LaparoscopyNCT03890406
The Effect of Deep Neuromuscular Blockade on Requirement of Intravenous Anesthetic Agent
A study testing Rocuronium: PTC(Post-tetanic count) 1~2 and Rocuronium: TOF(Train-of-four) 1~2 in people with Laparoscopy and General Anesthesia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Recently, deep neuromuscular blockade during general anesthesia has been studied by many authors regarding various effects upon patients' outcomes and surgical conditions. We believe deep neuromuscular blockade can be especially beneficial in laparoscopic surgery, because it can expand surgical space and prevent… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopy, General Anesthesia, Neuromuscular Blockade
- What is being tested?
- Rocuronium: PTC(Post-tetanic count) 1~2 and Rocuronium: TOF(Train-of-four) 1~2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2019to 31 Mar 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective laparoscopic colorectal resection due to benign or malignant neoplasm of colon or rectum
- ASA class I or II
Who cannot join
- Patients receiving medications known to have drug-drug interaction with neuromuscular blocking agents
- Patients who have significantly impaired cardiac, pulmonary, hepatic, renal function
- Patients who are pregnant
- Patients who are known to have hypersensitivity to the anesthetic/analgesic/neuromuscular blocking agents which are going to be used in the study
- BMI < 18.5 or > 35.0 kg/m2
- Patients with previous history of open abdominal surgery
- Patients with previous history of malignant hyperthermia
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: The Effect of Deep Neuromuscular Blockade on Requirement of Intravenous Anesthetic Agent During Laparoscopic Colorectal Surgery
Recently, deep neuromuscular blockade during general anesthesia has been studied by many authors regarding various effects upon patients' outcomes and surgical conditions. We believe deep neuromuscular blockade can be especially beneficial in laparoscopic surgery, because it can expand surgical space and prevent patients' minute movements that can disturb precise operations. In clinical situations, anesthetists tend to compensate the insufficiency of neuromuscular blockade by increasing the dose of other anesthetic agents, which can prolong patients' recovery time and impair the surgical condition. In this study, we plan to divide the patients into 2 groups according to the depth of neuromuscular blockade, and compare the dose of anesthetic agent used to maintain surgical condition.
Read the detailed description
Patients undergoing elective laparoscopic colorectal surgery are going to be recruited and divided into 2 groups: Group D will receive deep neuromuscular blockade, and Group M will receive moderate neuromuscular blockade using continuous infusion of rocuronium. Acceleromyography(TOF-watch SX) will be used to monitor the depth of blockade. In both groups, the anesthesia will be maintained with TIVA(total intra-venous anesthesia) including continuous target-controlled infusion of propofol and remifentanil. During the surgery, the number of patient movement and restoration of self respiration will be recorded. At the end of anesthesia, the dose of propofol and remifentanil used will be assessed and compared between the groups. Also, the satisfaction score of surgeons regarding the surgical condition, the anesthesia time, the operation time will be documented. After the patients are discharged, their charts are going to be reviewed and whether any pulmonary or surgical complications occurred will be documented.
- Conditions
- Laparoscopy, General Anesthesia, Neuromuscular Blockade
- Being tested
- Rocuronium: PTC(Post-tetanic count) 1~2, Rocuronium: TOF(Train-of-four) 1~2
- Keywords
- Deep neuromuscular blockade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium: PTC(Post-tetanic count) 1~2Drug
Also called Deep block
Deep neuromuscular blockade will be maintained using continuous infusion of rocuronium.
Rocuronium: TOF(Train-of-four) 1~2Drug
Also called Moderate block
Moderate neuromuscular blockade will be maintained using continuous infusion of rocuronium.
| Study group | Role | What they receive |
|---|---|---|
| Group D | Experimental | Deep neuromuscular blockade Receives: Drug: Rocuronium: PTC(Post-tetanic count) 1~2 |
| Group M | Active comparator | Moderate neuromuscular blockade Receives: Drug: Rocuronium: TOF(Train-of-four) 1~2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of propofol
the amount of propofol used (mg/kg)
Measured: intraoperative (from starting of anesthesia to end of anesthesia)
Secondary outcomes (4)
Dosage of remifentanil
the amount of remifentanil used (mcg/kg)
Measured: intraoperative (from starting of anesthesia to end of anesthesia)
Patient movement
the observed number of patient movement during the surgery
Measured: intraoperative (from tracheal intubation to injection of neuromuscular reversal agent)
Patient self respiration
the observed number of restoration of self breathing during the surgery (ex. EtCO2 notching)
Measured: intraoperative (from tracheal intubation to injection of neuromuscular reversal agent)
Surgical condition score
the 5-point satisfaction score of surgeon regarding surgical conditions
Measured: assessed at the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Apr 2019
- Primary completion31 Dec 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LaparoscopyStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BON WOOK KOO, Seoul National University Bundang Hospital
- Investigators
- Ah Young Oh, MD, PhD, Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890406
- Sponsor's protocol ID
- DEEPTIVA
- Status last verified
- Jun 2020
- First submitted
- 25 Mar 2019
- Last updated
- 30 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nam SW, Oh AY, Koo BW, Kim BY, Han J, Chung SH. Effects of depth of neuromuscular blockade on the BIS-guided propofol requirement: A randomized controlled trial. Medicine (Baltimore). 2021 Jul 23;100(29):e26576. doi: 10.1097/MD.0000000000026576.
