Diaphragm UltrasonographyPhase 4NCT05028088
Diaphragm Ultrasound to Evaluate the Antagonistic Effect of Sugammadex
A Phase 4 study testing sugammadex in people with Diaphragm Ultrasonography and Liver Dysfunction, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The use of muscle relaxants is an indispensable in the general anesthesia but is prone to accidents, which are often related to residual muscle relaxant. Therefore, how to timely and effectively eliminate the residual effect of muscle relaxants after surgery has become an urgent clinical problem. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diaphragm Ultrasonography, Liver Dysfunction, Sugammadex
- What is being tested?
- sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Age between 18 and 65 years old.
- 2.Patients scheduled for laparoscopic radical resection of liver cancer under general anesthesia.
- 3.Patients ASA classification Ⅰ-Ⅲ.
- 4.Body mass index 18.5 kg/m2 ~ 24.9 kg/m2
- 5.Able to give informed consent.
- 6.The surgical position is suitable for BIS monitoring and muscle relaxation monitoring.
Who cannot join
- 1.Patients with allergic to rocuronium and SUG.
- 2.Patients with central and peripheral nervous system diseases, such as polio, Parkinson's disease, peripheral neuropathy, etc..
- 3.Patients with neuromuscular system diseases, such as multiple sclerosis, myasthenia gravis, atrophic myotonia, etc..
- 4.Patients with diaphragm dysfunction, pneumothorax, pleural effusion, mediastinal pneumatosis.
- 5.Pregnant women or nursing mothers.
- 6.Judging by the researchers, patients with other conditions who are unsuitable for clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Yun Lin, MD, PhD., +86 02785351606, franklinyun@hust.edu.cn
Shujun Sun, +86 02785351606, sunshunjun@foxmail.com
About this study
Official title: Diaphragm Ultrasound to Evaluate the Antagonistic Effect of Sugammadex on Rocuronium After Liver Surgery in Patients With Different Liver Child-Pugh Grades
The use of muscle relaxants is an indispensable in the general anesthesia but is prone to accidents, which are often related to residual muscle relaxant. Therefore, how to timely and effectively eliminate the residual effect of muscle relaxants after surgery has become an urgent clinical problem. Rocuronium is a non-depolarizing muscle relaxant that is primarily metabolized by the liver. Patients with liver dysfunction can affect the metabolic process of rocuronium, thereby delaying the recovery of muscle relaxation. Sugammadex (SUG) is a novel specific antagonist of aminosteroid muscle relaxants, which can effectively antagonize muscle relaxants at different depths. However, whether liver dysfunction affects the antagonistic effect of SUG against rocuronium has not been reported yet. Therefore, the investigators hypothesize that with the increase of patients' liver Child-Pugh grade, the recovery time of rocuronium antagonized by the same dose of SUG after surgery will be prolonged, and the incidence of muscle relaxation residual will be increased in the short term.
Read the detailed description
Main instruments: Drager Fabius anesthesia machine, interlive vue MX600 monitor, Train-Of-Four-Watch muscle relaxation monitor, Philips IU22 Color Doppler Ultrasound Diagnostic Instrument.
Diaphragm ultrasound scan: Prior to anesthesia induction, patients will lie on the bed in a semi-recumbent (45°) position. One operator skilled in ultrasonography will identify and locate diaphragm using the hyperechoic pleural and peritoneal layers with an Philips IU22 Color Doppler Ultrasound Diagnostic Instrument.
Anesthesia method: After the patient entered the operating room, venous access will be opened in the forearm, and routine monitoring of non-invasive BP, ECG, oxygen saturation(SpO₂) and bispectral index(BIS) will be performed. During anesthesia induction, propofol 2.5mg/kg and sufentanil 5μg/kg will be injected intravenously. When the BIS value drops below 60, the muscle relaxation monitor will be calibrated. After T1 and TOF are stable, rocuronium will be injected intravenously at 0.6 mg/kg. By the time T1=0, endotracheal intubation will be given, and the respiratory parameters will need to be adjusted to volume control ventilation (VT 8-10 ml/kg, respiratory rate(RR) 12-18 times/min, and PETCO2 35-45 mmHg). During the maintenance stage of anesthesia, the pneumoperitoneum pressure will be at a low level of 8-10mmHg, propofol target-controlled infusion(TCI) will be applied to maintain the plasma concentration of 2.5-5.5 μg/mL, remifentanil TCI will be used to keep the plasma concentration of 0.5-5 ng/mL, and rocuronium will be continuously pumped intravenously with 0.3-0.6 mg/kg/h for deep muscle relaxations, with the the post-tetanic twitch count (PTC) value of 1 to 2.
