Time from the beginning to the end of CO2 pneumoperitoneum

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

  4. Duration of Postoperative Hospital Stay

    Duration from the day of surgery to the day the patient discharged from the hospital

    Time frame: from the end of surgery to the time of being discharged from hospital

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

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

    Time frame: 12 h after surgery

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

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

    Time frame: 12 h after surgery

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

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

    Time frame: 24 h after surgery

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

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

    Time frame: 24 h after surgery

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

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

    Time frame: 48 h after surgery

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

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

    Time frame: 48 h after surgery

  11. 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.

    Time frame: during surgery

07

Results

Posted Sep 24, 2020

Participant flow

Participant flow — Overall Study
MilestoneDeep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)
Started5033
Completed4631
Not completed42

Outcome measures

PrimaryPlasma Concentration of D-lactic Acid Before the Surgery

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

Time frame:
1 day before the surgery
Reported as:
Mean · ng/ml
Plasma Concentration of D-lactic Acid Before the Surgery
ng/mlDeep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)
Plasma Concentration of D-lactic Acid Before the Surgery1100.4 ± 156.61087.8 ± 146.0
PrimaryPlasma Concentration of Diamine Oxidase (DAO) Before the Surgery

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

Time frame:
1 day Before the Surgery
Reported as:
Mean · U/L
Plasma Concentration of Diamine Oxidase (DAO) Before the Surgery
U/LDeep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)
Plasma Concentration of Diamine Oxidase (DAO) Before the Surgery15.5 ± 3.016.4 ± 3.6
PrimaryTotal 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.

Time frame:
the first time of defecation after operation
Reported as:
Number · units
Total Number of Operational Taxonomic Units (OUTs) of Intestinal Microbiota
unitsDeep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)
Total Number of Operational Taxonomic Units (OUTs) of Intestinal Microbiota16951287
PrimaryPostoperative 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.

Time frame:
It is calculated from the end of the operation to the time of exhaust.
Reported as:
Mean · hour
Postoperative Exhaust Time
hourDeep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)
Postoperative Exhaust Time58.9 ± 15.970.5 ± 26.6
PrimaryPlasma Concentration of D-lactic Acid 24 h After the Surgery

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

Time frame:
24 h after the surgery
Reported as:
Mean · ng/ml
Plasma Concentration of D-lactic Acid 24 h After the Surgery
ng/mlDeep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)
Plasma Concentration of D-lactic Acid 24 h After the Surgery1230.7 ± 138.41297.5 ± 147.8
PrimaryPlasma Concentration of Diamine Oxidase (DAO) 24 h After the Surgery

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

Time frame:
24 h after the Surgery
Reported as:
Mean · U/L
Plasma Concentration of Diamine Oxidase (DAO) 24 h After the Surgery
U/LDeep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)
Plasma Concentration of Diamine Oxidase (DAO) 24 h After the Surgery18.1 ± 3.326.5 ± 4.7
PrimaryRelative 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.

Time frame:
the first time of defecation after operation
Reported as:
Median · percentage of all intestinal microbiota
Relative Abundance of Intestinal Microbiota
percentage of all intestinal microbiotaDeep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)
Class-Deltaproteobacteria0.0010483424321 ± 0.000.0010483424321 ± 0.00
Class-Flavobacteriia0 ± 00.000019780046 ± 0
Order-Desulfovibrionales0.0081493789065 ± 00.0010483424321 ± 0
Order-Flavobacteriales0 ± 00.00003956 ± 0
Family-[Tissierellaceae]0.0021362449560 ± 00.0001186802753 ± 0
Family-Fusobacteriaceae0.0005340612390 ± 00.0196020254767 ± 0
Family-Desulfovibrionaceae0.0081493789065 ± 00.0010285623862 ± 0
Family-[Weeksellaceae]0 ± 00.000019780046 ± 0
Genus-Blautia0.0097021125088 ± 00.0024725057362 ± 0
Genus-Dialister0.0002175805047 ± 00.0042724899121 ± 0
Genus-Collinsella0.0024329456444 ± 00 ± 0
Genus-Fusobacterium0.0005340612390 ± 00.0196020254767 ± 0
Genus-Bilophila0.0050636917477 ± 00.0010087823403 ± 0
Genus-Aggregatibacter0 ± 00.0007120816520 ± 0
Genus-Megasphaera0.000059340138 ± 00.0019780045889 ± 0
Genus-Neisseria0 ± 00.000019780046 ± 0
Genus-Selenomonas0 ± 00.000039560092 ± 0
Genus-Roseburia0.000019780046 ± 00 ± 0
Genus-TG50 ± 00.000019780045 ± 0
Primary16s 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.

Time frame:
the first time of defecation after operation
Reported as:
Mean · score on a scale
16s rRNA Sequencing of Postoperative Feces
score on a scaleDeep Neuromuscular Blockade Group (Group D)Moderate Neuromuscular Blockade Group (Group M)
alpha diversity - Chao1763.7 ± 183.7599.3 ± 164.0
alpha diversity - Shannon index4.93 ± 1.04.15 ± 0.9
alpha diversity - Simpson index0.9 ± 0.070.83 ± 0.1
SecondaryDuration of Surgery

Time from the first dose of anesthetic to the end of the surgery

Time frame:
From the first dose of anesthetic to the end of the surgery
Reported as:
Mean · minutes
Duration of Surgery
minutesDeep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)
Duration of Surgery155.0 ± 34.2174.6 ± 34.9
SecondarySurgical 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.

