Neuromuscular MonitoringNCT02711917
Rocuronium Consumption in Etomidate-based and Propofol-based General Anesthesia Under Sevoflurane
A study testing MAC 0.5, MAC 0.75 and MAC 1.0 in people with Neuromuscular Monitoring, run by Tianjin Medical University General Hospital.
Trial summary
Different concentration of sevoflurane was given to maintain anesthesia. The dose of propofol to maintain BIS between 40-60 and the consumption of rocuronium was recorded and evaluated. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Monitoring
- What is being tested?
- MAC 0.5, MAC 0.75 and MAC 1.0
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Jan 2016
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI < 30
- elective Gynaecological/abdominal/urological surgery
- Operation time < 3hrs
- ASA I/II
- Intubated patients
Who cannot join
- Coronary artery disease, cardiac, lung, hepatic and renal insufficiency
- Severe uncontrolled HBP
- Obesity (BMI >30)
- Neuromuscular and metabolic diseases
- Receiving medication known to influence neuromuscular transmission
- Pregnancy
- Psychiatric disorders
- Allergy history to any of the drugs that will be used
About this study
Official title: Consumption of Rocuronium Under Etomidate-based Versus Propofol-based Maintenance of General Anesthesia Under Different Concentration of Sevoflurane- BIS Guided Clinical Trial in a Closed Loop Infusion System
Different concentration of sevoflurane was given to maintain anesthesia. The dose of propofol to maintain BIS between 40-60 and the consumption of rocuronium was recorded and evaluated.
Read the detailed description
2 age group of patients was selected, 40-60 years and above 60 years. Maintenance of anesthesia was carried out using different concentration of Sevoflurane, ie MAC 0.5, 0.75 and 1.0. Bis value was kept between 40-60 and the dose of propofol required was recorded. Rocuronium infusion given in a close loop infusion system for different group was tabulated. The results was then analysed.
- Conditions
- Neuromuscular Monitoring
- Being tested
- MAC 0.5, MAC 0.75, MAC 1.0, Propofol, Etomidate
- Keywords
- Propofol, Sevoflurane, Etomidate, Rocuronium, BIS, Closed loop infusion system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAC 0.5Drug
0.5 MAC Sevoflurane
MAC 0.75Drug
0.75 MAC Sevoflurane
MAC 1.0Drug
1.0 MAC Sevoflurane
PropofolDrug
Propofol consumption
EtomidateDrug
Etomidate consumption
RocuroniumDrug
Consumption of Rocuronium
| Study group | Role | What they receive |
|---|---|---|
| SP1- sevoflurane MAC 0.5 | Experimental | In this group, patient of age 40-60 years of age, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, Sevoflurane is started to achieve the desired MAC of 0.5. Propofol infusion is started to keep BIS between 40-60. Receives: Drug: MAC 0.5; Drug: Propofol; Drug: Rocuronium |
| SP2- Sevoflurane MAC 0.75 | Experimental | In this group, patient of age 40-60 years, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen.Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, Sevoflurane is started to achieve the desired MAC of 0.75. Propofol infusion is started to keep BIS between 40-60. Receives: Drug: MAC 0.75; Drug: Propofol; Drug: Rocuronium |
| SP3 -Sevoflurane MAC 1.0 | Experimental | In this group, patient of age 40-60 years, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, Sevoflurane is started to achieve the desired MAC of 1.0. Propofol infusion is started to keep BIS between 40-60. Receives: Drug: MAC 1.0; Drug: Propofol; Drug: Rocuronium |
| SP4- Sevoflurane MAC 0.5 | Experimental | In this group, patient above 60 years of age, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, sevoflurane is started to achieve the desired MAC of 0.5. Propofol infusion is started to keep BIS between 40-60. Receives: Drug: MAC 0.5; Drug: Propofol; Drug: Rocuronium |
| SP5- Sevoflurane MAC 0.75 | Experimental | In this group, patient above 60 years of age, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, Sevoflurane is started to achieve the desired MAC of 0.75. Propofol infusion is started to keep BIS between 40-60. Receives: Drug: MAC 0.75; Drug: Propofol; Drug: Rocuronium |
