Neuromuscular BlockPhase 4NCT02648503
Deep Neuromuscular Block and Sugammadex Versus Standard of Care on Quality of Recovery in Patient Undergo Elective Laparoscopic Cholecystectomy
A Phase 4 study testing Deep neuromuscular block and Moderate neuromuscular block in people with Neuromuscular Block, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
Single center, prospective, randomized, single blinded, parallel group and controlled, assessor-blinded trial to compare the impact of Deep neuromuscular block and Sugammadex versus Standard of care on Quality of recovery in patient undergo elective laparoscopic cholecystectomy using PQRS at different time-point: 15… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Block
- What is being tested?
- Deep neuromuscular block and Moderate neuromuscular block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteVietnam
- Study dates
- Mar 2016to Dec 2016
- Phase
- Phase 4
- 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
- All adult patients (> 18 years) scheduled for elective Laparoscopic Cholecystectomy with American Society of Anesthesiologist (ASA) class I-III in Hospital of University of Medicine and Pharmacy-Ho Chi Minh City
Who cannot join
- Patients with ASA class IV
- Age <18 years
- Inability to inform consent
- History or suspected with neuromuscular disorders
- Allergies to rocuronium or sugammadex, anesthetics or narcotics drugs
- A history of malignant hyperthermia
Show all 9Show fewer
- A contraindication with neostigmine administration
- Pregnancy or breastfeeding
- Renal and liver insufficiency are excluded from this study
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Operation theathre
Ho Chi Minh City, 700000
Vu TN Phan, PhD. MD, +84-90883458, vuphan682003@yahoo.com
About this study
Single center, prospective, randomized, single blinded, parallel group and controlled, assessor-blinded trial to compare the impact of Deep neuromuscular block and Sugammadex versus Standard of care on Quality of recovery in patient undergo elective laparoscopic cholecystectomy using PQRS at different time-point: 15 minutes (T15), 40 minutes (T40), one(D1) and three(D3) days after surgery
Read the detailed description
- In the current study, the investigators investigate the effect of a deep NMB (TOF 0, PTC 1-2) with sugammadex against a moderate block (TOF 1-2) on quality of recovery in patient undergo elective laparoscopic cholecystectomy using PQRS at different time-point: 15 minutes (T15), 40 minutes (T40), one(D1) and three(D3) days after surgery.
- Based on a previous study comparing the Quality of recovery using PQRS between Neostigmine and Sugammadex, P. Amorim at al. showed that the percentage of patients fully awake at 40 min was 96.2% in the sugammadex group and 72.9% in the neostigmine group; the investigators expected the percentage of patient recovery at T40 will be 90% in group D (sugammadex) and 70% in group M (neostigmine)12. Recovery defined as return to the value of PQRS measured prior to surgery or higher. Using the formula for the sample size with α=0.05, Power: 80%, the sample size required per group is 60.
- Eligible patients will be randomly allocated into two groups using a computer-generated randomization before patients arrive to the operating room: Group D with deep, continuous neuromuscular blockade and Group M with moderate neuromuscular blockade.
- All information about group allocation, doses of rocuronium and sugammadex and neuromuscular data are recorded on a separate form and placed in a sealed opaque envelope when the patient is leaving the operating room. This will keep the personnel in the post-anesthesia care unit and the investigator collecting post-operative data blinded to group allocation.
- The investigators use acceleromyography (TOF-Watch SX) to monitor the level of neuromuscular blockage at the adductor pollicis muscle
- Involuntary movement will be recorded by anesthesia during surgery.
- Surgical condition will be rated by surgeons after surgery using five-point surgical condition scale (SRS)
- Hemodynamic changes using the noninvasive Nihon Konden (Nihon Konden, Japan), duration of surgery, drug dosages used during anesthesia, and duration from reversal to extubation, BIS, and ventilatory variables (tidal volume, respiratory rate, breathing pressure).
- Intra-abdominal pressure will be measured every 15 minutes from the peritoneal CO2 insufflation device. Pneumoperitoneum is obtained with insufflation of CO2 at 8 mmHg after the introduction of the trocars. In case of inadequate surgical conditions:
- Increase of pre-set intra-abdominal pressure to 12-14 mmHg.
- If still not adequate, patients will be given a bolus of rocuronium 0.075-0.15 mg/kg
- If still not adequate, the surgeon will decide according to usual clinical practice.
- The intervention will be recorded by anesthesiologist and surgical condition rate will be measured at the time of surgery when they get worse.
- PQRS includes six domains of recovery: physiologic, nociceptive, emotive, activities of daily living, cognitive, and overall patient perspective. There is a series of questions in each domain2. PQRS data will be presented as percentage of patients that recovered for measurements taken at T15, T40, D1, and D3.
- Data of all patients that completed the baseline evaluation and T15 and T40 of the follow-up evaluations will be included in primary efficacy analysis.
