General AnesthesiaMORENCT03726372
Muscle Relax Affects Outcomes of Robotic Surgery
A study testing Rocuronium, continuous infusion and intermittent injection in people with General Anesthesia and Postoperative Complications, run by Air Force Military Medical University, China.
Trial summary
During robotic laparoscopic surgery, a high intraperitoneal pressure may result in high airway pressure and inadequate perfusion of the abdominal organs, and as a result the postoperative outcomes. Degree of neuromuscular blockade (NMB) can affect the intraperitoneal pressure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- General Anesthesia, Postoperative Complications
- What is being tested?
- Rocuronium, continuous infusion and intermittent injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2018to 10 Nov 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for elective robotic laparoscopic surgery under general anesthesia
- American Society of Anesthesiologists status 1-2
- Body mass index of 18-30kg/m2
- Patients scheduled to be positioned in trendelenburg position during surgery
Who cannot join
- Patients allergic to rocuronium
- Patients with neuromuscular dysfunction
- Patients with existed pulmonary diseases
- Patients with hepatic or renal dysfunction
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Neuromuscular Blockade Protocol on Perioperative Outcomes of Robotic Laparoscopic Surgery
During robotic laparoscopic surgery, a high intraperitoneal pressure may result in high airway pressure and inadequate perfusion of the abdominal organs, and as a result the postoperative outcomes. Degree of neuromuscular blockade (NMB) can affect the intraperitoneal pressure. In this study, the patients undergoing robotic laparoscopic surgery will be assigned to deep NMB group and moderate NMB group. Perioperative outcomes including maximal intraperitoneal pressure, maximal intraoptic pressure, quality of emergence, postoperative pain, and incidence of postoperative respiratory complication will be compared. The results of this study will provide evidence for optimizing NMB protocol of robotic laparoscopic surgery.
- Conditions
- General Anesthesia, Postoperative Complications
- Being tested
- Rocuronium, continuous infusion, intermittent injection
- Keywords
- robotic surgery, laparoscopic surgery, neuromuscular blockade, postoperative complication
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Also called rocuronium bromide
rocuronium is a neuromuscular blocking agent with a duration of 40 minutes
continuous infusionOther
Also called high dose
rocuronium is continuously infused
intermittent injectionOther
Also called low dose
rocuronium is intermittently given
| Study group | Role | What they receive |
|---|---|---|
| deep neuromuscular blockade | Experimental | Rocuronium, a neuromuscular blocking agent will be given by continuous infusion at a dose that reaction to train of four (TOF) stimulation is depressed to zero Receives: Drug: Rocuronium; Other: continuous infusion |
| moderate neuromuscular blockade | Experimental | Rocuronium, a neuromuscular blocking agent will be given at a dose by intermittent injection that reaction to train of four (TOF) stimulation is kept 1 to 2 Receives: Drug: Rocuronium; Other: intermittent injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative major respiratory complications
incidence of pneumonia and atelectasis
Measured: from end of surgery to discharge, at an average of 4 days
Secondary outcomes (11)
maximal airway pressure
airway pressure is titrated to as low as possible as long as the end tidal carbon dioxide partial pressure is lower than 40 mmHg
Measured: from establishment of pneumoperitoneum to end of pneumoperitoneum, at an average of 3 hours
minimal cerebral oxygen saturation
cerebral oxygen saturation is continuously monitored during surgery
Measured: from start of surgery to end of surgery, at an average of 3.5 hours
maximal intraocular pressure
intraocular pressure is monitored every 10 minutes during surgery
Measured: from start of surgery to end of surgery, at an average of 3.5 hours
number of surgeon asking for improving muscle relax
when the surgeon is unsatisfied with the muscle relax, he can tell the anesthetist
Measured: from start of surgery to end of surgery, at an average of 3.5 hours
time to extubation
criteria of extubation: spontaneous respiratory rate>10 per minute and end tidal carbon dioxide partial pressure<45mmHg
Measured: from end of sevoflurane inhalation to extubation, at an average of 20 minutes
incidence of nausea and vomiting in post-anesthesia care unit
Measured: from admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes
incidence of shoulder pain in 24 hours after surgery
Measured: from end of surgery to 24 hours after surgery
incidence of residual neuromuscular blockade in the post-anesthesia care unit
residual neuromuscular blockade is defined as time of head-lift or limb-lift<10 seconds
Measured: from admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes
visual analogue scale at 24 hours after surgery
the patients are asked to mark the score they feel, 0 is no pain,100 is untolerated pain
Measured: end of surgery to 24 hours after surgery
expense after surgery
the expense from immediately after surgery to discharge
Measured: end of the surgery to discharge,at an average of 4 days
satisfaction score of the patients
the patient is asked to give a score between 0 and 10, 0 means not satisfied,10 means totally satisfied.