Muscle relaxation monitoring: TOF-Watch SX muscle relaxation monitor is going to be adopted in our study. The investigators will standardize the electrode position of the muscle relaxation monitor. The distal electrode will be placed at the intersection of the radial edge of the ulnar flexor carpi and the proximal edge of the wrist curve, while the proximal electrode will be placed 3-6 cm away from the distal electrode. Two electrodes will put on either side of the predicted location of the ulnar nerve, which will be able to minimize the impact caused by misjudgment of the location of the nerve.
Measurement of diaphragmatic thickness: When B-mode ultrasound will be used to measure the thickness of the diaphragm, a 5-12MHz linear array ultrasound probe will be put in the left midaxillary line between the 8-10 costale, where is called the diaphragmatic zone of apposition (ZAP). In the breathing exercise, the diaphragm is relatively fixed at ZAP, and the breathing action has little influence on the movement of the diaphragm at ZAP, the diaphragm only shows systolic and diastolic changes. Therefore, the measurement of the diaphragm thickness at ZAP can truly reflect the overall thickness change of the diaphragm during the respiratory cycle. Each value will be measured three times in three consecutive breathing cycles, and the average of the nine measurements will be taken. The values of diaphragmatic thickness at the end of inspirations (DTEI) and diaphragmatic thickness at the end of expirations (DTEE) will be recorded respectively, then the change rate of diaphragmatic thickness fraction (DTF) = (DTEI - DTEE) / DTEE × 100% will be calculated. In addition, the recover rate of DTF = (pre-anesthetic DTEI - postoperative DTEI) / pre-anesthetic DTEI × 100% also will be figured out. Ultrasound measurements should be performed by two physicians with ultrasound experience. Results will be kept confidential to the investigator, who will analyze the ultrasound data when the research is over.
The infusion of anesthetic drugs should be stopped at the end of surgery, and the patients will be transferred into the Post-Anesthesia Care Unit (PACU) with endotracheal catheters and continued monitoring. When the TOF value was ≥2%, patients in each group will be given SUG (2mg/kg), respectively. The researchers will record the recovery conditions of diaphragmatic function monitored by bedside ultrasound at the immediate time,10min, 30min and 2h after extubation.
- Conditions
- Diaphragm Ultrasonography, Liver Dysfunction, Sugammadex, Rocuronium
- Being tested
- sugammadex
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugammadexDrug
Also called diaphragm ultrasonography
This study is a prospective, double-blind, low-intervention, non-randomized controlled clinical trial involving 99 patients with American Society of Anesthesiologists Ⅰ-Ⅲ, body mass index 18.5-24.9 kg/m2, who will undergo laparoscopic radical resection of liver cancer under general anesthesia in the Wuhan Union Hospital. Ultrasonography will be applied to monitor the change rate of diaphragm thickness at different time after extubation to evaluate the recovery rate of muscle relaxant, which indirectly reflects the dose-effect relationship of SUG antagonizing against rocuronium in patients with different liver Child-Pugh grades preoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Child-Pugh A | Experimental | 1. Diaphragm ultrasound scan before induction of anesthesia.
2. Anesthesia method: During anesthesia induction, propofol 2.5mg/kg and sufentanil 5μg/kg will be injected intravenously. When the BIS value drops below 60, the muscle relaxation monitor will be calibrated. After T1 and TOF are stable, rocuronium will be injected intravenously at 0.6 mg/kg. During the maintenance stage of anesthesia, the pneumoperitoneum pressure will be at a low level of 8-10mmHg, propofol TCI will be applied to maintain the plasma concentration of 2.5-5.5 μg/mL, remifentanil TCI will be used to keep the plasma concentration of 0.5-5 ng/mL, and rocuronium will be continuously pumped intravenously with 0.3-0.6 mg/kg/h for deep muscle relaxations, with the the post-tetanic twitch count (PTC) value of 1 to 2.
3. When the TOF value was ≥2%, patients in each group will be given SUG (2mg/kg).
4. Diaphragm ultrasound scan at the immediate time,10min, 30min and 2h after extubation. Receives: Drug: sugammadex |
| Child-Pugh B | Experimental | 1. Diaphragm ultrasound scan before induction of anesthesia.
