Neuromuscular BlockadePhase 4suga-SHNCT02100280
The Effect of Deep Block Versus Moderate Block on the Stress Response After Laparoscopic Gastrectomy
A Phase 4 study testing deep block in people with Neuromuscular Blockade, run by Seoul National University Bundang Hospital.
Trial summary
This study is a multicenter, randomized, controlled, double-blinded, and parallel design study. A total of 96 patients were decided to be recruited considering a 10% dropout rate. Patients are randomized to receive a deep block or a moderate block. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- deep block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 29 Jun 2014to 16 Jun 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists grade 1 or 2
- Scheduled for elective laparoscopic gastrectomy
Who cannot join
- Severe respiratory or cardiac disease
- Severe hepatic or renal function impairment
- On medications affecting neuromuscular function
- Known allergy to the drugs to be used
About this study
Official title: A Double-blinded, Randomized, Parallel Design Study to Compare the Effect of Deep Block Versus Moderate Block on the Stress Response After Laparoscopic Gastrectomy
This study is a multicenter, randomized, controlled, double-blinded, and parallel design study. A total of 96 patients were decided to be recruited considering a 10% dropout rate. Patients are randomized to receive a deep block or a moderate block. The randomization numbers are generated using a computer-generated randomization code (1) and are sealed in the opaque envelope until they are handed over to the anesthesiologist in charge of anesthesia management after the induction of anesthesia. Patients, surgeons reporting the scale of surgical status, and another researcher analysing the cytokines levels are blinded to the patient group. Patients aged 18-65 yr, ASA 1 or 2, and are scheduled for elective laparoscopic gastrectomy are included. Patients with severe respiratory or cardiac disease, hepatic or renal function impairment, on medications affecting neuromuscular function, and with known allergy to the drugs to be used are excluded.
Read the detailed description
Induction and maintenance of anesthesia
Premedication is done with midazolam 0.03 mg/kg IV at reception area. Anesthesia is induced and maintained with intravenous propofol, remifentanil, and rocuronium. The dose of propofol is adjusted to maintain BIS value to 40-60, remifentanil to maintain blood pressure within 20% of preoperative value, and rocuronium to maintain PTC 1-2 (deep block) or TOF1-2 (moderate block). The monitoring consists of ECG, NIBP, pulse oximetry, temperature, ETCO2, BIS, and neuromuscular monitoring with acceleromyography (TOF-Watch SXTM, Organon Ltd., Dublin, Ireland).
Management and monitoring of neuromuscular block
After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of PTC1-2 (deep block) or TOF1-2 (moderate block). At the end of surgery, sugammadex 4 mg/kg for deep block group or neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg for moderate block group are administered IV for reversal of neuromuscular block.
Evaluation of surgical conditions
A 5-point surgical rating scale (1 = excellent, 2 = good, 3 = acceptable, 4 = poor, 5 = extremely poor) is rated by the surgeon who is in charge of the patient's operation and is blind to the patient's group assignment. Intraoperative patient movement reported by surgeon, checked by restoration of spontaneous respiration or sudden increase in PIP, and any other movement are also recorded.
Measurement of cytokines and acute phase reactants
Blood samples are collected from the antecubital vein of the arm not used for IV infusion preoperatively, at the end of peritoneal closure, and 1, 2, \& 48 hr after the end of operation for analysis of TNF-α, IL-1β, 6, 8 and CRP. The blood samples are collected at test tubes and sent to the laboratory on ice. Cytokines are analyzed with enzyme-linked immunosorbent assay and CRP is determined by an institutional chemistry analyzer.
Postoperative pain measurement
Postoperative pain is evaluated by verbal numerical rating scale (VNRS, 0 = no pain, 10 = the severest pain imaginable) at postoperative 1, 2, 6, 24, and 48 hr. Postoperative pain is controlled by IV patient controlled analgesia using fentanyl. If patient complain of severe pain (VNRS score of 7 or more), additional analgesics can be used according to the attending physician. The amount of fentanyl used and additional analgesic drugs used are reported.
- Conditions
- Neuromuscular Blockade
- Being tested
- deep block
- Keywords
- Neuromuscular blockade, Sugammadex, Laparoscopic surgery, IL-6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep blockDrug
Also called bridion
sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
| Study group | Role | What they receive |
|---|---|---|
| deep block | Experimental | After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block. Receives: Drug: deep block |
| moderate block | No intervention | After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6
Blood samples are collected from the antecubital vein of the arm not used for IV infusion 1 hr after the end of operation for analysis of IL- 6.
Measured: 1 hr after the end of operation
Secondary outcomes (4)
TNF-α
Blood samples are collected from the antecubital vein of the arm not used for IV infusion at the end of peritoneal closure for analysis of TNF-α.
Measured: 30min before end of operation
IL-1β
Blood samples are collected from the antecubital vein of the arm not used for IV infusion at the end of peritoneal closure for analysis of IL-1β.
Measured: 30min before end of operation
IL-8
Blood samples are collected from the antecubital vein of the arm not used for IV infusion 1 hr after the end of operation for analysis of IL- 8.
Measured: 1 hr after end of operation
CRP
Blood samples are collected from the antecubital vein of the arm not used for IV infusion 48 hr after the end of operation for analysis of CRP.
