Drug Interaction PotentiationNCT01736371
Analysis of Cisatracurium Consumption in Balanced Anesthesia With 1% Sevoflurane, and With Only Sevoflurane, Using a Closed-loop Computer Controlled System Infusion.
A study testing 1% Sevoflurane, Propofol and Sevoflurane in people with Drug Interaction Potentiation, run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
The aim in this study was to quantify the difference in cisatracurium and sufentanil consumption, and its recovery period, when patients are under balanced general anesthesia with 1% sevoflurane and patients under only sevoflurane general anesthesia, using a closed loop computer control infusion. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction Potentiation
- What is being tested?
- 1% Sevoflurane, Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Nov 2012
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 20 and 65.
- Patients with ASA 1 and 2.
- Patients for elective abdominal general surgery
Who cannot join
- Patients with the following diseases are excluded, since they are known to cause generalized neuromuscular weakness:
- Neuromuscular junction disorders (e.g.. myasthenia gravis) Myopathies (e.g.. Muscular Dystrophies, Rhabdomyolysis) Peripheral Neuropathies (e.g. Guillain-Barre Syndrome, Polyneuropathies) Encephalopathies (Septic and Toxic-metabolic Encephalopathy) Patients with renal and liver diseases.
- Patients who are sent intubated to ICU after surgery.
- Patients refusal
Trial locations and contacts
1 site in 1 country.
About this study
The aim in this study was to quantify the difference in cisatracurium and sufentanil consumption, and its recovery period, when patients are under balanced general anesthesia with 1% sevoflurane and patients under only sevoflurane general anesthesia, using a closed loop computer control infusion. Investigators further investigated this effect on its recovery period and sufentanyl consumption.
Read the detailed description
156 patients of American Society of Anesthesiologists (ASA) physical status I and II were assigned to three groups. The patients were all on schedule for elective general surgery under general anesthesia with duration of at two to four hours. All patients were induced with Etomidate (0.2mg/kg), Midazolam (0.05-0.1mg/kg), Sufentanil (0.3-0.5µg/kg) and a bolus dose of Cisatracurium (0.15mg/kg). Patients were aged between 20 and 65. The maintenance of anesthesia in each group varies as follows: Patients in Group 1 were all maintained with Total Intravenous Anesthesia, Group 2 with Sevoflurane at 1% and propofol infusion, Group 3 with only sevoflurane. Muscle paralysis is maintained using a closed-loop computer gated infusion of Cisatracurium which kept T1 <1% by giving increasing the infusion rate intra-operatively when required. Analgesia was maintained by intermittent bolus dose of 10-20 µg of Sufentanil.
- Conditions
- Drug Interaction Potentiation
- Being tested
- 1% Sevoflurane, Propofol, Sevoflurane
- Keywords
- Sevoflurane, Cisatracurium infusion consumption, Closed loop computer control system, Recovery Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% SevofluraneDrug
In this group of patients, the maintenance of anesthesia is done by 1% sevoflurane + propofol infusion. Propofol infusion is adjusted according to the Bispectral Index.
PropofolDrug
Also called Total Intravenous Anesthesia
In this group the maintenance of anesthesia is maintained by only propofol infusion.
SevofluraneDrug
In this group only sevoflurane was used for maintenance of anesthesia. the dose of sevoflurane is adjusted to maintain Bispectral Index within 45 and 55.
| Study group | Role | What they receive |
|---|---|---|
| Total Intravenous Anesthesia | Sham comparator | Only propofol infusion is used for maintenance of anesthesia keeping Bispectral Index (BIS) between 45-55. Receives: Drug: Propofol |
| 1% Sevoflurane | Active comparator | 1% Sevoflurane with propofol infusion is used for maintenance. BIS is kept between 45-55 by adjusting propofol infusion. Receives: Drug: 1% Sevoflurane |
| Sevoflurane | Active comparator | Only Sevoflurane is used for maintenance keeping BIS between 45-55 Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cisatracurium consumption rate.
Measurements were done intraoperatively. Investigators obtained data from the closed loop computer system, from which the intra-operative consumption of cisatracurium were obtained from each patient. Data were collected only during surgery. Each patient had different cisatracurium consumption rate, and the mean consumption rate of the patients within the same group were calculated, and compared with the means from the other groups.
Measured: At the time of surgery.
Secondary outcomes (1)
Analysis of Means of Recovery Index.
Recovery Index was the time for the Train-Of-Four ratio (TOF) to increase from 25% to 75%. The TOF ratio was recorded every minute till it reached 90%. Time taken for each patient was from 5 to 25 minutes. Investigators compared the average recovery index of patients from each group.
