Laparoscopic Bariatric SurgeryNCT06678451
Sugammadex on Laparoscopic Bariatric Surgery
A study testing Sugammadex and Neostigmine in people with Laparoscopic Bariatric Surgery and Sugammadex, run by Shanxi Bethune Hospital.
Trial summary
Laparoscopic bariatric surgery has been recognized as the most effective treatment for obesity and related metabolic diseases. Because obesity patients often associated with sleep apnea syndrome or obesity hypoventilation syndrome, combined with the residual effect of muscle relaxants during the operation is easy to… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Laparoscopic Bariatric Surgery, Sugammadex
- What is being tested?
- Sugammadex and Neostigmine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50 years
- Body Mass Index (BMI) ≥ 40kg/m²
- American Society of Anesthesiologists (ASA) grade I to III classification
- NYHA cardiac function grade I - II
Who cannot join
- Patients with neuromuscular disease or respiratory system disease
- Patients with severe abnormal liver and renal function
- Perioperative use of drugs known to interact with rocuronium
- Patients with unstable mental illness or refusal to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Sugammadex on Quality of Recovery Following Laparoscopic Bariatric Surgery
Laparoscopic bariatric surgery has been recognized as the most effective treatment for obesity and related metabolic diseases. Because obesity patients often associated with sleep apnea syndrome or obesity hypoventilation syndrome, combined with the residual effect of muscle relaxants during the operation is easy to lead to respiratory obstruction and respiratory insufficiency, and hypoxemia and carbon dioxide retention are easy to occur after surgery, Post-extubation is prone to upper respiratory tract obstruction such as retrolingual fall, thus increase the risk of perioperative respiratory complications. Therefore, it is very important to achieve a rapid and effective antagonistic muscle relaxant effect, reduce the postoperative muscle relaxation residue, and maintain the patency of the patient's airway.
Compared with the traditional cholinesterase inhibitor neostigmine, sugammadex is a specific antagonist of novel aminosteroid muscle blockers, which rapidly reverses moderate and deep neuromuscular block by combining with rocuronium or vecuronium 1:1,without compatibility with due to its no effect on muscarinic receptors or plasma cholinesterase. The absence of cholinergic and cardiovascular effects during awakening from anesthesia would be significant benefit for patients with cardiovascular or respiratory diseases.
The pharmacological effect of sugammadex is its ability to form a tight 1:1 complex with amino steroid neuromuscular blockers, which causes a lower plasma concentration of free neuromuscular blockers and promotes the transfer of neuromuscular blockers from the peripheral compartment (including the neuromuscular junction) to the plasma gradient. A meta-analysis by Vaghiri et al showed that reversal of neuromuscular block by sugammadex accelerated postoperative recovery of intestinal peristalsis in patients undergoing colorectal surgery compared with acetylcholinesterase inhibitors. Deljou et al confirmed that reversal of neuromuscular blockade with sugammadex shortened the time to first postoperative defecation in patients compared with neostigmine / glononium bromide. The study will investigate the effect of sugammadex in patients undergoing laparoscopic bariatric surgery.
Read the detailed description
- Study purpose This study intends to compare the neuromuscular block effects of sugammadex or neostigmine against rocuronium after laparoscopic bariatric surgery, investigate the effect of sugammadex reversing neuromuscular block on the recovery quality of laparoscopic bariatric surgery by observing the time from muscle relaxation antagonism to TOF ratio ≥0.9, tracheal extubation time, postoperative Richmond Agitation-Sedation Scale, postoperative Visual Analogue Scale and opioid consumption, postoperative respiratory and gastrointestinal function, postoperative QoR-15 recovery quality score and other indicators, to provide clinical data for rapid recovery of laparoscopic bariatric surgery.
