The Intraoperative Effect of Dexmedetomidine on Cisatracurium Infusion Consumption and Its Recovery Index.NCT01785446
Study of Cisatracurium and Sufentanil Consumption Using a Closed Loop Computer Control Infusion System
A study testing Effect of dexmedetomidine on cisatracurium and sufentanil consumption and Consumption of cisatracurium and sufentanil in different age groups. in people with The Intraoperative Effect of Dexmedetomidine on Cisatracurium Infusion Consumption and Its Recovery Index. and Effect of Dexmedetomidine on Sufentanil Consumption., run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
The purpose of this study is to: determine the effect of dexmedetomidine on cisatracurium infusion requirements and sufentanil consumption. analyze the cisatracurium infusion requirements and sufentanil consumption in different age groups. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- The Intraoperative Effect of Dexmedetomidine on Cisatracurium Infusion Consumption and Its Recovery Index., Effect of Dexmedetomidine on Sufentanil Consumption., Quantitative Analysis of Cisatracurium Infusion Requirements, Sufentanil Consumption and Recovery Index in Different Age Groups.
- What is being tested?
- Effect of dexmedetomidine on cisatracurium and sufentanil consumption and Consumption of cisatracurium and sufentanil in different age groups.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Feb 2013
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA status 1 and 2.
- Consent approval written and oral.
- Patients scheduled for elective abdominal surgery under general anesthesia.
Who cannot join
- Patients with neuromuscular disorders.
- Patients with history of stroke, flaccid paralysis or other neurological disorders.
- Significant renal, hepatic or cardiac dysfunction.
- Consent refusal.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Guolin Wang, MD, PhD, Professor
Shehzaad Joomye, MD
About this study
Official title: Effect of Dexmedetomidine on Cisatracurium Infusion and Sufentanil Consumption and Its Variations in Different Age Groups, Using a Closed Loop Computer Controlled System.
The purpose of this study is to:
- determine the effect of dexmedetomidine on cisatracurium infusion requirements and sufentanil consumption.
- analyze the cisatracurium infusion requirements and sufentanil consumption in different age groups.
- Conditions
- The Intraoperative Effect of Dexmedetomidine on Cisatracurium Infusion Consumption and Its Recovery Index., Effect of Dexmedetomidine on Sufentanil Consumption., Quantitative Analysis of Cisatracurium Infusion Requirements, Sufentanil Consumption and Recovery Index in Different Age Groups.
- Being tested
- Effect of dexmedetomidine on cisatracurium and sufentanil consumption, Consumption of cisatracurium and sufentanil in different age groups.
- Keywords
- Dexmedetomidine, Cisatracurion infusion, Sufentanil, Recovery Index, Closed loop computer control system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of dexmedetomidine on cisatracurium and sufentanil consumptionDrug
Also called Dexmedetomidine
In this intervention we compared the cisatracurium consumption, recovery index and sufentanil consumption between P2 and D. The reason we are comparing patients in group D with P2 is that because they belong to the same age group.
Consumption of cisatracurium and sufentanil in different age groups.Drug
For this intervention, we compared the cisatracurium consumption, refractory index and sufentanil consumption between group P1, P2 and P3.
| Study group | Role | What they receive |
|---|---|---|
| P 1 | Active comparator | In this group patients were aged from 20 to 45. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55.
Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis. Receives: Drug: Consumption of cisatracurium and sufentanil in different age groups. |
| P 2 | Active comparator | In this group patients were aged from 46 to 65. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55.
Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis. Receives: Drug: Effect of dexmedetomidine on cisatracurium and sufentanil consumption; Drug: Consumption of cisatracurium and sufentanil in different age groups. |
| P 3 | Active comparator | In this group patients were aged from 66 to 85. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55.
Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis. Receives: Drug: Consumption of cisatracurium and sufentanil in different age groups. |
| D | Active comparator | In this group patients were aged from 46to 65. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55.
Dexmedetomidine infusion is started at induction,a bolus dose of 0.5 µg/kg is given over the first hour which is followed by infusion of 0.4 µg/kg/hr.
Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis. Receives: Drug: Effect of dexmedetomidine on cisatracurium and sufentanil consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cisatracurium infusion consumption.
Measurements were done during the operation. Cisatracurium infusion was controlled a closed loop computer system. The degree of neuromuscular blockage was assessed every 20 seconds throughout the procedure using the train of four testing. It was done by counting the number and amplitude of twitches evoked after electrical stimulus and the rate of infusion maintained itself at the low rate of 0.20µg/kg/min as long as the T1 response is less than 1%. When the T1 > 1%, the rate of infusion would automatically increase to 5.0 µg/kg/min until T1 < 1%, after which the infusion rate would fall back to 0.20µg/kg/min. The controlled infusion described above administered small doses of cisatracurium intra-operatively to maintain a muscle relaxation of more than 99%. The system saved the time and amount of drug given throughout the operation, from which the consumption was calculated in µg/kg/min.
Measured: At the time of surgery
Secondary outcomes (1)
Sufentanil consumption.
Analgesia was maintained by intermittent bolus dose of 10-20 µg of Sufentanil when the pulse and blood pressure would increase by more than 20% of the baseline, and BIS in the required range, as this would indicate an increase perception of pain but adequate anaesthesia. Sufentanil consumption was calculated for each patient in µg/kg/hr and the length of the operation was determined as from induction to the time of skin closure.