2. Anesthesia method: During anesthesia induction, propofol 2.5mg/kg and sufentanil 5μg/kg will be injected intravenously. When the BIS value drops below 60, the muscle relaxation monitor will be calibrated. After T1 and TOF are stable, rocuronium will be injected intravenously at 0.6 mg/kg. During the maintenance stage of anesthesia, the pneumoperitoneum pressure will be at a low level of 8-10mmHg, propofol TCI will be applied to maintain the plasma concentration of 2.5-5.5 μg/mL, remifentanil TCI will be used to keep the plasma concentration of 0.5-5 ng/mL, and rocuronium will be continuously pumped intravenously with 0.3-0.6 mg/kg/h for deep muscle relaxations, with the the post-tetanic twitch count (PTC) value of 1 to 2.
3. When the TOF value was ≥2%, patients in each group will be given SUG (2mg/kg).
4. Diaphragm ultrasound scan at the immediate time,10min, 30min and 2h after extubation. Receives: Drug: sugammadex |
| Child-Pugh C | Experimental | 1. Diaphragm ultrasound scan before induction of anesthesia.
2. Anesthesia method: During anesthesia induction, propofol 2.5mg/kg and sufentanil 5μg/kg will be injected intravenously. When the BIS value drops below 60, the muscle relaxation monitor will be calibrated. After T1 and TOF are stable, rocuronium will be injected intravenously at 0.6 mg/kg. During the maintenance stage of anesthesia, the pneumoperitoneum pressure will be at a low level of 8-10mmHg, propofol TCI will be applied to maintain the plasma concentration of 2.5-5.5 μg/mL, remifentanil TCI will be used to keep the plasma concentration of 0.5-5 ng/mL, and rocuronium will be continuously pumped intravenously with 0.3-0.6 mg/kg/h for deep muscle relaxations, with the the post-tetanic twitch count (PTC) value of 1 to 2.
3. When the TOF value was ≥2%, patients in each group will be given SUG (2mg/kg).
4. Diaphragm ultrasound scan at the immediate time,10min, 30min and 2h after extubation. Receives: Drug: sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
the recovery rate of muscle relaxation
the incidence of residual muscle relaxation at different time points after the operation and the baseline recovery rate of the diaphragm（immediately after extubation, 10minutes, 30minutes and 2hours）
When the patients' consciousness and spontaneous breathing are restored, participants can open their eyes according to the doctor's instructions, shake hands firmly, and at the same time, participants can complete the movement of raising their head continuously for more than 5 seconds to remove the tracheal tube.
Measured: 2 hours
Secondary outcomes (4)
muscle relaxation onset time
the period from administration of rocuronium to tracheal intubation
Measured: within 3 minutes
intraoperative rocuronium dosage
The sum of the dose of rocuronium bromide used in induction and maintenance of anesthesia.
Measured: through anesthesia completion, up to 2 hours
PACU monitoring time
Total time patients are monitored in PACU after surgery.
Measured: about 2 hours
the incidence of postoperative pulmonary complications
incidence of postoperative pulmonary complications within seven days
Measured: within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start1 Jul 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Diaphragm UltrasonographyStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun Lin, MD, PhD., Principal investigator, Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028088
- Sponsor's protocol ID
- 2016Summer
- Status last verified
- Aug 2021
- First submitted
- 18 Jul 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators don not plan to make the IPD collected in this study available to other researchers.
Publications
Whittaker R, Wedell D. Review of neuromuscular blockers. Compendium. 1991 Jun;12(6):408, 410, 412 passim.
PubMed 1718602Naguib M, Magboul MM. Adverse effects of neuromuscular blockers and their antagonists. Drug Saf. 1998 Feb;18(2):99-116. doi: 10.2165/00002018-199818020-00002.
PubMed 9512917Arino-Irujo JJ, Calbet-Manueco A, De la Calle-Elguezabal PA, Velasco-Barrio JM, Lopez-Timoneda F, Ortiz-Gomez JR, Fabregat-Lopez J, Palacio-Abizanda FJ, Fornet-Ruiz I, Perez-Cajaraville J. [Neuromuscular blockade monitoring. Part 1]. Rev Esp Anestesiol Reanim. 2010 Mar;57(3):153-60. doi: 10.1016/s0034-9356(10)70190-0. Spanish.