Measured: from end of surgery to discharge,at an average of 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start10 Nov 2018 (estimated)
- Primary completion10 Nov 2019 (estimated)
- Study completion10 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong LU, Air Force Military Medical University, China
- Investigators
- Zhihong Lu, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726372
- Sponsor's protocol ID
- XJH-A-20180701
- Acronym
- MORE
- Status last verified
- Oct 2018
- First submitted
- 28 Oct 2018
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publishing, data of the primary endpoint and second endpoints can be shared with other researchers
Publications
Van Wijk RM, Watts RW, Ledowski T, Trochsler M, Moran JL, Arenas GW. Deep neuromuscular block reduces intra-abdominal pressure requirements during laparoscopic cholecystectomy: a prospective observational study. Acta Anaesthesiol Scand. 2015 Apr;59(4):434-40. doi: 10.1111/aas.12491. Epub 2015 Feb 13.
PubMed 25684372Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.
PubMed 24240315Barrio J, Errando CL, Garcia-Ramon J, Selles R, San Miguel G, Gallego J. Influence of depth of neuromuscular blockade on surgical conditions during low-pressure pneumoperitoneum laparoscopic cholecystectomy: A randomized blinded study. J Clin Anesth. 2017 Nov;42:26-30. doi: 10.1016/j.jclinane.2017.08.005. Epub 2017 Aug 30.
PubMed 28803124Torensma B, Martini CH, Boon M, Olofsen E, In 't Veld B, Liem RS, Knook MT, Swank DJ, Dahan A. Deep Neuromuscular Block Improves Surgical Conditions during Bariatric Surgery and Reduces Postoperative Pain: A Randomized Double Blind Controlled Trial. PLoS One. 2016 Dec 9;11(12):e0167907. doi: 10.1371/journal.pone.0167907. eCollection 2016.
PubMed 27936214
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromuscular Blockade Protocol on Perioperative Outcomes of Robotic Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT03726372
- Acronym / sponsor ID
- MORE / XJH-A-20180701
- Conditions
- General Anesthesia, Postoperative Complications
- Keywords
- robotic surgery, laparoscopic surgery, neuromuscular blockade, postoperative complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 10 Nov 2018 (estimated)
- Primary completion
- 10 Nov 2019 (estimated)
- Study completion
- 10 Nov 2019 (estimated)
- First posted
- 31 Oct 2018 (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.