| SE1- Sevoflurane MAC 0.5 | Experimental | In this group, patient of age 40-60 years of age, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, sevoflurane is started to achieve the desired MAC of 0.5. Etomidate infusion is started to keep BIS between 40-60. Receives: Drug: MAC 0.5; Drug: Etomidate; Drug: Rocuronium |
| SE2- Sevoflurane 0.75 | Experimental | In this group, patient of age 40-60 years of age, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, sevoflurane is started to achieve the desired MAC of 0.5. Etomidate infusion is started to keep BIS between 40-60. Receives: Drug: MAC 0.75; Drug: Etomidate; Drug: Rocuronium |
| SE3- Sevoflurane MAC 1.0 | Experimental | In this group, patient of age 40-60 years of age, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, Sevoflurane is started to achieve the desired MAC of 0.5. Etomidate infusion is started to keep BIS between 40-60. Receives: Drug: MAC 1.0; Drug: Etomidate; Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
consumption of propofol
Propofol, Etomidate, Rocuronium consumption under specific concentration of sevoflurane keeping BIS between 40-60
Measured: Intraoperative
Secondary outcomes (3)
Recovery Index
T25%-T75%
Measured: Intraoperative
Onset time
Time from starting infusion of Rocuronium at induction till T<10%
Measured: Intraoperative
Sevoflurane time
Time from starting sevoflurane till end tidal concentration is reached
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular MonitoringStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guolin Wang, Tianjin Medical University General Hospital
- Investigators
- Guolin Wang, Professor, Principal investigator, Head of department anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711917
- Sponsor's protocol ID
- TianjinMUGH
- Other IDs
- Narina Goulvaden
- Status last verified
- Mar 2016
- First submitted
- 24 Feb 2016
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consumption of Rocuronium Under Etomidate-based Versus Propofol-based Maintenance of General Anesthesia Under Different Concentration of Sevoflurane- BIS Guided Clinical Trial in a Closed Loop Infusion System
- ClinicalTrials.gov ID
- NCT02711917
- Acronym / sponsor ID
- TianjinMUGH
- Conditions
- Neuromuscular Monitoring
- Keywords
- Propofol, Sevoflurane, Etomidate, Rocuronium, BIS, Closed loop infusion system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 17 Mar 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.
Different concentration of sevoflurane was given to maintain anesthesia. The dose of propofol to maintain BIS between 40-60 and the consumption of rocuronium was recorded and evaluated.
Detailed description
2 age group of patients was selected, 40-60 years and above 60 years. Maintenance of anesthesia was carried out using different concentration of Sevoflurane, ie MAC 0.5, 0.75 and 1.0. Bis value was kept between 40-60 and the dose of propofol required was recorded. Rocuronium infusion given in a close loop infusion system for different group was tabulated. The results was then analysed.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| SP1- sevoflurane MAC 0.5 | Experimental | Drug: MAC 0.5, Drug: Propofol, Drug: RocuroniumIn this group, patient of age 40-60 years of age, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, Sevoflurane is started to achieve the desired MAC of 0.5. Propofol infusion is started to keep BIS between 40-60. |
| SP2- Sevoflurane MAC 0.75 | Experimental | Drug: MAC 0.75, Drug: Propofol, Drug: RocuroniumIn this group, patient of age 40-60 years, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen.Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, Sevoflurane is started to achieve the desired MAC of 0.75. Propofol infusion is started to keep BIS between 40-60. |
| SP3 -Sevoflurane MAC 1.0 | Experimental | Drug: MAC 1.0, Drug: Propofol, Drug: RocuroniumIn this group, patient of age 40-60 years, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, Sevoflurane is started to achieve the desired MAC of 1.0. Propofol infusion is started to keep BIS between 40-60. |
