General AnesthesiaNCT02762890
Comparison of Deep Neuromuscular Block and Moderate Neuromuscular Block on Quality of Recovery in Patients Undergoing Robotic Gastrectomy
A study testing Deep neuromuscular blockade and Moderate neuromuscular blockade in people with General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate and compare the postoperative quality of recovery between the deep neuromuscular blockade and moderate neuromuscular blockade during robotic gastrectomy. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Deep neuromuscular blockade and Moderate neuromuscular blockade
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Oct 2016to 27 Feb 2017
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients aged 19-80 years who are scheduled for robotic gastrectomy
Who cannot join
- Neuromuscular disease
- History of malignant hyperthermia
- Significant renal or hepatic dysfunction
- Allergy to sugammadex or rocuronium
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University
Seoul, 120-752
About this study
The purpose of this study is to investigate and compare the postoperative quality of recovery between the deep neuromuscular blockade and moderate neuromuscular blockade during robotic gastrectomy.
- Conditions
- General Anesthesia
- Being tested
- Deep neuromuscular blockade, Moderate neuromuscular blockade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep neuromuscular blockadeDrug
neuromuscular blockade will be performed using a continuous infusion of rocuronium. Post-tetanic count 1-2 will be maintained during surgery. After the end of surgery, sugammadex of 4 mg/kg will be administered to reverse neuromuscular blockade.
Moderate neuromuscular blockadeDrug
neuromuscular blockade will be performed using a continuous infusion of rocuronium. Train-of-four 1-2 will be maintained during surgery. After the end of surgery, sugammadex of 2 mg/kg will be administered to reverse neuromuscular blockade.
| Study group | Role | What they receive |
|---|---|---|
| Deep neuromuscular blockade | Experimental | Rocuronium will be administered continuously to achieve post-tetanic count 1-2 during surgery. Receives: Drug: Deep neuromuscular blockade |
| Moderate neuromuscular blockade | Active comparator | Rocuronium will be administered continuously to achieve Train-of-four 1-2 during surgery. Receives: Drug: Moderate neuromuscular blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative quality of recovery
The postoperative quality of recovery will be evaluated at 24 and 48 hours after the end of surgery by the investigator who are blinded to the group assignments.
Measured: within 48 hours after the end of surgery.
Secondary outcomes (4)
Surgical condition
Surgical condition will be evaluated after the end of surgery by the investigator who are blinded to the group assignments.
Measured: within 48 hours after the end of surgery
shoulder pain
shoulder pain will be evaluated after the end of surgery by the investigator who are blinded to the group assignments.
Measured: within 48 hours after the end of surgery
abdominal pain
abdominal pain will be evaluated after the end of surgery by the investigator who are blinded to the group assignments.
Measured: within 48 hours after the end of surgery
nausea and vomiting
nausea and vomiting will be evaluated after the end of surgery by the investigator who are blinded to the group assignments.
Measured: within 48 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study start6 Oct 2016
- Primary completion27 Feb 2017
- Study completion27 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762890
- Sponsor's protocol ID
- 4-2016-0206
- Status last verified
- Dec 2017
- First submitted
- 4 May 2016
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Deep Neuromuscular Block and Moderate Neuromuscular Block on Quality of Recovery in Patients Undergoing Robotic Gastrectomy
- ClinicalTrials.gov ID
- NCT02762890
- Acronym / sponsor ID
- 4-2016-0206
- Conditions
- General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 6 Oct 2016 (actual)
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 27 Feb 2017 (actual)
- First posted
- 5 May 2016 (estimated)
- 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 purpose of this study is to investigate and compare the postoperative quality of recovery between the deep neuromuscular blockade and moderate neuromuscular blockade during robotic gastrectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep neuromuscular blockade | Experimental | Drug: Deep neuromuscular blockadeRocuronium will be administered continuously to achieve post-tetanic count 1-2 during surgery. |
| Moderate neuromuscular blockade | Active comparator | Drug: Moderate neuromuscular blockadeRocuronium will be administered continuously to achieve Train-of-four 1-2 during surgery. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients aged 19-80 years who are scheduled for robotic gastrectomy
Key exclusion criteria (4 listed)
- Neuromuscular disease
- History of malignant hyperthermia
- Significant renal or hepatic dysfunction
- Allergy to sugammadex or rocuronium
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 |
|---|---|---|
| Deep neuromuscular blockadeneuromuscular blockade will be performed using a continuous infusion of rocuronium. Post-tetanic count 1-2 will be maintained during surgery. After the end of surgery, sugammadex of 4 mg/kg will be administered to reverse neuromuscular blockade. | Drug | Deep neuromuscular blockade |
| Moderate neuromuscular blockadeneuromuscular blockade will be performed using a continuous infusion of rocuronium. Train-of-four 1-2 will be maintained during surgery. After the end of surgery, sugammadex of 2 mg/kg will be administered to reverse neuromuscular blockade. | Drug | Moderate neuromuscular blockade |
Primary outcome
Postoperative quality of recovery
Time frame: within 48 hours after the end of surgery.
The postoperative quality of recovery will be evaluated at 24 and 48 hours after the end of surgery by the investigator who are blinded to the group assignments.
4 secondary outcomes
Surgical condition
Time frame: within 48 hours after the end of surgery
shoulder pain
Time frame: within 48 hours after the end of surgery
abdominal pain
Time frame: within 48 hours after the end of surgery
nausea and vomiting
Time frame: within 48 hours after the end of surgery
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 18 Dec 2017.
- Individual participant dataSharing planned: No. no plan to share data
Related trials for General Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Not yet recruiting
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
Airway Management
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep neuromuscular blockade and Moderate neuromuscular blockade in people with General Anesthesia, run by Yonsei University at 1 site in South Korea.
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 1 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: finished, as of the sponsor's last update on 18 Dec 2017. 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 South Korea. 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.
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?
Postoperative quality of recovery (time frame: within 48 hours after the end of surgery.). 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 18 Dec 2017.