SurgeryNCT04944303
The Feasibility of Sugammadex for General Anesthesia in Patients Undergoing Kidney and Pancreas Transplantation Surgery
A study testing Sugammadex and Normal saline in people with Surgery, run by Second Affiliated Hospital of Guangzhou Medical University at 2 sites in China.
Trial summary
The effectiveness and safety of sugammadex were confirmed in pancreas kidney transplatation patients for reversal of deep neuromuscular blockade induced by rocuronium.Sugmmadex can reduce the length of PACU stay. Read more about this study
- Who is it for?
- Ages 25 to 62 years
- Conditions the study is for
- Surgery
- What is being tested?
- Sugammadex and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesChina
- Study dates
- 18 Dec 2020to 21 Apr 2021
- Phase
- Interventional
- 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 25 to 62 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 25 and 62 years
- body mass index （BMI）of 18.5-24.9kg/m2
- American Society of Anesthesiologists (ASA) score from I to III.
Who cannot join
- history of allergy to narcotic drugs and other drugs
- cardiopulmonary insufficiency
- congestive heart failure
- neuromuscular disease，such as myasthenia gravis
- severe liver dysfunction
- hyperkalemia
- history of malignant hyperfever .
Trial locations and contacts
2 sites in 1 country.
China2 sites
The Second Affiliated Hospital,Guangzhou Medical University
Guangzhou, Guangdong, 510260
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510260
About this study
The effectiveness and safety of sugammadex were confirmed in pancreas kidney transplatation patients for reversal of deep neuromuscular blockade induced by rocuronium.Sugmmadex can reduce the length of PACU stay.
Read the detailed description
A randomized clinical trial was conducted between 18 December 2020 and 21 April 2021.A total of forty patients who underwent simultaneous kidney and pancreas transplantation surgery.All of the patients were randomized divided into normal saline group (Group C, n =20) and sugammadex group (Group S, n =2). Group C did not receive any neuromuscular block antagonist（NMBA). Group S received sugammadex 4 mg kg-1 at 1-2 post-tetanic counts for reversal of rocuronium NMB. The neuromuscular blockade was monitored via a peripheral nerve stimulator TOF watch SX acceleromyography. Patients received adequate doses of rocuronium to maintain an enough neuromuscular blockade during the whole surgery. Serum creatinine (CREA), blood glucose (Glu) levels were measured at T0, 8h(T1), 12h(T2), 36h(T3), 60h(T4), 84h(T5), and 108h(T6), and blood pressure (MAP), heart rate (HR), blood oxygen saturation (SpO2) and stay time in PACU were recorded.
- Conditions
- Surgery
- Being tested
- Sugammadex, Normal saline
- Keywords
- sugmmadex;, SPK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called Bridion
Sugammadex is a modified γ-cyclodextrin designed selectively to reverse the effects of the neuromuscular blocking agents (NMBAs) rocuronium and vecuronium
Normal salineDrug
Equal doseage of normal saline was injected to reverse the NMB.
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex | Active comparator | In the early group, the injection of muscle relaxant was stopped 2min the operation finish, and 4mg kg-1 of sugammadex was injected . Receives: Drug: Sugammadex; Drug: Normal saline |
| Normal Saline | Placebo comparator | the injection of muscle relaxant was stopped 2min the operation finish, and equal normal saline was injected . Receives: Drug: Sugammadex; Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recovery time of the neuromuscular blockade in both groups
Group S received sugammadex 4 mg kg-1 at 1-2 post-tetanic counts for reversal of rocuronium NMB
Measured: up to 3 months
Secondary outcomes (3)
Mean blood pressure (MAP)
MAP was measured at the time of sugammadex injection T0, 8hours after the injection(T1), 12hours after the injection(T2), 36hours after the injection(T3), 60hours after the injection(T4), 84hours after the injection(T5), and 108hours after the injection(T6)
Measured: up to 3 months
Heart rate(HR),time（T）,hour(h)
HR was measured at at the time of sugammadex injection T0, 8hours after the injection(T1), 12hours after the injection(T2), 36hours after the injection(T3), 60hours after the injection(T4), 84hours after the injection(T5), and 108hours after the injection(T6)
Measured: up to 3 months
blood oxygen saturation (SpO2),time（T）,hour(h)
SpO2 was measured at at the time of sugammadex injection T0, 8hours after the injection(T1), 12hours after the injection(T2), 36hours after the injection(T3), 60hours after the injection(T4), 84hours after the injection(T5), and 108hours after the injection(T6)
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start18 Dec 2020
- Primary completion21 Apr 2021
- Study completion21 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Guangzhou Medical UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All of the patients were randomized divided into normal saline group (Group C, n =20) and sugammadex group (Group S, n =2). Group C did not receive any neuromuscular block antagonist（NMBA)
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shikun Qian, Principal investigator, Second Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944303
- Sponsor's protocol ID
- Feasibility of Sugammadex
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Sugammadex for General Anesthesia in Patients Undergoing Kidney and Pancreas Transplantation Surgery
- ClinicalTrials.gov ID
- NCT04944303
- Acronym / sponsor ID
- Feasibility of Sugammadex
- Conditions
- Surgery
- Keywords
- sugmmadex;, SPK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 21 Apr 2021 (actual)
- First posted
- 29 Jun 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 effectiveness and safety of sugammadex were confirmed in pancreas kidney transplatation patients for reversal of deep neuromuscular blockade induced by rocuronium.Sugmmadex can reduce the length of PACU stay.