- Study design 2.1. Type of the study The research is a single-center, double-blind, randomized-controlled clinical trial. 2.2 Sample size calculation The estimated sample size was calculated using SPSS Statistics, version 26.0 ((IBM Corp), and this was based on our preliminary study. 2.3 Randomization and blinding Patients were randomly assigned in a 1:1 ratio into 2 groups, the neostigmine group or the sugammadex group via centrally computer-generated group randomization. Immediately after the surgery, a sealed opaque envelope containing the patient group assignment was opened by an experienced anesthesiologist in charge. When T2 appeared, the sugammadex group was given 2mg/kg of sugammadex intravenously (adjusted body weight), the neostigmine group was given 0.04mg/kg of neostigmine + 0.02mg/kg of atropine intravenously (adjusted body weight). Participants in the neostigmine group and sugammadex group were kept blinded to their group assignment. This study involved researchers who conducted the postoperative follow-up and evaluation (blinded) and researchers who administered the treatment (unblinded). The unblinded researchers who administered the interventions were not involved in the evaluation of the postoperative outcomes.
- Quality control All research data, both in paper and electronic formats, will be kept for at least 5 years. If readers have any questions after the article\'s publication, they may contact the corresponding author for access to the original data. Patient information will remain anonymous, including name, ID number and telephone number. All data related to enrolled patients collected during the study period of this project will be archived and safeguarded, and all study members and study sponsors are asked to keep subject information confidential. The study protocol will be reviewed and revised by statistical experts. Investigators will adhere to pre-defined standard operating procedures, encompassing patient screening, follow-up standardization, result assessment, and data management. The Ethics Committee of Shanxi Bethune Hospital will review the trial every six months.
- Statistical analysis
Statistical analysis was performed using SPSS Statistics, version 26.0. Normally distributed continuous variables were presented as mean (SD) values, and intergroup comparisons used independent-sample t-test. Nonnormally distributed variables were presented as median (IQR) values, and intergroup comparisons were determined using the Mann-Whitney test. Categorical variables were expressed as frequencies and percentages, and these were compared using either the χ2 test or the Fisher exact test. A P\<0.05 was considered to be statistically significant.
- Conditions
- Laparoscopic Bariatric Surgery, Sugammadex
- Being tested
- Sugammadex, Neostigmine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
When T2 appeared, the sugammadex group was given 2mg/kg of sugammadex intravenously (adjusted body weight), the neostigmine group was given 0.04mg/kg of neostigmine + 0.02mg/kg of atropine intravenously (adjusted body weight).
NeostigmineDrug
When T2 appeared, the neostigmine group was given 0.04mg/kg of neostigmine + 0.02mg/kg of atropine intravenously (adjusted body weight).
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex group | Experimental | When T2 appeared, the sugammadex group was given 2mg/kg of sugammadex intravenously (adjusted body weight) Receives: Drug: Sugammadex |
| Neostigmine group | Active comparator | When T2 appeared, the neostigmine group was given 0.04mg/kg of neostigmine + 0.02mg/kg of atropine intravenously (adjusted body weight). Receives: Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative muscle relaxation recovery
Postoperative muscle relaxation recovery, measured using the time of train-of-four stimulation (TOF) ratio ≥0.9
Measured: After injection of muscle relaxation antagonist, an average of 30 minutes
Secondary outcomes (8)
Postoperative pain scores at rest and during coughing
Pain scores, measured using the Visual Analog Scale(0 points indicated no pain, a score <4 indicated mild pain; a 4-7 score indicated moderate pain, a score >7 points indicated severe pain, and a score of 10 indicated unbearably severe pain)
Measured: 1, 6, 12, 24 and 48 hours after surgery
Postoperative opioid consumption
The total amount of sufentanil used in the PCA pump within the initial 48 hours postoperatively
Measured: 48 hours after surgery
Postoperative remedial analgesia rate
The rate of remedial analgesia 48 hours postoperatively
Measured: 48 hours after surgery
Postoperative arterial blood gas
PaO2 and PaCO2, measured using the blood-gas analyzer
Measured: 12, 24 and 48 hours after surgery
Postoperative pulmonary function
Forced expiratory volume in the first second/forced vital capacity (FEV1/FVC) and interstitial forced expiratory flow 25%-75%(FEF25%-75%) are measured using the pulmonary function testing equipment.