Measured: 48 hr after end of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study start29 Jun 2014
- Primary completion14 Jun 2017
- Study completion16 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuromuscular BlockadeStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 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.,Ph.D., Study chair, Seoul national univ. BUNDANG hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100280
- Sponsor's protocol ID
- SNUBH-NMB
- Acronym
- suga-SH
- Status last verified
- Jan 2024
- First submitted
- 23 Mar 2014
- Last updated
- 10 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded, Randomized, Parallel Design Study to Compare the Effect of Deep Block Versus Moderate Block on the Stress Response After Laparoscopic Gastrectomy
- ClinicalTrials.gov ID
- NCT02100280
- Acronym / sponsor ID
- suga-SH / SNUBH-NMB
- Conditions
- Neuromuscular Blockade
- Keywords
- Neuromuscular blockade, Sugammadex, Laparoscopic surgery, IL-6
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 29 Jun 2014 (actual)
- Primary completion
- 14 Jun 2017 (actual)
- Study completion
- 16 Jun 2017 (actual)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Posted 21 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter, randomized, controlled, double-blinded, and parallel design study. A total of 96 patients were decided to be recruited considering a 10% dropout rate. Patients are randomized to receive a deep block or a moderate block. The randomization numbers are generated using a computer-generated randomization code (1) and are sealed in the opaque envelope until they are handed over to the anesthesiologist in charge of anesthesia management after the induction of anesthesia. Patients, surgeons reporting the scale of surgical status, and another researcher analysing the cytokines levels are blinded to the patient group. Patients aged 18-65 yr, ASA 1 or 2, and are scheduled for elective laparoscopic gastrectomy are included. Patients with severe respiratory or cardiac disease, hepatic or renal function impairment, on medications affecting neuromuscular function, and with known allergy to the drugs to be used are excluded.
Detailed description
Induction and maintenance of anesthesia
Premedication is done with midazolam 0.03 mg/kg IV at reception area. Anesthesia is induced and maintained with intravenous propofol, remifentanil, and rocuronium. The dose of propofol is adjusted to maintain BIS value to 40-60, remifentanil to maintain blood pressure within 20% of preoperative value, and rocuronium to maintain PTC 1-2 (deep block) or TOF1-2 (moderate block). The monitoring consists of ECG, NIBP, pulse oximetry, temperature, ETCO2, BIS, and neuromuscular monitoring with acceleromyography (TOF-Watch SXTM, Organon Ltd., Dublin, Ireland).
Management and monitoring of neuromuscular block
After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of PTC1-2 (deep block) or TOF1-2 (moderate block). At the end of surgery, sugammadex 4 mg/kg for deep block group or neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg for moderate block group are administered IV for reversal of neuromuscular block.
Evaluation of surgical conditions
A 5-point surgical rating scale (1 = excellent, 2 = good, 3 = acceptable, 4 = poor, 5 = extremely poor) is rated by the surgeon who is in charge of the patient's operation and is blind to the patient's group assignment. Intraoperative patient movement reported by surgeon, checked by restoration of spontaneous respiration or sudden increase in PIP, and any other movement are also recorded.
Measurement of cytokines and acute phase reactants
Blood samples are collected from the antecubital vein of the arm not used for IV infusion preoperatively, at the end of peritoneal closure, and 1, 2, \& 48 hr after the end of operation for analysis of TNF-α, IL-1β, 6, 8 and CRP. The blood samples are collected at test tubes and sent to the laboratory on ice. Cytokines are analyzed with enzyme-linked immunosorbent assay and CRP is determined by an institutional chemistry analyzer.
Postoperative pain measurement
Postoperative pain is evaluated by verbal numerical rating scale (VNRS, 0 = no pain, 10 = the severest pain imaginable) at postoperative 1, 2, 6, 24, and 48 hr. Postoperative pain is controlled by IV patient controlled analgesia using fentanyl. If patient complain of severe pain (VNRS score of 7 or more), additional analgesics can be used according to the attending physician. The amount of fentanyl used and additional analgesic drugs used are reported.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep block | Experimental | Drug: deep blockAfter induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of post tetanic count 1-2 (deep block). At the end of surgery, sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block. |
| moderate block | No intervention | –After induction of anesthesia, continuous neuromuscular monitoring is started after calibration and stabilization of the signal as recommended by good clinical research practice; 50 Hz tetanic stimulation for 5 s, calibration, stabilization for at least 2 min 2. After stabilization, rocuronium 0.6 mg/kg is administered IV within 5 s for tracheal intubation. Maintenance dose of 0.1-0.2 mg/kg rocuronium is administered as needed for the maintenance of train of four count 1-2 (moderate block). At the end of surgery neostigmine 50 ㎍/kg with glycopyrrolate 10 ㎍/kg are administered IV for reversal of neuromuscular block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists grade 1 or 2
- Scheduled for elective laparoscopic gastrectomy
Key exclusion criteria (4 listed)
- Severe respiratory or cardiac disease
- Severe hepatic or renal function impairment
- On medications affecting neuromuscular function
- Known allergy to the drugs to be used
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 blockAlso: bridionsugammadex 4 mg/kg are administered IV for reversal of neuromuscular block | Drug | deep block |
Primary outcome
IL-6
Time frame: 1 hr after the end of operation
Blood samples are collected from the antecubital vein of the arm not used for IV infusion 1 hr after the end of operation for analysis of IL- 6.
4 secondary outcomes
TNF-α
Time frame: 30min before end of operation
IL-1β
Time frame: 30min before end of operation
IL-8
Time frame: 1 hr after end of operation
CRP
Time frame: 48 hr after end of operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.,Ph.D. study chair
Seoul national univ. BUNDANG hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing deep block in people with Neuromuscular Blockade, run by Seoul National University Bundang 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 2 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 10 Jan 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
IL-6 (time frame: 1 hr after the end of operation). 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 10 Jan 2024.