Adrenal SuppressionPhase 4NCT02111265
THe Comparison of Target Controlled Infusion of Propofol or Etomidate at General Anesthesia in Geriatric Patients
A Phase 4 study testing Remifentanil, Cisatracurium and Sufentanil in people with Adrenal Suppression and Hemodynamic Instability, run by Second Affiliated Hospital of Xi'an Jiaotong University.
Trial summary
Compare the efficacy and safety of closed-loop target controlled infusion of propofol or etomidate at general anesthesia in geriatric patients Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Adrenal Suppression, Hemodynamic Instability
- What is being tested?
- Remifentanil, Cisatracurium and Sufentanil
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Jul 2014
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Scheduled for Endotracheal intubated and general anesthesia for general surgery patients.
- Age 60-75 yrs.
- American Society of Anesthesia (ASA) classification I-II.
- Expected time of surgery is less than 3 hours. -
Who cannot join
- Body mass index is more than 36kg/m2.
- Systolic blood pressure≥180 mm Hg or <90 mm Hg，diastolic blood pressure≥110 mm Hg or < 60 mm Hg.
- Serious cardiac,cerebral,liver,kidney,lung, endocrine disease or sepsis.
- Long term used hormone or adrenal suppression.
- Allergy to trial drug or other contraindication.
- Difficult airway occurred before,or difficult airway possibly occurred and difficult to extubation.
Show all 12Show fewer
- Abuse of narcotic analgesia or suspected.
- Neuromuscular diseases.
- Mentally unstable or has a mental illness.
- Malignant Hyperthermia.
- Pregnant or breast-feeding women.
- Attended other trial past 30 days. -
About this study
Official title: The Comparison of Efficacy and Safety of Target Controlled Infusion of Propofol or Etomidate at General Anesthesia in Geriatric Patients --A Randomized Controlled Trial.
Compare the efficacy and safety of closed-loop target controlled infusion of propofol or etomidate at general anesthesia in geriatric patients
- Conditions
- Adrenal Suppression, Hemodynamic Instability
- Being tested
- Remifentanil, Cisatracurium, Sufentanil, Bispectral index(BIS) monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Ruijie
- Remifentanil 0.1-0.2μg/ ( kg•min) is continuously pumped at steady speed for analgesia for induction and maintenance of anesthesia.
- Remifentanil is stopped before skin closure
CisatracuriumDrug
- Cisatracurium 0.15 mg/kg for induction and 0.12 mg/kg/h continuous infusion for maintenance of anesthesia.
- Cisatracurium is stopped before skin closure.
SufentanilDrug
Before skin closure, remifentanil is stopped and sufentanyl 0.1μg/kg is given by intravenous injection.
Bispectral index(BIS) monitorDevice
BiS is maintained at 40-60 during anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | Target controlled infusion propofol, the effect compartment concentration is 3-4μg/ ml for induction and maintenance of anesthesia. Receives: Drug: Remifentanil; Drug: Cisatracurium; Drug: Sufentanil; Device: Bispectral index(BIS) monitor |
| Etomidate | Experimental | Target controlled infusion etomidate, the effect compartment concentration is 0.5-1.0μg/ ml for induction and maintenance of anesthesia. Receives: Drug: Remifentanil; Drug: Cisatracurium; Drug: Sufentanil; Device: Bispectral index(BIS) monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect Compartment Concentration
The effect compartment concentration of etomidate or propofol are recorded at three time points,including time that patient's loss of eyelash reflex,after 30 minutes of loss of eyelash reflex and when the patient is awake （call then open their eyes).
Measured: From the beginning of induction to paitens'left of PACU, up to 4 hours
Secondary outcomes (3)
vital signs
Systolic blood pressure, diastolic blood pressure, heart rate, respiration rate, pulse oxygen saturation recorded every 5 minutes during the operation.
Measured: From the beginning of induction to skin closure, up to 3 hours
The amount of drugs
The amount of narcotics, sedation and muscle relaxation used in general anesthesia arr recorded when the operation is finished.