Measured: 12, 24 and 48 hours after surgery
Postoperative gastrointestinal function
I-FEED scores(an I-FEED scores of 0-2 indicates postoperative gastrointestinal normality, 3-5 indicates postoperative gastrointestinal intolerance, and ≥6 indicates postoperative gastrointestinal dysfunction)
Measured: 12, 24 and 48 hours after surgery
The time of first exhaust and defecation
The time of first flatus and defecation within 48h after operation was measured by hour
Measured: 48 hours after surgery
Postoperative recovery quality
Quality of recovery, measured using the 15-item Quality of Recovery questionnaire (QoR-15), It ranges from 0 to 150, with a higher score indicating a better quality of recovery
Measured: 24 and 48 hours after suegery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study startDec 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Bariatric SurgeryStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Bethune Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian-Wen Zhang, MD, Principal investigator, Shanxi Bethune Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678451
- Sponsor's protocol ID
- YXLL-2024-195
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sugammadex on Quality of Recovery Following Laparoscopic Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06678451
- Acronym / sponsor ID
- YXLL-2024-195
- Conditions
- Laparoscopic Bariatric Surgery, Sugammadex
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanxi Bethune HospitalUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 7 Nov 2024 (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.
Laparoscopic bariatric surgery has been recognized as the most effective treatment for obesity and related metabolic diseases. Because obesity patients often associated with sleep apnea syndrome or obesity hypoventilation syndrome, combined with the residual effect of muscle relaxants during the operation is easy to lead to respiratory obstruction and respiratory insufficiency, and hypoxemia and carbon dioxide retention are easy to occur after surgery, Post-extubation is prone to upper respiratory tract obstruction such as retrolingual fall, thus increase the risk of perioperative respiratory complications. Therefore, it is very important to achieve a rapid and effective antagonistic muscle relaxant effect, reduce the postoperative muscle relaxation residue, and maintain the patency of the patient's airway.
Compared with the traditional cholinesterase inhibitor neostigmine, sugammadex is a specific antagonist of novel aminosteroid muscle blockers, which rapidly reverses moderate and deep neuromuscular block by combining with rocuronium or vecuronium 1:1,without compatibility with due to its no effect on muscarinic receptors or plasma cholinesterase. The absence of cholinergic and cardiovascular effects during awakening from anesthesia would be significant benefit for patients with cardiovascular or respiratory diseases.
The pharmacological effect of sugammadex is its ability to form a tight 1:1 complex with amino steroid neuromuscular blockers, which causes a lower plasma concentration of free neuromuscular blockers and promotes the transfer of neuromuscular blockers from the peripheral compartment (including the neuromuscular junction) to the plasma gradient. A meta-analysis by Vaghiri et al showed that reversal of neuromuscular block by sugammadex accelerated postoperative recovery of intestinal peristalsis in patients undergoing colorectal surgery compared with acetylcholinesterase inhibitors. Deljou et al confirmed that reversal of neuromuscular blockade with sugammadex shortened the time to first postoperative defecation in patients compared with neostigmine / glononium bromide. The study will investigate the effect of sugammadex in patients undergoing laparoscopic bariatric surgery.
Detailed description
- Study purpose This study intends to compare the neuromuscular block effects of sugammadex or neostigmine against rocuronium after laparoscopic bariatric surgery, investigate the effect of sugammadex reversing neuromuscular block on the recovery quality of laparoscopic bariatric surgery by observing the time from muscle relaxation antagonism to TOF ratio ≥0.9, tracheal extubation time, postoperative Richmond Agitation-Sedation Scale, postoperative Visual Analogue Scale and opioid consumption, postoperative respiratory and gastrointestinal function, postoperative QoR-15 recovery quality score and other indicators, to provide clinical data for rapid recovery of laparoscopic bariatric surgery.
- Study design 2.1. Type of the study The research is a single-center, double-blind, randomized-controlled clinical trial. 2.2 Sample size calculation The estimated sample size was calculated using SPSS Statistics, version 26.0 ((IBM Corp), and this was based on our preliminary study. 2.3 Randomization and blinding Patients were randomly assigned in a 1:1 ratio into 2 groups, the neostigmine group or the sugammadex group via centrally computer-generated group randomization. Immediately after the surgery, a sealed opaque envelope containing the patient group assignment was opened by an experienced anesthesiologist in charge. When T2 appeared, the sugammadex group was given 2mg/kg of sugammadex intravenously (adjusted body weight), the neostigmine group was given 0.04mg/kg of neostigmine + 0.02mg/kg of atropine intravenously (adjusted body weight). Participants in the neostigmine group and sugammadex group were kept blinded to their group assignment. This study involved researchers who conducted the postoperative follow-up and evaluation (blinded) and researchers who administered the treatment (unblinded). The unblinded researchers who administered the interventions were not involved in the evaluation of the postoperative outcomes.