PubMed 20422848Fuchs-Buder T, Schmartz D. [Residual neuromuscular blockade]. Anaesthesist. 2017 Jun;66(6):465-476. doi: 10.1007/s00101-017-0325-1. German.
PubMed 28573344Brull SJ, Kopman AF. Current Status of Neuromuscular Reversal and Monitoring: Challenges and Opportunities. Anesthesiology. 2017 Jan;126(1):173-190. doi: 10.1097/ALN.0000000000001409.
PubMed 27820709Murphy GS, Brull SJ. Residual neuromuscular block: lessons unlearned. Part I: definitions, incidence, and adverse physiologic effects of residual neuromuscular block. Anesth Analg. 2010 Jul;111(1):120-8. doi: 10.1213/ANE.0b013e3181da832d. Epub 2010 May 4.
PubMed 20442260Aytac I, Postaci A, Aytac B, Sacan O, Alay GH, Celik B, Kahveci K, Dikmen B. Survey of postoperative residual curarization, acute respiratory events and approach of anesthesiologists. Braz J Anesthesiol. 2016 Jan-Feb;66(1):55-62. doi: 10.1016/j.bjane.2012.06.011. Epub 2014 Apr 4.
PubMed 26768931Shay D, Wongtangman K, Eikermann M, Schaefer MS. The effects of acetylcholinesterase inhibitors on morbidity after general anesthesia and surgery. Neuropharmacology. 2020 Aug 15;173:108134. doi: 10.1016/j.neuropharm.2020.108134. Epub 2020 May 19.
PubMed 32416089Hawkins J, Khanna S, Argalious M. Sugammadex for Reversal of Neuromuscular Blockade: Uses and Limitations. Curr Pharm Des. 2019;25(19):2140-2148. doi: 10.2174/1381612825666190704101145.
PubMed 31272347Tao J, Zhang W, Yue H, Zhu G, Wu W, Gong W, Fang H, He G, Hu X, Zhao H, Liu A. Prevalence of Hepatitis B Virus Infection in Shenzhen, China, 2015-2018. Sci Rep. 2019 Sep 26;9(1):13948. doi: 10.1038/s41598-019-50173-5.
PubMed 31558731Sun Y, Sun S, Chen R, Shen J, Chen X, Lin Y, Yao S. Diaphragm ultrasonography as a monitor in assessing antagonistic effect of sugammadex on rocuronium in patients with Child-Pugh grades A and B. Front Med (Lausanne). 2024 Apr 5;11:1370021. doi: 10.3389/fmed.2024.1370021. eCollection 2024.
PubMed 38686365Sun S, Sun Y, Chen R, Yao C, Xia H, Chen X, Lin Y, Yao S. Diaphragm ultrasound to evaluate the antagonistic effect of sugammadex on rocuronium after liver surgery in patients with different liver Child-Pugh grades: study protocol for a prospective, double-blind, non-randomised controlled trial. BMJ Open. 2022 Feb 1;12(2):e052279. doi: 10.1136/bmjopen-2021-052279.
PubMed 35105573
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm Ultrasound to Evaluate the Antagonistic Effect of Sugammadex on Rocuronium After Liver Surgery in Patients With Different Liver Child-Pugh Grades
- ClinicalTrials.gov ID
- NCT05028088
- Acronym / sponsor ID
- 2016Summer
- Conditions
- Diaphragm Ultrasonography, Liver Dysfunction, Sugammadex, Rocuronium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of muscle relaxants is an indispensable in the general anesthesia but is prone to accidents, which are often related to residual muscle relaxant. Therefore, how to timely and effectively eliminate the residual effect of muscle relaxants after surgery has become an urgent clinical problem. Rocuronium is a non-depolarizing muscle relaxant that is primarily metabolized by the liver. Patients with liver dysfunction can affect the metabolic process of rocuronium, thereby delaying the recovery of muscle relaxation. Sugammadex (SUG) is a novel specific antagonist of aminosteroid muscle relaxants, which can effectively antagonize muscle relaxants at different depths. However, whether liver dysfunction affects the antagonistic effect of SUG against rocuronium has not been reported yet. Therefore, the investigators hypothesize that with the increase of patients' liver Child-Pugh grade, the recovery time of rocuronium antagonized by the same dose of SUG after surgery will be prolonged, and the incidence of muscle relaxation residual will be increased in the short term.
