Diaphragm Ultrasound to Evaluate the Antagonistic Effect of Sugammadex

NCT05028088 | Unknown Phase 4

• 1 other identifier: 2016Summer
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diaphragm Ultrasonography; Liver Dysfunction; Sugammadex; Rocuronium

Outcome Measures

Primary Outcomes (1)

• 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.

  2 hours

Secondary Outcomes (4)

• muscle relaxation onset time

  within 3 minutes

• intraoperative rocuronium dosage

  through anesthesia completion, up to 2 hours

• PACU monitoring time

  about 2 hours

• the incidence of postoperative pulmonary complications

  within 7 days after surgery

Study Arms (3)

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.

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.

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.

Drug: sugammadex

Interventions

sugammadex DRUG

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.

Also known as: diaphragm ultrasonography

Child-Pugh A; Child-Pugh B; Child-Pugh C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years old.
• Patients scheduled for laparoscopic radical resection of liver cancer under general anesthesia.
• Patients ASA classification Ⅰ-Ⅲ.
• Body mass index 18.5 kg/m2 \~ 24.9 kg/m2
• Able to give informed consent.
• The surgical position is suitable for BIS monitoring and muscle relaxation monitoring.

You may not qualify if:

• Patients with allergic to rocuronium and SUG.
• Patients with central and peripheral nervous system diseases, such as polio, Parkinson's disease, peripheral neuropathy, etc..
• Patients with neuromuscular system diseases, such as multiple sclerosis, myasthenia gravis, atrophic myotonia, etc..
• Patients with diaphragm dysfunction, pneumothorax, pleural effusion, mediastinal pneumatosis.
• Pregnant women or nursing mothers.
• Judging by the researchers, patients with other conditions who are unsuitable for clinical trials.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

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• Sun 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.

  PMID: 38686365 DERIVED

• Sun 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.

  PMID: 35105573 DERIVED

MeSH Terms

Conditions

Liver Diseases

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Yun Lin, MD, PhD.

  Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun Lin, MD, PhD.

CONTACT

+86 02785351606; franklinyun@hust.edu.cn

Shujun Sun

CONTACT

15804066597; sunshunjun@foxmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2021
• First Posted: August 31, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)