Measured: 30 minutes post operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Interaction PotentiationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joomye Shehzaad, Tianjin Medical University General Hospital
- Investigators
- Shehzaad Joomye, M.D., Principal investigator, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736371
- Sponsor's protocol ID
- Cis-sevo-123
- Status last verified
- Nov 2012
- First submitted
- 25 Nov 2012
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Cisatracurium Consumption in Balanced Anesthesia With 1% Sevoflurane, and With Only Sevoflurane, Using a Closed-loop Computer Controlled System Infusion.
- ClinicalTrials.gov ID
- NCT01736371
- Acronym / sponsor ID
- Cis-sevo-123
- Conditions
- Drug Interaction Potentiation
- Keywords
- Sevoflurane, Cisatracurium infusion consumption, Closed loop computer control system, Recovery Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 29 Nov 2012 (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.
The aim in this study was to quantify the difference in cisatracurium and sufentanil consumption, and its recovery period, when patients are under balanced general anesthesia with 1% sevoflurane and patients under only sevoflurane general anesthesia, using a closed loop computer control infusion. Investigators further investigated this effect on its recovery period and sufentanyl consumption.
Detailed description
156 patients of American Society of Anesthesiologists (ASA) physical status I and II were assigned to three groups. The patients were all on schedule for elective general surgery under general anesthesia with duration of at two to four hours. All patients were induced with Etomidate (0.2mg/kg), Midazolam (0.05-0.1mg/kg), Sufentanil (0.3-0.5µg/kg) and a bolus dose of Cisatracurium (0.15mg/kg). Patients were aged between 20 and 65. The maintenance of anesthesia in each group varies as follows: Patients in Group 1 were all maintained with Total Intravenous Anesthesia, Group 2 with Sevoflurane at 1% and propofol infusion, Group 3 with only sevoflurane. Muscle paralysis is maintained using a closed-loop computer gated infusion of Cisatracurium which kept T1 <1% by giving increasing the infusion rate intra-operatively when required. Analgesia was maintained by intermittent bolus dose of 10-20 µg of Sufentanil.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Total Intravenous Anesthesia | Sham comparator | Drug: PropofolOnly propofol infusion is used for maintenance of anesthesia keeping Bispectral Index (BIS) between 45-55. |
| 1% Sevoflurane | Active comparator | Drug: 1% Sevoflurane1% Sevoflurane with propofol infusion is used for maintenance. BIS is kept between 45-55 by adjusting propofol infusion. |
| Sevoflurane | Active comparator | Drug: SevofluraneOnly Sevoflurane is used for maintenance keeping BIS between 45-55 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 20 and 65.
- Patients with ASA 1 and 2.
- Patients for elective abdominal general surgery
Key exclusion criteria (4 listed)
- Patients with the following diseases are excluded, since they are known to cause generalized neuromuscular weakness:
- Neuromuscular junction disorders (e.g.. myasthenia gravis) Myopathies (e.g.. Muscular Dystrophies, Rhabdomyolysis) Peripheral Neuropathies (e.g. Guillain-Barre Syndrome, Polyneuropathies) Encephalopathies (Septic and Toxic-metabolic Encephalopathy) Patients with renal and liver diseases.
- Patients who are sent intubated to ICU after surgery.
- Patients refusal
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 |
|---|---|---|
| 1% SevofluraneIn this group of patients, the maintenance of anesthesia is done by 1% sevoflurane + propofol infusion. Propofol infusion is adjusted according to the Bispectral Index. | Drug | 1% Sevoflurane |
| PropofolAlso: Total Intravenous AnesthesiaIn this group the maintenance of anesthesia is maintained by only propofol infusion. | Drug | Total Intravenous Anesthesia |
| SevofluraneIn this group only sevoflurane was used for maintenance of anesthesia. the dose of sevoflurane is adjusted to maintain Bispectral Index within 45 and 55. | Drug | Sevoflurane |
Primary outcome
Cisatracurium consumption rate.
Time frame: At the time of surgery.
Measurements were done intraoperatively. Investigators obtained data from the closed loop computer system, from which the intra-operative consumption of cisatracurium were obtained from each patient. Data were collected only during surgery. Each patient had different cisatracurium consumption rate, and the mean consumption rate of the patients within the same group were calculated, and compared with the means from the other groups.
1 secondary outcome
Analysis of Means of Recovery Index.
Time frame: 30 minutes post operative.
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 29 Nov 2012.
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.
Shehzaad Joomye, M.D. principal investigator
Tianjin Medical University General 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 1% Sevoflurane, Propofol and Sevoflurane in people with Drug Interaction Potentiation, run by Tianjin Medical University General Hospital at 1 site in 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 3 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 29 Nov 2012. 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 China. 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. Some participants in this study may receive a placebo. 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?
Cisatracurium consumption rate. (time frame: At the time 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 29 Nov 2012.