Detailed description
Main instruments: Drager Fabius anesthesia machine, interlive vue MX600 monitor, Train-Of-Four-Watch muscle relaxation monitor, Philips IU22 Color Doppler Ultrasound Diagnostic Instrument.
Diaphragm ultrasound scan: Prior to anesthesia induction, patients will lie on the bed in a semi-recumbent (45°) position. One operator skilled in ultrasonography will identify and locate diaphragm using the hyperechoic pleural and peritoneal layers with an Philips IU22 Color Doppler Ultrasound Diagnostic Instrument.
Anesthesia method: After the patient entered the operating room, venous access will be opened in the forearm, and routine monitoring of non-invasive BP, ECG, oxygen saturation(SpO₂) and bispectral index(BIS) will be performed. During anesthesia induction, propofol 2.5mg/kg and sufentanil 5μg/kg will be injected intravenously. When the BIS value drops below 60, the muscle relaxation monitor will be calibrated. After T1 and TOF are stable, rocuronium will be injected intravenously at 0.6 mg/kg. By the time T1=0, endotracheal intubation will be given, and the respiratory parameters will need to be adjusted to volume control ventilation (VT 8-10 ml/kg, respiratory rate(RR) 12-18 times/min, and PETCO2 35-45 mmHg). During the maintenance stage of anesthesia, the pneumoperitoneum pressure will be at a low level of 8-10mmHg, propofol target-controlled infusion(TCI) will be applied to maintain the plasma concentration of 2.5-5.5 μg/mL, remifentanil TCI will be used to keep the plasma concentration of 0.5-5 ng/mL, and rocuronium will be continuously pumped intravenously with 0.3-0.6 mg/kg/h for deep muscle relaxations, with the the post-tetanic twitch count (PTC) value of 1 to 2.
Muscle relaxation monitoring: TOF-Watch SX muscle relaxation monitor is going to be adopted in our study. The investigators will standardize the electrode position of the muscle relaxation monitor. The distal electrode will be placed at the intersection of the radial edge of the ulnar flexor carpi and the proximal edge of the wrist curve, while the proximal electrode will be placed 3-6 cm away from the distal electrode. Two electrodes will put on either side of the predicted location of the ulnar nerve, which will be able to minimize the impact caused by misjudgment of the location of the nerve.
Measurement of diaphragmatic thickness: When B-mode ultrasound will be used to measure the thickness of the diaphragm, a 5-12MHz linear array ultrasound probe will be put in the left midaxillary line between the 8-10 costale, where is called the diaphragmatic zone of apposition (ZAP). In the breathing exercise, the diaphragm is relatively fixed at ZAP, and the breathing action has little influence on the movement of the diaphragm at ZAP, the diaphragm only shows systolic and diastolic changes. Therefore, the measurement of the diaphragm thickness at ZAP can truly reflect the overall thickness change of the diaphragm during the respiratory cycle. Each value will be measured three times in three consecutive breathing cycles, and the average of the nine measurements will be taken. The values of diaphragmatic thickness at the end of inspirations (DTEI) and diaphragmatic thickness at the end of expirations (DTEE) will be recorded respectively, then the change rate of diaphragmatic thickness fraction (DTF) = (DTEI - DTEE) / DTEE × 100% will be calculated. In addition, the recover rate of DTF = (pre-anesthetic DTEI - postoperative DTEI) / pre-anesthetic DTEI × 100% also will be figured out. Ultrasound measurements should be performed by two physicians with ultrasound experience. Results will be kept confidential to the investigator, who will analyze the ultrasound data when the research is over.