PubMed 34398011
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Deep Neuromuscular Blockade on Requirement of Intravenous Anesthetic Agent During Laparoscopic Colorectal Surgery
- ClinicalTrials.gov ID
- NCT03890406
- Acronym / sponsor ID
- DEEPTIVA
- Conditions
- Laparoscopy, General Anesthesia, Neuromuscular Blockade
- Keywords
- Deep neuromuscular blockade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 26 Mar 2019 (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.
Recently, deep neuromuscular blockade during general anesthesia has been studied by many authors regarding various effects upon patients' outcomes and surgical conditions. We believe deep neuromuscular blockade can be especially beneficial in laparoscopic surgery, because it can expand surgical space and prevent patients' minute movements that can disturb precise operations. In clinical situations, anesthetists tend to compensate the insufficiency of neuromuscular blockade by increasing the dose of other anesthetic agents, which can prolong patients' recovery time and impair the surgical condition. In this study, we plan to divide the patients into 2 groups according to the depth of neuromuscular blockade, and compare the dose of anesthetic agent used to maintain surgical condition.
Detailed description
Patients undergoing elective laparoscopic colorectal surgery are going to be recruited and divided into 2 groups: Group D will receive deep neuromuscular blockade, and Group M will receive moderate neuromuscular blockade using continuous infusion of rocuronium. Acceleromyography(TOF-watch SX) will be used to monitor the depth of blockade. In both groups, the anesthesia will be maintained with TIVA(total intra-venous anesthesia) including continuous target-controlled infusion of propofol and remifentanil. During the surgery, the number of patient movement and restoration of self respiration will be recorded. At the end of anesthesia, the dose of propofol and remifentanil used will be assessed and compared between the groups. Also, the satisfaction score of surgeons regarding the surgical condition, the anesthesia time, the operation time will be documented. After the patients are discharged, their charts are going to be reviewed and whether any pulmonary or surgical complications occurred will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D | Experimental | Drug: Rocuronium: PTC(Post-tetanic count) 1~2Deep neuromuscular blockade |
| Group M | Active comparator | Drug: Rocuronium: TOF(Train-of-four) 1~2Moderate neuromuscular blockade |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing elective laparoscopic colorectal resection due to benign or malignant neoplasm of colon or rectum
- ASA class I or II
Key exclusion criteria (7 listed)
- Patients receiving medications known to have drug-drug interaction with neuromuscular blocking agents
- Patients who have significantly impaired cardiac, pulmonary, hepatic, renal function
- Patients who are pregnant
- Patients who are known to have hypersensitivity to the anesthetic/analgesic/neuromuscular blocking agents which are going to be used in the study
- BMI < 18.5 or > 35.0 kg/m2
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 |
|---|---|---|
| Rocuronium: PTC(Post-tetanic count) 1~2Also: Deep blockDeep neuromuscular blockade will be maintained using continuous infusion of rocuronium. | Drug | Group D |
| Rocuronium: TOF(Train-of-four) 1~2Also: Moderate blockModerate neuromuscular blockade will be maintained using continuous infusion of rocuronium. | Drug | Group M |
Primary outcome
Dosage of propofol
Time frame: intraoperative (from starting of anesthesia to end of anesthesia)
the amount of propofol used (mg/kg)
4 secondary outcomes
Dosage of remifentanil
Time frame: intraoperative (from starting of anesthesia to end of anesthesia)
Patient movement
Time frame: intraoperative (from tracheal intubation to injection of neuromuscular reversal agent)
Patient self respiration
Time frame: intraoperative (from tracheal intubation to injection of neuromuscular reversal agent)
Surgical condition score
Time frame: assessed at the end of the 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 30 Jun 2020.
- Derived from this study: PubMed 34398011Nam SW, Oh AY, Koo BW, Kim BY, Han J, Chung SH. Effects of depth of neuromuscular blockade on the BIS-guided propofol requirement: A randomized controlled trial. Medicine (Baltimore). 2021 Jul 23;100(29):e26576. doi: 10.1097/MD.0000000000026576.
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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.
Ah Young Oh, MD, PhD study chair
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocuronium: PTC(Post-tetanic count) 1~2 and Rocuronium: TOF(Train-of-four) 1~2 in people with Laparoscopy and General Anesthesia, run by Seoul National University Bundang Hospital 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 2 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 30 Jun 2020. 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?
Dosage of propofol (time frame: intraoperative (from starting of anesthesia to end of anesthesia)). 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 NCT03890406, which also lists 1 linked publication.
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 30 Jun 2020.