Time frame:
During operation, within 2 hours
Reported as:
Count of participants · Participants
Surgical Condition Scores Rated by Surgeons
ParticipantsDeep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)
1 point01
2 points04
3 points316
4 points97
5 points343
SecondaryDuration of CO2 Pneumoperitoneum

Time from the beginning to the end of CO2 pneumoperitoneum

Time frame:
from the beginning to the end of CO2 pneumoperitoneum
Reported as:
Mean · minute
Duration of CO2 Pneumoperitoneum
minuteDeep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)
Duration of CO2 Pneumoperitoneum132.3 ± 31.2147.0 ± 34.8
SecondaryDuration of Postoperative Hospital Stay

Duration from the day of surgery to the day the patient discharged from the hospital

Time frame:
from the end of surgery to the time of being discharged from hospital
Reported as:
Mean · days
Duration of Postoperative Hospital Stay
daysDeep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)
Duration of Postoperative Hospital Stay9.2 ± 4.09.1 ± 5.1
SecondaryPostoperative VAS (12 h After Surgery, Rest State)

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

Time frame:
12 h after surgery
Reported as:
Mean · units on a scale
Postoperative VAS (12 h After Surgery, Rest State)
units on a scaleDeep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)
Postoperative VAS (12 h After Surgery, Rest State)2.2 ± 1.42.1 ± 1.4
SecondaryPostoperative VAS (12 h After Surgery, Active State)

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

Time frame:
12 h after surgery
Reported as:
Mean · units on a scale
Postoperative VAS (12 h After Surgery, Active State)
units on a scaleDeep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)
Postoperative VAS (12 h After Surgery, Active State)3.6 ± 1.63.8 ± 1.4
SecondaryPostoperative VAS (24 h After Surgery, Rest State)

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

Time frame:
24 h after surgery
Reported as:
Mean · points
Postoperative VAS (24 h After Surgery, Rest State)
pointsDeep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)
Postoperative VAS (24 h After Surgery, Rest State)1.3 ± 1.01.5 ± 1.2
SecondaryPostoperative VAS (24 h After Surgery, Active State)

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

Time frame:
24 h after surgery
Reported as:
Mean · units on a scale
Postoperative VAS (24 h After Surgery, Active State)
units on a scaleDeep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)
Postoperative VAS (24 h After Surgery, Active State)2.7 ± 1.33.1 ± 1.4
SecondaryPostoperative VAS (48 h After Surgery, Rest State)

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

Time frame:
48 h after surgery
Reported as:
Mean · units on a scale
Postoperative VAS (48 h After Surgery, Rest State)
units on a scaleDeep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)
Postoperative VAS (48 h After Surgery, Rest State)0.4 ± 0.80.7 ± 1.0
SecondaryPostoperative VAS (48 h After Surgery, Active State)

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

Time frame:
48 h after surgery
Reported as:
Mean · units on a scale
Postoperative VAS (48 h After Surgery, Active State)
units on a scaleDeep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)
Postoperative VAS (48 h After Surgery, Active State)1.5 ± 1.11.5 ± 1.1
SecondarySurgical 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.

Time frame:
during surgery
Reported as:
Mean · units on a scale
Surgical Condition Scores Rated by Surgeons (Average Scores)
units on a scaleDeep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)
Surgical Condition Scores Rated by Surgeons (Average Scores)4.6 ± 0.63.2 ± 0.9

Adverse events

Collected over through study completion, an average of 2 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Deep Neuromuscular Blockade（Group D）0/77 (0%)0/77 (0%)0/77 (0%)
Moderate Neuromuscular Blockade (Group M)0/77 (0%)0/77 (0%)0/77 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Deep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)Total
Mean60.6 ± 10.860.0 ± 8.160.4 ± 9.8
Sex: Female, Male
Sex: Female, Male(Participants)Deep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)Total
Female17926
Male292251
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Deep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)Total
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Deep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)Total
China463177
Body mass index (BMI)
Body mass index (BMI)(kg/m^2)Deep Neuromuscular Blockade（Group D）Moderate Neuromuscular Blockade (Group M)Total
Mean23.6 ± 2.824.3 ± 2.723.92 ± 2.76
08

Study locations

1 site
  • The First Affiliated Hospital with Nanjing Medical University
    Nanjing, Jiangsu 210000, China
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 5, 2018
  • Informed consent form · Nov 4, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03782233
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Wu Jieping Medical Foundation
Responsible party
Sponsor
First posted
Dec 20, 2018
Start date
Jan 1, 2019
Primary completion
Jul 31, 2019
Completion
Dec 31, 2019
Results posted
Sep 24, 2020
Last update
Sep 24, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

The First Affiliated Hospital with Nanjing Medical University

Start the discussion