The infusion of anesthetic drugs should be stopped at the end of surgery, and the patients will be transferred into the Post-Anesthesia Care Unit (PACU) with endotracheal catheters and continued monitoring. When the TOF value was ≥2%, patients in each group will be given SUG (2mg/kg), respectively. The researchers will record the recovery conditions of diaphragmatic function monitored by bedside ultrasound at the immediate time,10min, 30min and 2h after extubation.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Child-Pugh A | Experimental | Drug: sugammadex1. Diaphragm ultrasound scan before induction of anesthesia. 2. Anesthesia method: During anesthesia induction, propofol 2.5mg/kg and sufentanil 5μg/kg will be injected intravenously. When the BIS value drops below 60, the muscle relaxation monitor will be calibrated. After T1 and TOF are stable, rocuronium will be injected intravenously at 0.6 mg/kg. During the maintenance stage of anesthesia, the pneumoperitoneum pressure will be at a low level of 8-10mmHg, propofol TCI will be applied to maintain the plasma concentration of 2.5-5.5 μg/mL, remifentanil TCI will be used to keep the plasma concentration of 0.5-5 ng/mL, and rocuronium will be continuously pumped intravenously with 0.3-0.6 mg/kg/h for deep muscle relaxations, with the the post-tetanic twitch count (PTC) value of 1 to 2. 3. When the TOF value was ≥2%, patients in each group will be given SUG (2mg/kg). 4. Diaphragm ultrasound scan at the immediate time,10min, 30min and 2h after extubation. |
| Child-Pugh B | Experimental | Drug: sugammadex1. Diaphragm ultrasound scan before induction of anesthesia. 2. Anesthesia method: During anesthesia induction, propofol 2.5mg/kg and sufentanil 5μg/kg will be injected intravenously. When the BIS value drops below 60, the muscle relaxation monitor will be calibrated. After T1 and TOF are stable, rocuronium will be injected intravenously at 0.6 mg/kg. During the maintenance stage of anesthesia, the pneumoperitoneum pressure will be at a low level of 8-10mmHg, propofol TCI will be applied to maintain the plasma concentration of 2.5-5.5 μg/mL, remifentanil TCI will be used to keep the plasma concentration of 0.5-5 ng/mL, and rocuronium will be continuously pumped intravenously with 0.3-0.6 mg/kg/h for deep muscle relaxations, with the the post-tetanic twitch count (PTC) value of 1 to 2. 3. When the TOF value was ≥2%, patients in each group will be given SUG (2mg/kg). 4. Diaphragm ultrasound scan at the immediate time,10min, 30min and 2h after extubation. |
| Child-Pugh C | Experimental | Drug: sugammadex1. Diaphragm ultrasound scan before induction of anesthesia. 2. Anesthesia method: During anesthesia induction, propofol 2.5mg/kg and sufentanil 5μg/kg will be injected intravenously. When the BIS value drops below 60, the muscle relaxation monitor will be calibrated. After T1 and TOF are stable, rocuronium will be injected intravenously at 0.6 mg/kg. During the maintenance stage of anesthesia, the pneumoperitoneum pressure will be at a low level of 8-10mmHg, propofol TCI will be applied to maintain the plasma concentration of 2.5-5.5 μg/mL, remifentanil TCI will be used to keep the plasma concentration of 0.5-5 ng/mL, and rocuronium will be continuously pumped intravenously with 0.3-0.6 mg/kg/h for deep muscle relaxations, with the the post-tetanic twitch count (PTC) value of 1 to 2. 3. When the TOF value was ≥2%, patients in each group will be given SUG (2mg/kg). 4. Diaphragm ultrasound scan at the immediate time,10min, 30min and 2h after extubation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1.Age between 18 and 65 years old.
- 2.Patients scheduled for laparoscopic radical resection of liver cancer under general anesthesia.
- 3.Patients ASA classification Ⅰ-Ⅲ.
- 4.Body mass index 18.5 kg/m2 ~ 24.9 kg/m2
- 5.Able to give informed consent.
Key exclusion criteria (6 listed)
- 1.Patients with allergic to rocuronium and SUG.
- 2.Patients with central and peripheral nervous system diseases, such as polio, Parkinson's disease, peripheral neuropathy, etc..
- 3.Patients with neuromuscular system diseases, such as multiple sclerosis, myasthenia gravis, atrophic myotonia, etc..
- 4.Patients with diaphragm dysfunction, pneumothorax, pleural effusion, mediastinal pneumatosis.
- 5.Pregnant women or nursing mothers.
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 |
|---|---|---|
| sugammadexAlso: diaphragm ultrasonographyThis study is a prospective, double-blind, low-intervention, non-randomized controlled clinical trial involving 99 patients with American Society of Anesthesiologists Ⅰ-Ⅲ, body mass index 18.5-24.9 kg/m2, who will undergo laparoscopic radical resection of liver cancer under general anesthesia in the Wuhan Union Hospital. Ultrasonography will be applied to monitor the change rate of diaphragm thickness at different time after extubation to evaluate the recovery rate of muscle relaxant, which indirectly reflects the dose-effect relationship of SUG antagonizing against rocuronium in patients with different liver Child-Pugh grades preoperatively. | Drug | Child-Pugh A, Child-Pugh B, Child-Pugh C |
Primary outcome
the recovery rate of muscle relaxation
Time frame: 2 hours
the incidence of residual muscle relaxation at different time points after the operation and the baseline recovery rate of the diaphragm（immediately after extubation, 10minutes, 30minutes and 2hours） When the patients' consciousness and spontaneous breathing are restored, participants can open their eyes according to the doctor's instructions, shake hands firmly, and at the same time, participants can complete the movement of raising their head continuously for more than 5 seconds to remove the tracheal tube.