| SP4- Sevoflurane MAC 0.5 | Experimental | Drug: MAC 0.5, Drug: Propofol, Drug: RocuroniumIn this group, patient above 60 years of age, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, sevoflurane is started to achieve the desired MAC of 0.5. Propofol infusion is started to keep BIS between 40-60. |
| SP5- Sevoflurane MAC 0.75 | Experimental | Drug: MAC 0.75, Drug: Propofol, Drug: RocuroniumIn this group, patient above 60 years of age, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, Sevoflurane is started to achieve the desired MAC of 0.75. Propofol infusion is started to keep BIS between 40-60. |
| SE1- Sevoflurane MAC 0.5 | Experimental | Drug: MAC 0.5, Drug: Etomidate, Drug: RocuroniumIn this group, patient of age 40-60 years of age, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, sevoflurane is started to achieve the desired MAC of 0.5. Etomidate infusion is started to keep BIS between 40-60. |
| SE2- Sevoflurane 0.75 | Experimental | Drug: MAC 0.75, Drug: Etomidate, Drug: RocuroniumIn this group, patient of age 40-60 years of age, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, sevoflurane is started to achieve the desired MAC of 0.5. Etomidate infusion is started to keep BIS between 40-60. |
| SE3- Sevoflurane MAC 1.0 | Experimental | Drug: MAC 1.0, Drug: Etomidate, Drug: RocuroniumIn this group, patient of age 40-60 years of age, ASA I/II, undergoing elective abdominal or gynecological surgery are chosen. Neuromuscular function prior to induction is assessed by acceleromyography by stimulation of ulnar nerve and noting the response of adductor pollicis. After induction and intubation, Sevoflurane is started to achieve the desired MAC of 0.5. Etomidate infusion is started to keep BIS between 40-60. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI < 30
- elective Gynaecological/abdominal/urological surgery
- Operation time < 3hrs
- ASA I/II
- Intubated patients
Key exclusion criteria (8 listed)
- Coronary artery disease, cardiac, lung, hepatic and renal insufficiency
- Severe uncontrolled HBP
- Obesity (BMI >30)
- Neuromuscular and metabolic diseases
- Receiving medication known to influence neuromuscular transmission
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 |
|---|---|---|
| MAC 0.50.5 MAC Sevoflurane | Drug | SE1- Sevoflurane MAC 0.5, SP1- sevoflurane MAC 0.5, SP4- Sevoflurane MAC 0.5 |
| MAC 0.750.75 MAC Sevoflurane | Drug | SE2- Sevoflurane 0.75, SP2- Sevoflurane MAC 0.75, SP5- Sevoflurane MAC 0.75 |
| MAC 1.01.0 MAC Sevoflurane | Drug | SE3- Sevoflurane MAC 1.0, SP3 -Sevoflurane MAC 1.0 |
| PropofolPropofol consumption | Drug | SP1- sevoflurane MAC 0.5, SP2- Sevoflurane MAC 0.75, SP3 -Sevoflurane MAC 1.0, SP4- Sevoflurane MAC 0.5, SP5- Sevoflurane MAC 0.75 |
| EtomidateEtomidate consumption | Drug | SE1- Sevoflurane MAC 0.5, SE2- Sevoflurane 0.75, SE3- Sevoflurane MAC 1.0 |
| RocuroniumConsumption of Rocuronium | Drug | SE1- Sevoflurane MAC 0.5, SE2- Sevoflurane 0.75, SE3- Sevoflurane MAC 1.0, SP1- sevoflurane MAC 0.5, SP2- Sevoflurane MAC 0.75, SP3 -Sevoflurane MAC 1.0, SP4- Sevoflurane MAC 0.5, SP5- Sevoflurane MAC 0.75 |
Primary outcome
consumption of propofol
Time frame: Intraoperative
Propofol, Etomidate, Rocuronium consumption under specific concentration of sevoflurane keeping BIS between 40-60
3 secondary outcomes
Recovery Index
Time frame: Intraoperative
Onset time
Time frame: Intraoperative
Sevoflurane time
Time frame: Intraoperative
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 17 Mar 2016.
- 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.
Guolin Wang, Professor principal investigator
Head of department anesthesiology
Questions about this trial
What is this clinical trial studying?
A study testing MAC 0.5, MAC 0.75 and MAC 1.0 in people with Neuromuscular Monitoring, run by Tianjin Medical University General 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 5 inclusion and 8 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 17 Mar 2016. 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?
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?
consumption of propofol (time frame: Intraoperative). 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 17 Mar 2016.