Detailed description
A randomized clinical trial was conducted between 18 December 2020 and 21 April 2021.A total of forty patients who underwent simultaneous kidney and pancreas transplantation surgery.All of the patients were randomized divided into normal saline group (Group C, n =20) and sugammadex group (Group S, n =2). Group C did not receive any neuromuscular block antagonist（NMBA). Group S received sugammadex 4 mg kg-1 at 1-2 post-tetanic counts for reversal of rocuronium NMB. The neuromuscular blockade was monitored via a peripheral nerve stimulator TOF watch SX acceleromyography. Patients received adequate doses of rocuronium to maintain an enough neuromuscular blockade during the whole surgery. Serum creatinine (CREA), blood glucose (Glu) levels were measured at T0, 8h(T1), 12h(T2), 36h(T3), 60h(T4), 84h(T5), and 108h(T6), and blood pressure (MAP), heart rate (HR), blood oxygen saturation (SpO2) and stay time in PACU were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All of the patients were randomized divided into normal saline group (Group C, n =20) and sugammadex group (Group S, n =2). Group C did not receive any neuromuscular block antagonist（NMBA)
| Arm | Type | Receives |
|---|---|---|
| Sugammadex | Active comparator | Drug: Sugammadex, Drug: Normal salineIn the early group, the injection of muscle relaxant was stopped 2min the operation finish, and 4mg kg-1 of sugammadex was injected . |
| Normal Saline | Placebo comparator | Drug: Sugammadex, Drug: Normal salinethe injection of muscle relaxant was stopped 2min the operation finish, and equal normal saline was injected . |
Who may qualify
- Ages
- 25 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 25 and 62 years
- body mass index （BMI）of 18.5-24.9kg/m2
- American Society of Anesthesiologists (ASA) score from I to III.
Key exclusion criteria (7 listed)
- history of allergy to narcotic drugs and other drugs
- cardiopulmonary insufficiency
- congestive heart failure
- neuromuscular disease，such as myasthenia gravis
- severe liver dysfunction
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: BridionSugammadex is a modified γ-cyclodextrin designed selectively to reverse the effects of the neuromuscular blocking agents (NMBAs) rocuronium and vecuronium | Drug | Normal Saline, Sugammadex |
| Normal salineEqual doseage of normal saline was injected to reverse the NMB. | Drug | Normal Saline, Sugammadex |
Primary outcome
The recovery time of the neuromuscular blockade in both groups
Time frame: up to 3 months
Group S received sugammadex 4 mg kg-1 at 1-2 post-tetanic counts for reversal of rocuronium NMB
3 secondary outcomes
Mean blood pressure (MAP)
Time frame: up to 3 months
Heart rate(HR),time（T）,hour(h)
Time frame: up to 3 months
blood oxygen saturation (SpO2),time（T）,hour(h)
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Shikun Qian principal investigator
Second Affiliated Hospital of Guangzhou Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugammadex and Normal saline in people with Surgery, run by Second Affiliated Hospital of Guangzhou Medical University at 2 sites 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The recovery time of the neuromuscular blockade in both groups (time frame: up to 3 months). 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 29 Jun 2021.