4 secondary outcomes
muscle relaxation onset time
Time frame: within 3 minutes
intraoperative rocuronium dosage
Time frame: through anesthesia completion, up to 2 hours
PACU monitoring time
Time frame: about 2 hours
the incidence of postoperative pulmonary complications
Time frame: within 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Background: PubMed 1718602Whittaker R, Wedell D. Review of neuromuscular blockers. Compendium. 1991 Jun;12(6):408, 410, 412 passim.
- Background: PubMed 9512917Naguib M, Magboul MM. Adverse effects of neuromuscular blockers and their antagonists. Drug Saf. 1998 Feb;18(2):99-116. doi: 10.2165/00002018-199818020-00002.
- Background: PubMed 20422848Arino-Irujo JJ, Calbet-Manueco A, De la Calle-Elguezabal PA, Velasco-Barrio JM, Lopez-Timoneda F, Ortiz-Gomez JR, Fabregat-Lopez J, Palacio-Abizanda FJ, Fornet-Ruiz I, Perez-Cajaraville J. [Neuromuscular blockade monitoring. Part 1]. Rev Esp Anestesiol Reanim. 2010 Mar;57(3):153-60. doi: 10.1016/s0034-9356(10)70190-0. Spanish.
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- Background: PubMed 27820709Brull SJ, Kopman AF. Current Status of Neuromuscular Reversal and Monitoring: Challenges and Opportunities. Anesthesiology. 2017 Jan;126(1):173-190. doi: 10.1097/ALN.0000000000001409.
- Background: PubMed 20442260Murphy GS, Brull SJ. Residual neuromuscular block: lessons unlearned. Part I: definitions, incidence, and adverse physiologic effects of residual neuromuscular block. Anesth Analg. 2010 Jul;111(1):120-8. doi: 10.1213/ANE.0b013e3181da832d. Epub 2010 May 4.
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- Background: PubMed 31272347Hawkins J, Khanna S, Argalious M. Sugammadex for Reversal of Neuromuscular Blockade: Uses and Limitations. Curr Pharm Des. 2019;25(19):2140-2148. doi: 10.2174/1381612825666190704101145.
- Background: PubMed 31558731Tao J, Zhang W, Yue H, Zhu G, Wu W, Gong W, Fang H, He G, Hu X, Zhao H, Liu A. Prevalence of Hepatitis B Virus Infection in Shenzhen, China, 2015-2018. Sci Rep. 2019 Sep 26;9(1):13948. doi: 10.1038/s41598-019-50173-5.
- Derived from this study: PubMed 38686365Sun Y, Sun S, Chen R, Shen J, Chen X, Lin Y, Yao S. Diaphragm ultrasonography as a monitor in assessing antagonistic effect of sugammadex on rocuronium in patients with Child-Pugh grades A and B. Front Med (Lausanne). 2024 Apr 5;11:1370021. doi: 10.3389/fmed.2024.1370021. eCollection 2024.
- Derived from this study: PubMed 35105573Sun S, Sun Y, Chen R, Yao C, Xia H, Chen X, Lin Y, Yao S. Diaphragm ultrasound to evaluate the antagonistic effect of sugammadex on rocuronium after liver surgery in patients with different liver Child-Pugh grades: study protocol for a prospective, double-blind, non-randomised controlled trial. BMJ Open. 2022 Feb 1;12(2):e052279. doi: 10.1136/bmjopen-2021-052279.
- Individual participant dataSharing planned: No. The investigators don not plan to make the IPD collected in this study available to other researchers.
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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.
Yun Lin, MD, PhD. principal investigator
Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sugammadex in people with Diaphragm Ultrasonography and Liver Dysfunction, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Sep 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Lin, MD, PhD. (+86 02785351606, franklinyun@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the recovery rate of muscle relaxation (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05028088, which also lists 12 linked publications.
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 5 Sep 2021.