Measured: From the beginning of induction to skin closure, up to 3 hours
Adrenal function
- 3 ml blood sample is collected at 5 time points including before induction,30 minutes,2 hours,24 hours, 48 hours after induction;
- to examine the concentration of Cortisol, Aldosterone and ACTH in serum:
Measured: From entering the operating room to 48 h after induction of anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal SuppressionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Medical Association
- Responsible party
- Sponsor
- Investigators
- He Jiaxuan, Principal investigator, Department of Anesthesia, Second Affiliated Hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111265
- Sponsor's protocol ID
- SAHXJTUA01
- Status last verified
- Apr 2014
- First submitted
- 9 Apr 2014
- Last updated
- 14 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Efficacy and Safety of Target Controlled Infusion of Propofol or Etomidate at General Anesthesia in Geriatric Patients --A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02111265
- Acronym / sponsor ID
- SAHXJTUA01
- Conditions
- Adrenal Suppression, Hemodynamic Instability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Chinese Medical Association
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 11 Apr 2014 (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.
Compare the efficacy and safety of closed-loop target controlled infusion of propofol or etomidate at general anesthesia in geriatric patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: Remifentanil, Drug: Cisatracurium, Drug: Sufentanil, Device: Bispectral index(BIS) monitorTarget controlled infusion propofol, the effect compartment concentration is 3-4μg/ ml for induction and maintenance of anesthesia. |
| Etomidate | Experimental | Drug: Remifentanil, Drug: Cisatracurium, Drug: Sufentanil, Device: Bispectral index(BIS) monitorTarget controlled infusion etomidate, the effect compartment concentration is 0.5-1.0μg/ ml for induction and maintenance of anesthesia. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent.
- Scheduled for Endotracheal intubated and general anesthesia for general surgery patients.
- Age 60-75 yrs.
- American Society of Anesthesia (ASA) classification I-II.
- Expected time of surgery is less than 3 hours. -
Key exclusion criteria (12 listed)
- Body mass index is more than 36kg/m2.
- Systolic blood pressure≥180 mm Hg or <90 mm Hg，diastolic blood pressure≥110 mm Hg or < 60 mm Hg.
- Serious cardiac,cerebral,liver,kidney,lung, endocrine disease or sepsis.
- Long term used hormone or adrenal suppression.
- Allergy to trial drug or other contraindication.
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 |
|---|---|---|
| RemifentanilAlso: Ruijie1. Remifentanil 0.1-0.2μg/ ( kg•min) is continuously pumped at steady speed for analgesia for induction and maintenance of anesthesia. 2. Remifentanil is stopped before skin closure | Drug | Etomidate, Propofol |
| Cisatracurium1. Cisatracurium 0.15 mg/kg for induction and 0.12 mg/kg/h continuous infusion for maintenance of anesthesia. 2. Cisatracurium is stopped before skin closure. | Drug | Etomidate, Propofol |
| SufentanilBefore skin closure, remifentanil is stopped and sufentanyl 0.1μg/kg is given by intravenous injection. | Drug | Etomidate, Propofol |
| Bispectral index(BIS) monitorBiS is maintained at 40-60 during anesthesia. | Device | Etomidate, Propofol |
Primary outcome
Effect Compartment Concentration
Time frame: From the beginning of induction to paitens'left of PACU, up to 4 hours
The effect compartment concentration of etomidate or propofol are recorded at three time points,including time that patient's loss of eyelash reflex,after 30 minutes of loss of eyelash reflex and when the patient is awake （call then open their eyes).
3 secondary outcomes
vital signs
Time frame: From the beginning of induction to skin closure, up to 3 hours
The amount of drugs
Time frame: From the beginning of induction to skin closure, up to 3 hours
Adrenal function
Time frame: From entering the operating room to 48 h after induction of anesthesia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2014.
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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.
He Jiaxuan principal investigator
Department of Anesthesia, Second Affiliated Hospital of Xi'an Jiaotong University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil, Cisatracurium and Sufentanil in people with Adrenal Suppression and Hemodynamic Instability, run by Second Affiliated Hospital of Xi'an Jiaotong University.
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 12 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 14 Apr 2014. 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.
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?
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?
Effect Compartment Concentration (time frame: From the beginning of induction to paitens'left of PACU, up to 4 hours). 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 14 Apr 2014.