- Continuous data will be presented as mean and standard deviation (SD) or median and range (minimum, maximum) and interquartile range (IQR, 25th 75th percentile). Categorical data will be presented as frequencies and percentages.
- The physiological domain data will be presented as mean and SD. The nociceptive domain data will be presented as mean with the 95% confidence intervals (CI).
- Categorical variables will be compared with the the Fisher exact test.
- For the comparison of continuous data, the Student's t test will be used. If there is substantial evidence of departures from normality, then the Mann-Whitney U-test will be performed as a sensitivity analysis.
- Data will be analyzed with the Statistical Package for the Social Sciences statistical software program. Statistical significance was set at P less than 0.05.
- Conditions
- Neuromuscular Block
- Being tested
- Deep neuromuscular block, Moderate neuromuscular block
- Keywords
- Sugammadex, Post-operative Quality Recovery Scale (PQRS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep neuromuscular blockDrug
Also called Esmeron and Bridion
Using rocuronium and reversal with sugammadex
Moderate neuromuscular blockDrug
Also called Esmeron and Neostigmin/Atropine
Using rocuronium and reversal with neostigmine (1 to 2 mg) and atropine (0.5 to 1 mg)
| Study group | Role | What they receive |
|---|---|---|
| Deep neuromuscular block | Experimental | PTC=1-2 Receives: Drug: Deep neuromuscular block |
| Moderate neuromuscular block | Active comparator | TOF=1-2 Receives: Drug: Moderate neuromuscular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery
The primary outcome is to access the differences of Quality of recovery in the overall recovery of the Post-operative Quality Recovery Scale (PQRS) instrument at 40 minutes (T40) after the end of surgery between Deep NMB (reversed with Sugammadex) and Standard of care in patients who undergo Laparoscopic Cholecystectomy.
PQRS includes six domains of recovery: physiologic, nociceptive, emotive, activities of daily living, cognitive, and overall patient perspective. There is a series of questions in each domain. The Postoperative Quality Recovery Scale (PQRS) will be performed and recorded face-to-face by anesthesiologists in hospital and by telephone after discharge. The PQRS is completed prior to surgery to provide baseline values. Recovery is defined as returning to baseline values or better in each of the questions or assessments.
Measured: 40 minutes (T40) after the end of surgery
Secondary outcomes (2)
Quality of recovery
- The differences of Quality of recovery in the overall recovery of the PQRS instrument at 15 minutes (T15), and first day, 3 days after the end of surgery
- The differences between each domain of PQRS instrument from 2 groups.
Measured: 15 minutes (T15), and first day, 3 days after the end of surgery
Shoulder tip pain
using a 100 mm visual analogue scale (VAS) (0 indicating no pain and 100 worst imaginable pain)
Measured: first hour, 6 hours and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Phan Ton Ngoc Vu, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Vu TN Phan, PhD. MD, Principal investigator, University medical center HCMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648503
- Sponsor's protocol ID
- 8616-138
- Status last verified
- Jan 2016
- First submitted
- 7 Dec 2015
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Neuromuscular Block and Sugammadex Versus Standard of Care on Quality of Recovery in Patient Undergo Elective Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT02648503
- Acronym / sponsor ID
- 8616-138
- Conditions
- Neuromuscular Block
- Keywords
- Sugammadex, Post-operative Quality Recovery Scale (PQRS)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 7 Jan 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.
Single center, prospective, randomized, single blinded, parallel group and controlled, assessor-blinded trial to compare the impact of Deep neuromuscular block and Sugammadex versus Standard of care on Quality of recovery in patient undergo elective laparoscopic cholecystectomy using PQRS at different time-point: 15 minutes (T15), 40 minutes (T40), one(D1) and three(D3) days after surgery
Detailed description
- In the current study, the investigators investigate the effect of a deep NMB (TOF 0, PTC 1-2) with sugammadex against a moderate block (TOF 1-2) on quality of recovery in patient undergo elective laparoscopic cholecystectomy using PQRS at different time-point: 15 minutes (T15), 40 minutes (T40), one(D1) and three(D3) days after surgery.
- Based on a previous study comparing the Quality of recovery using PQRS between Neostigmine and Sugammadex, P. Amorim at al. showed that the percentage of patients fully awake at 40 min was 96.2% in the sugammadex group and 72.9% in the neostigmine group; the investigators expected the percentage of patient recovery at T40 will be 90% in group D (sugammadex) and 70% in group M (neostigmine)12. Recovery defined as return to the value of PQRS measured prior to surgery or higher. Using the formula for the sample size with α=0.05, Power: 80%, the sample size required per group is 60.
- Eligible patients will be randomly allocated into two groups using a computer-generated randomization before patients arrive to the operating room: Group D with deep, continuous neuromuscular blockade and Group M with moderate neuromuscular blockade.