Measured: At the time of operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Intraoperative Effect of Dexmedetomidine on Cisatracurium Infusion Consumption and Its Recovery Index.Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shehzaad Joomye, Haiyun Wang, Donglai Yan
- Responsible party
- Principal investigator, Guolin Wang, MD, PhD, Professor, Tianjin Medical University General Hospital
- Investigators
- Guolin Wang, MD, PhD, Professor, Principal investigator, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785446
- Sponsor's protocol ID
- Cis-123
- Status last verified
- Feb 2013
- First submitted
- 4 Feb 2013
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Joomye S, Yan D, Wang H, Zhou G, Wang G. Consumption of Cisatracurium in different age groups, using a closed loop computer controlled system. BMC Anesthesiol. 2014 Apr 21;14:29. doi: 10.1186/1471-2253-14-29. eCollection 2014.
PubMed 24745306
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on Cisatracurium Infusion and Sufentanil Consumption and Its Variations in Different Age Groups, Using a Closed Loop Computer Controlled System.
- ClinicalTrials.gov ID
- NCT01785446
- Acronym / sponsor ID
- Cis-123
- Conditions
- The Intraoperative Effect of Dexmedetomidine on Cisatracurium Infusion Consumption and Its Recovery Index., Effect of Dexmedetomidine on Sufentanil Consumption., Quantitative Analysis of Cisatracurium Infusion Requirements, Sufentanil Consumption and Recovery Index in Different Age Groups.
- Keywords
- Dexmedetomidine, Cisatracurion infusion, Sufentanil, Recovery Index, Closed loop computer control system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Collaborators
- Shehzaad Joomye, Haiyun Wang, Donglai Yan
- Study start
- Nov 2012
- Primary completion
- Feb 2013 (estimated)
- First posted
- 7 Feb 2013 (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 purpose of this study is to:
- determine the effect of dexmedetomidine on cisatracurium infusion requirements and sufentanil consumption.
- analyze the cisatracurium infusion requirements and sufentanil consumption in different age groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| P 1 | Active comparator | Drug: Consumption of cisatracurium and sufentanil in different age groups.In this group patients were aged from 20 to 45. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55. Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis. |
| P 2 | Active comparator | Drug: Effect of dexmedetomidine on cisatracurium and sufentanil consumption, Drug: Consumption of cisatracurium and sufentanil in different age groups.In this group patients were aged from 46 to 65. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55. Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis. |
| P 3 | Active comparator | Drug: Consumption of cisatracurium and sufentanil in different age groups.In this group patients were aged from 66 to 85. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55. Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis. |
| D | Active comparator | Drug: Effect of dexmedetomidine on cisatracurium and sufentanil consumptionIn this group patients were aged from 46to 65. Propofol infusion was used to maintain Bispectral Index (BIS) between 45 and 55. Dexmedetomidine infusion is started at induction,a bolus dose of 0.5 µg/kg is given over the first hour which is followed by infusion of 0.4 µg/kg/hr. Intermittent doses of sufentanil 10-20 microgram were given intra-operatively on a required basis. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA status 1 and 2.
- Consent approval written and oral.
- Patients scheduled for elective abdominal surgery under general anesthesia.
Key exclusion criteria (4 listed)
- Patients with neuromuscular disorders.
- Patients with history of stroke, flaccid paralysis or other neurological disorders.
- Significant renal, hepatic or cardiac dysfunction.
- Consent 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 |
|---|---|---|
| Effect of dexmedetomidine on cisatracurium and sufentanil consumptionAlso: DexmedetomidineIn this intervention we compared the cisatracurium consumption, recovery index and sufentanil consumption between P2 and D. The reason we are comparing patients in group D with P2 is that because they belong to the same age group. | Drug | D, P 2 |
| Consumption of cisatracurium and sufentanil in different age groups.For this intervention, we compared the cisatracurium consumption, refractory index and sufentanil consumption between group P1, P2 and P3. | Drug | P 1, P 2, P 3 |
Primary outcome
Cisatracurium infusion consumption.
Time frame: At the time of surgery
Measurements were done during the operation. Cisatracurium infusion was controlled a closed loop computer system. The degree of neuromuscular blockage was assessed every 20 seconds throughout the procedure using the train of four testing. It was done by counting the number and amplitude of twitches evoked after electrical stimulus and the rate of infusion maintained itself at the low rate of 0.20µg/kg/min as long as the T1 response is less than 1%. When the T1 > 1%, the rate of infusion would automatically increase to 5.0 µg/kg/min until T1 < 1%, after which the infusion rate would fall back to 0.20µg/kg/min. The controlled infusion described above administered small doses of cisatracurium intra-operatively to maintain a muscle relaxation of more than 99%. The system saved the time and amount of drug given throughout the operation, from which the consumption was calculated in µg/kg/min.
1 secondary outcome
Sufentanil consumption.
Time frame: At the time of operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
- Derived from this study: PubMed 24745306Joomye S, Yan D, Wang H, Zhou G, Wang G. Consumption of Cisatracurium in different age groups, using a closed loop computer controlled system. BMC Anesthesiol. 2014 Apr 21;14:29. doi: 10.1186/1471-2253-14-29. eCollection 2014.
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, MD, PhD, Professor 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 Effect of dexmedetomidine on cisatracurium and sufentanil consumption and Consumption of cisatracurium and sufentanil in different age groups. in people with The Intraoperative Effect of Dexmedetomidine on Cisatracurium Infusion Consumption and Its Recovery Index. and Effect of Dexmedetomidine on Sufentanil Consumption., 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: status not confirmed, as of the sponsor's last update on 7 Feb 2013. 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. 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 Shehzaad Joomye, M.D. (8613072283346, s_joomye@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cisatracurium infusion consumption. (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?
On the ClinicalTrials.gov record for NCT01785446, which also lists 1 linked publication.
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 Feb 2013.