During robotic laparoscopic surgery, a high intraperitoneal pressure may result in high airway pressure and inadequate perfusion of the abdominal organs, and as a result the postoperative outcomes. Degree of neuromuscular blockade (NMB) can affect the intraperitoneal pressure. In this study, the patients undergoing robotic laparoscopic surgery will be assigned to deep NMB group and moderate NMB group. Perioperative outcomes including maximal intraperitoneal pressure, maximal intraoptic pressure, quality of emergence, postoperative pain, and incidence of postoperative respiratory complication will be compared. The results of this study will provide evidence for optimizing NMB protocol of robotic laparoscopic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep neuromuscular blockade | Experimental | Drug: Rocuronium, Other: continuous infusionRocuronium, a neuromuscular blocking agent will be given by continuous infusion at a dose that reaction to train of four (TOF) stimulation is depressed to zero |
| moderate neuromuscular blockade | Experimental | Drug: Rocuronium, Other: intermittent injectionRocuronium, a neuromuscular blocking agent will be given at a dose by intermittent injection that reaction to train of four (TOF) stimulation is kept 1 to 2 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients scheduled for elective robotic laparoscopic surgery under general anesthesia
- American Society of Anesthesiologists status 1-2
- Body mass index of 18-30kg/m2
- Patients scheduled to be positioned in trendelenburg position during surgery
Key exclusion criteria (4 listed)
- Patients allergic to rocuronium
- Patients with neuromuscular dysfunction
- Patients with existed pulmonary diseases
- Patients with hepatic or renal 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 |
|---|---|---|
| RocuroniumAlso: rocuronium bromiderocuronium is a neuromuscular blocking agent with a duration of 40 minutes | Drug | deep neuromuscular blockade, moderate neuromuscular blockade |
| continuous infusionAlso: high doserocuronium is continuously infused | Other | deep neuromuscular blockade |
| intermittent injectionAlso: low doserocuronium is intermittently given | Other | moderate neuromuscular blockade |
Primary outcome
incidence of postoperative major respiratory complications
Time frame: from end of surgery to discharge, at an average of 4 days
incidence of pneumonia and atelectasis
11 secondary outcomes
maximal airway pressure
Time frame: from establishment of pneumoperitoneum to end of pneumoperitoneum, at an average of 3 hours
minimal cerebral oxygen saturation
Time frame: from start of surgery to end of surgery, at an average of 3.5 hours
maximal intraocular pressure
Time frame: from start of surgery to end of surgery, at an average of 3.5 hours
number of surgeon asking for improving muscle relax
Time frame: from start of surgery to end of surgery, at an average of 3.5 hours
time to extubation
Time frame: from end of sevoflurane inhalation to extubation, at an average of 20 minutes
incidence of nausea and vomiting in post-anesthesia care unit
Time frame: from admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes
incidence of shoulder pain in 24 hours after surgery
Time frame: from end of surgery to 24 hours after surgery
incidence of residual neuromuscular blockade in the post-anesthesia care unit
Time frame: from admittance to post-anesthesia care unit(PACU) to discharge from PACU, at an average of 30 minutes
visual analogue scale at 24 hours after surgery
Time frame: end of surgery to 24 hours after surgery
expense after surgery
Time frame: end of the surgery to discharge,at an average of 4 days
satisfaction score of the patients
Time frame: from end of surgery to discharge,at an average of 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Background: PubMed 25684372Van Wijk RM, Watts RW, Ledowski T, Trochsler M, Moran JL, Arenas GW. Deep neuromuscular block reduces intra-abdominal pressure requirements during laparoscopic cholecystectomy: a prospective observational study. Acta Anaesthesiol Scand. 2015 Apr;59(4):434-40. doi: 10.1111/aas.12491. Epub 2015 Feb 13.
- Background: PubMed 24240315Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.
- Background: PubMed 28803124Barrio J, Errando CL, Garcia-Ramon J, Selles R, San Miguel G, Gallego J. Influence of depth of neuromuscular blockade on surgical conditions during low-pressure pneumoperitoneum laparoscopic cholecystectomy: A randomized blinded study. J Clin Anesth. 2017 Nov;42:26-30. doi: 10.1016/j.jclinane.2017.08.005. Epub 2017 Aug 30.
- Background: PubMed 27936214Torensma B, Martini CH, Boon M, Olofsen E, In 't Veld B, Liem RS, Knook MT, Swank DJ, Dahan A. Deep Neuromuscular Block Improves Surgical Conditions during Bariatric Surgery and Reduces Postoperative Pain: A Randomized Double Blind Controlled Trial. PLoS One. 2016 Dec 9;11(12):e0167907. doi: 10.1371/journal.pone.0167907. eCollection 2016.
- Individual participant dataSharing planned: Yes. After publishing, data of the primary endpoint and second endpoints can be shared with other researchers
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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.
Zhihong Lu principal investigator
Xijing Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Rocuronium, continuous infusion and intermittent injection in people with General Anesthesia and Postoperative Complications, run by Air Force Military Medical University, 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 4 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: status not confirmed, as of the sponsor's last update on 31 Oct 2018. 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.
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 Zhihong Lu (86-13891975018 ext. 13891975018, deerlu23@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative major respiratory complications (time frame: from end of surgery to discharge, at an average of 4 days). 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 NCT03726372, which also lists 4 linked publications.
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 31 Oct 2018.