Trial Outcomes & Findings for Study on the Level of Neuromuscular Blockade (NCT NCT03782233)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

83 participants

Primary outcome timeframe

1 day before the surgery

Results posted on

2020-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	Deep Neuromuscular Blockade（Group D） 50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).	Moderate Neuromuscular Blockade (Group M) 33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).
Overall Study STARTED	50	33
Overall Study COMPLETED	46	31
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Deep Neuromuscular Blockade（Group D） n=46 Participants 50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).	Moderate Neuromuscular Blockade (Group M) n=31 Participants 33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).	Total n=77 Participants Total of all reporting groups
Age, Continuous	60.6 years STANDARD_DEVIATION 10.8 • n=46 Participants	60.0 years STANDARD_DEVIATION 8.1 • n=31 Participants	60.4 years STANDARD_DEVIATION 9.8 • n=77 Participants
Sex: Female, Male Female	17 Participants n=46 Participants	9 Participants n=31 Participants	26 Participants n=77 Participants
Sex: Female, Male Male	29 Participants n=46 Participants	22 Participants n=31 Participants	51 Participants n=77 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment China	46 participants n=46 Participants	31 participants n=31 Participants	77 participants n=77 Participants
Body mass index (BMI)	23.6 kg/m^2 STANDARD_DEVIATION 2.8 • n=46 Participants	24.3 kg/m^2 STANDARD_DEVIATION 2.7 • n=31 Participants	23.92 kg/m^2 STANDARD_DEVIATION 2.76 • n=77 Participants

PRIMARY outcome

Timeframe: 1 day before the surgery

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

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Blockade Group (Group M) n=31 Participants 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. 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).	Deep Neuromuscular Blockade（Group D） n=46 Participants 50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).
Plasma Concentration of D-lactic Acid Before the Surgery	1087.8 ng/ml Standard Deviation 146.0	1100.4 ng/ml Standard Deviation 156.6

PRIMARY outcome

Timeframe: 1 day Before the Surgery

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

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Blockade Group (Group M) n=31 Participants 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. 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).	Deep Neuromuscular Blockade（Group D） n=46 Participants 50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).
Plasma Concentration of Diamine Oxidase (DAO) Before the Surgery	16.4 U/L Standard Deviation 3.6	15.5 U/L Standard Deviation 3.0

PRIMARY outcome

Timeframe: the first time of defecation after operation

Population: There were only 8 patients in group D and 5 patients in group M defecating before discharged from hospital.

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.

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Blockade Group (Group M) n=5 Participants 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. 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).	Deep Neuromuscular Blockade（Group D） n=8 Participants 50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).
Total Number of Operational Taxonomic Units (OUTs) of Intestinal Microbiota	1287 units	1695 units

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Blockade Group (Group M) n=31 Participants 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. 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).	Deep Neuromuscular Blockade（Group D） n=46 Participants 50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).
Postoperative Exhaust Time	70.5 hour Standard Deviation 26.6	58.9 hour Standard Deviation 15.9

PRIMARY outcome

Timeframe: 24 h after the surgery

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

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Blockade Group (Group M) n=31 Participants 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. 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).	Deep Neuromuscular Blockade（Group D） n=46 Participants 50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).
Plasma Concentration of D-lactic Acid 24 h After the Surgery	1297.5 ng/ml Standard Deviation 147.8	1230.7 ng/ml Standard Deviation 138.4

PRIMARY outcome

Timeframe: 24 h after the Surgery

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

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Blockade Group (Group M) n=31 Participants 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. 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).	Deep Neuromuscular Blockade（Group D） n=46 Participants 50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).
Plasma Concentration of Diamine Oxidase (DAO) 24 h After the Surgery	26.5 U/L Standard Deviation 4.7	18.1 U/L Standard Deviation 3.3

PRIMARY outcome

Timeframe: the first time of defecation after operation

Population: There were 8 patients group D and 5 patients in group M defecating before being discharged from the hospital.

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.

Outcome measures

PRIMARY outcome

Timeframe: the first time of defecation after operation

Population: There were 8 patients group D and 5 patients in group M defecating before being discharged from the hospital. There are so much basic data about the 16s rRNA sequencing that we can not upload them. The amount of work was formidable. You may contact with me if necessary for all the sequencing data.

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.

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Blockade Group (Group M) n=5 Participants 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. 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).	Deep Neuromuscular Blockade（Group D） n=8 Participants 50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).
16s rRNA Sequencing of Postoperative Feces alpha diversity - Chao1	599.3 score on a scale Standard Deviation 164.0	763.7 score on a scale Standard Deviation 183.7
16s rRNA Sequencing of Postoperative Feces alpha diversity - Shannon index	4.15 score on a scale Standard Deviation 0.9	4.93 score on a scale Standard Deviation 1.0
16s rRNA Sequencing of Postoperative Feces alpha diversity - Simpson index	0.83 score on a scale Standard Deviation 0.1	0.9 score on a scale Standard Deviation 0.07

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Blockade Group (Group M) n=31 Participants 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. 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).	Deep Neuromuscular Blockade（Group D） n=46 Participants 50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).
Duration of Surgery	174.6 minutes Standard Deviation 34.9	155.0 minutes Standard Deviation 34.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Blockade Group (Group M) n=31 Participants 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. 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).	Deep Neuromuscular Blockade（Group D） n=46 Participants 50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).
Surgical Condition Scores Rated by Surgeons 1 point	1 Participants	0 Participants
Surgical Condition Scores Rated by Surgeons 2 points	4 Participants	0 Participants
Surgical Condition Scores Rated by Surgeons 3 points	16 Participants	3 Participants
Surgical Condition Scores Rated by Surgeons 4 points	7 Participants	9 Participants
Surgical Condition Scores Rated by Surgeons 5 points	3 Participants	34 Participants

SECONDARY outcome

Timeframe: from the beginning to the end of CO2 pneumoperitoneum

Time from the beginning to the end of CO2 pneumoperitoneum

Outcome measures

Outcome measures
Measure	Moderate Neuromuscular Blockade Group (Group M) n=31 Participants 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. 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).	Deep Neuromuscular Blockade（Group D） n=46 Participants 50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).
Duration of CO2 Pneumoperitoneum	147.0 minute Standard Deviation 34.8	132.3 minute Standard Deviation 31.2

SECONDARY outcome

Timeframe: 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