- Quality control All research data, both in paper and electronic formats, will be kept for at least 5 years. If readers have any questions after the article\'s publication, they may contact the corresponding author for access to the original data. Patient information will remain anonymous, including name, ID number and telephone number. All data related to enrolled patients collected during the study period of this project will be archived and safeguarded, and all study members and study sponsors are asked to keep subject information confidential. The study protocol will be reviewed and revised by statistical experts. Investigators will adhere to pre-defined standard operating procedures, encompassing patient screening, follow-up standardization, result assessment, and data management. The Ethics Committee of Shanxi Bethune Hospital will review the trial every six months.
- Statistical analysis
Statistical analysis was performed using SPSS Statistics, version 26.0. Normally distributed continuous variables were presented as mean (SD) values, and intergroup comparisons used independent-sample t-test. Nonnormally distributed variables were presented as median (IQR) values, and intergroup comparisons were determined using the Mann-Whitney test. Categorical variables were expressed as frequencies and percentages, and these were compared using either the χ2 test or the Fisher exact test. A P\<0.05 was considered to be statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex group | Experimental | Drug: SugammadexWhen T2 appeared, the sugammadex group was given 2mg/kg of sugammadex intravenously (adjusted body weight) |
| Neostigmine group | Active comparator | Drug: NeostigmineWhen T2 appeared, the neostigmine group was given 0.04mg/kg of neostigmine + 0.02mg/kg of atropine intravenously (adjusted body weight). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-50 years
- Body Mass Index (BMI) ≥ 40kg/m²
- American Society of Anesthesiologists (ASA) grade I to III classification
- NYHA cardiac function grade I - II
Key exclusion criteria (4 listed)
- Patients with neuromuscular disease or respiratory system disease
- Patients with severe abnormal liver and renal function
- Perioperative use of drugs known to interact with rocuronium
- Patients with unstable mental illness or refusal to participate
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 |
|---|---|---|
| SugammadexWhen T2 appeared, the sugammadex group was given 2mg/kg of sugammadex intravenously (adjusted body weight), the neostigmine group was given 0.04mg/kg of neostigmine + 0.02mg/kg of atropine intravenously (adjusted body weight). | Drug | Sugammadex group |
| NeostigmineWhen T2 appeared, the neostigmine group was given 0.04mg/kg of neostigmine + 0.02mg/kg of atropine intravenously (adjusted body weight). | Drug | Neostigmine group |
Primary outcome
Postoperative muscle relaxation recovery
Time frame: After injection of muscle relaxation antagonist, an average of 30 minutes
Postoperative muscle relaxation recovery, measured using the time of train-of-four stimulation (TOF) ratio ≥0.9
8 secondary outcomes
Postoperative pain scores at rest and during coughing
Time frame: 1, 6, 12, 24 and 48 hours after surgery
Postoperative opioid consumption
Time frame: 48 hours after surgery
Postoperative remedial analgesia rate
Time frame: 48 hours after surgery
Postoperative arterial blood gas
Time frame: 12, 24 and 48 hours after surgery
Postoperative pulmonary function
Time frame: 12, 24 and 48 hours after surgery
Postoperative gastrointestinal function
Time frame: 12, 24 and 48 hours after surgery
The time of first exhaust and defecation
Time frame: 48 hours after surgery
Postoperative recovery quality
Time frame: 24 and 48 hours after suegery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
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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.
Jian-Wen Zhang, MD principal investigator
Shanxi Bethune Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Sugammadex and Neostigmine in people with Laparoscopic Bariatric Surgery and Sugammadex, run by Shanxi Bethune Hospital.
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 4 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: opening soon, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian-Wen Zhang, MD (+86 13994299284, zjw030001@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative muscle relaxation recovery (time frame: After injection of muscle relaxation antagonist, an average of 30 minutes). 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 7 Nov 2024.