- All information about group allocation, doses of rocuronium and sugammadex and neuromuscular data are recorded on a separate form and placed in a sealed opaque envelope when the patient is leaving the operating room. This will keep the personnel in the post-anesthesia care unit and the investigator collecting post-operative data blinded to group allocation.
- The investigators use acceleromyography (TOF-Watch SX) to monitor the level of neuromuscular blockage at the adductor pollicis muscle
- Involuntary movement will be recorded by anesthesia during surgery.
- Surgical condition will be rated by surgeons after surgery using five-point surgical condition scale (SRS)
- Hemodynamic changes using the noninvasive Nihon Konden (Nihon Konden, Japan), duration of surgery, drug dosages used during anesthesia, and duration from reversal to extubation, BIS, and ventilatory variables (tidal volume, respiratory rate, breathing pressure).
- Intra-abdominal pressure will be measured every 15 minutes from the peritoneal CO2 insufflation device. Pneumoperitoneum is obtained with insufflation of CO2 at 8 mmHg after the introduction of the trocars. In case of inadequate surgical conditions:
- Increase of pre-set intra-abdominal pressure to 12-14 mmHg.
- If still not adequate, patients will be given a bolus of rocuronium 0.075-0.15 mg/kg
- If still not adequate, the surgeon will decide according to usual clinical practice.
- The intervention will be recorded by anesthesiologist and surgical condition rate will be measured at the time of surgery when they get worse.
- PQRS includes six domains of recovery: physiologic, nociceptive, emotive, activities of daily living, cognitive, and overall patient perspective. There is a series of questions in each domain2. PQRS data will be presented as percentage of patients that recovered for measurements taken at T15, T40, D1, and D3.
- Data of all patients that completed the baseline evaluation and T15 and T40 of the follow-up evaluations will be included in primary efficacy analysis.
- Continuous data will be presented as mean and standard deviation (SD) or median and range (minimum, maximum) and interquartile range (IQR, 25th 75th percentile). Categorical data will be presented as frequencies and percentages.
- The physiological domain data will be presented as mean and SD. The nociceptive domain data will be presented as mean with the 95% confidence intervals (CI).
- Categorical variables will be compared with the the Fisher exact test.
- For the comparison of continuous data, the Student's t test will be used. If there is substantial evidence of departures from normality, then the Mann-Whitney U-test will be performed as a sensitivity analysis.
- Data will be analyzed with the Statistical Package for the Social Sciences statistical software program. Statistical significance was set at P less than 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep neuromuscular block | Experimental | Drug: Deep neuromuscular blockPTC=1-2 |
| Moderate neuromuscular block | Active comparator | Drug: Moderate neuromuscular blockTOF=1-2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients (> 18 years) scheduled for elective Laparoscopic Cholecystectomy with American Society of Anesthesiologist (ASA) class I-III in Hospital of University of Medicine and Pharmacy-Ho Chi Minh City
Key exclusion criteria (9 listed)
- Patients with ASA class IV
- Age <18 years
- Inability to inform consent
- History or suspected with neuromuscular disorders
- Allergies to rocuronium or sugammadex, anesthetics or narcotics drugs
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 blockAlso: Esmeron and BridionUsing rocuronium and reversal with sugammadex | Drug | Deep neuromuscular block |
| Moderate neuromuscular blockAlso: Esmeron and Neostigmin/AtropineUsing rocuronium and reversal with neostigmine (1 to 2 mg) and atropine (0.5 to 1 mg) | Drug | Moderate neuromuscular block |
Primary outcome
Quality of recovery
Time frame: 40 minutes (T40) after the end of surgery
The primary outcome is to access the differences of Quality of recovery in the overall recovery of the Post-operative Quality Recovery Scale (PQRS) instrument at 40 minutes (T40) after the end of surgery between Deep NMB (reversed with Sugammadex) and Standard of care in patients who undergo Laparoscopic Cholecystectomy. PQRS includes six domains of recovery: physiologic, nociceptive, emotive, activities of daily living, cognitive, and overall patient perspective. There is a series of questions in each domain. The Postoperative Quality Recovery Scale (PQRS) will be performed and recorded face-to-face by anesthesiologists in hospital and by telephone after discharge. The PQRS is completed prior to surgery to provide baseline values. Recovery is defined as returning to baseline values or better in each of the questions or assessments.
2 secondary outcomes
Quality of recovery
Time frame: 15 minutes (T15), and first day, 3 days after the end of surgery
Shoulder tip pain
Time frame: first hour, 6 hours and 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
- Individual participant dataSharing planned: Yes
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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.
Vu TN Phan, PhD. MD principal investigator
University medical center HCMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Deep neuromuscular block and Moderate neuromuscular block in people with Neuromuscular Block, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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 9 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: status not confirmed, as of the sponsor's last update on 7 Jan 2016. 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 Vietnam. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vu TN Phan, PhD. MD (+84-908883458, vuphan682003@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery (time frame: 40 minutes (T40) 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 7 Jan 2016.