Benign/Malignant NeoplasmNCT01618539
Correlation of Bispectral Index Score and Total Intravenous Anesthesia (TIVA)
An observational study of Benign/Malignant Neoplasm and Long Bone Fracture, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
General Anesthesia is usually produced by an intravenous agent and then maintained with a breathing agent till the surgery is completed. However, there is a recent trend to produce and maintain general anesthesia solely with an intravenous agent, such as propofol, in view of its advantages. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Benign/Malignant Neoplasm, Long Bone Fracture
- What is being tested?
- propofol
- Type of treatment
- Injection or infusion
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Sep 2014
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: male and female
Who may be able to join
- 18-65 undergoing orthopedic or gyn surgery
- ASA status I-III
Who cannot join
- pregnant patients
- uncontrolled hypertension with B/P above 180/100
- unstable angina
- end stage liver or kidney disease
- Pts anticipated to be placed in prone position for surgery
- Documented allergy to propofol, eggs, soy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study to Establish a Correlation Between Infusion Rate of Propofol and Bispectral Index (BIS) in Patients Receiving Total Intravenous Anesthesia (TIVA)
General Anesthesia is usually produced by an intravenous agent and then maintained with a breathing agent till the surgery is completed. However, there is a recent trend to produce and maintain general anesthesia solely with an intravenous agent, such as propofol, in view of its advantages. This delivery method is called Total Intravenous Anesthesia (TIVA). The depth of general anesthesia can be measured by an anesthetic depth monitoring device called Bispectral Index (BIS). The use of BIS to determine the depth of anesthesia has been well established whenever a breathing agent is used to maintain general anesthesia. However, the validity of using BIS with TIVA has not been adequately investigated. This study will compare the BIS values at different doses of TIVA in order to establish any correlation between the two. If such a correlation is established, BIS monitoring can safely be recommended to determine anesthetic depth under TIVA.
Read the detailed description
Pre-anesthetic Management: This research will be initiated after receiving an approval from the Institution Review Board, and an informed written consent will be obtained from each patient. Forty patients in the age range 18-65 years and presenting for elective orthopedic or gynecological procedures will be recruited. Both male and female patients will be considered. Only patients with American Society of Anesthesiologists (ASA) physical status I, II and III will be included. Patients who are pregnant and those with uncontrolled hypertension with BP above 180/100, unstable angina, chronic obstructive lung disease requiring oxygen therapy at home, and end-stage liver and kidney diseases will be excluded. In addition, orthopedic surgery that needs the patient in prone position will not be eligible for this investigation. Patients who have a medication allergy to propofol and food allergy to egg and soy, since egg lecithin and soy milk are constituents of propofol preparation, will be excluded. In order to have a complete data collection, only surgical procedures scheduled to last more than three hours will be considered for this study.
Anesthetic Management: Routine anesthetic care, such as intravenous line placement and American Society of Anesthesiologists' standard monitoring, will be applied to all patients. In addition, a non-invasive Bispectral Index (BIS) sensor will be placed on patient's forehead and connected to its monitor. Midazolam (25mcg/kg) and fentanyl (1mcg/kg) will be administered to establish preanesthetic sedation and analgesia, respectively. Lidocaine 40mg will be given to attenuate propofol-induced injection pain. Thereafter, Total Intravenous Anesthesia (TIVA) will be induced with propofol (2mg/kg), and tracheal intubation facilitated with a neuromuscular blocking agent chosen by the attending anesthesiologist. The skeletal muscle relaxation will be maintained as needed for the surgical procedure. The TIVA will be maintained with propofol infusion, for approximately half-hour, at 160mcg/kg/min with minor adjustment, as needed, to maintain patient's vital signs within ± 20% of the baseline. Once a steady state is established, propofol infusion rate will be reduced to 140mcg/kg/min and maintained for approximately 15-30 min, following which the infusion rate will be increased to 180mcg/kg/min and maintained for the same period of time. Thereafter, the propofol infusion rate will be returned to 160mcg/kg/min. This exercise will be repeated at 120mcg/kg/min and 200mcg/kg/min if patient's vital signs permit. In addition, remifentanil at an infusion rate of 0.02 - 0.2mcg/kg/min will be administered to provide surgical analgesia during the general anesthetic period. The infusion rate of remifentanil will be tailored to the demands of the surgical stimulation. During the study period, the attending anesthesiologist will have the option to deviate from the study protocol and adjust the propofol infusion rate, as needed, to maintain patient's vital signs within ± 20% of the baseline if such a need arises. An independent observer will continuously monitor the BIS values at all time frames. Following the study period needed to collect the required data, the attending anesthesiologist will have the option to continue general anesthesia with either TIVA or with the traditional inhalational anesthetic. The reversal of the neuromuscular blockade and subsequent tracheal extubation, at the conclusion of surgery, will be performed using the customary criteria employed in anesthetic practice. In addition, the routine protocols used for surgical infection prevention and attenuation of postoperative pain and vomiting will be followed.
- Conditions
- Benign/Malignant Neoplasm, Long Bone Fracture
- Being tested
- propofol
- Keywords
- Total intravenous anesthesia, Bispectral Index Score
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
varying intravenous dosages
What is being measured
The primary outcome is the main question the study is designed to answer.
BIS response to varying TIVA dosages
Correlation between various infusion rates of propofol administered during TIVA and BIS values during the first 3 hours of the operative procedure
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: PI retired prior to final N number reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign/Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Shulman, MD, Principal investigator, Rutgers/NJMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618539
- Sponsor's protocol ID
- 2011001109
- Status last verified
- Jul 2016
- First submitted
- 5 Jun 2012
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Establish a Correlation Between Infusion Rate of Propofol and Bispectral Index (BIS) in Patients Receiving Total Intravenous Anesthesia (TIVA)
- ClinicalTrials.gov ID
- NCT01618539
- Acronym / sponsor ID
- 2011001109
- Conditions
- Benign/Malignant Neoplasm, Long Bone Fracture
- Keywords
- Total intravenous anesthesia, Bispectral Index Score
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI retired prior to final N number reached
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Jun 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.
General Anesthesia is usually produced by an intravenous agent and then maintained with a breathing agent till the surgery is completed. However, there is a recent trend to produce and maintain general anesthesia solely with an intravenous agent, such as propofol, in view of its advantages. This delivery method is called Total Intravenous Anesthesia (TIVA). The depth of general anesthesia can be measured by an anesthetic depth monitoring device called Bispectral Index (BIS). The use of BIS to determine the depth of anesthesia has been well established whenever a breathing agent is used to maintain general anesthesia. However, the validity of using BIS with TIVA has not been adequately investigated. This study will compare the BIS values at different doses of TIVA in order to establish any correlation between the two. If such a correlation is established, BIS monitoring can safely be recommended to determine anesthetic depth under TIVA.
Detailed description
Pre-anesthetic Management: This research will be initiated after receiving an approval from the Institution Review Board, and an informed written consent will be obtained from each patient. Forty patients in the age range 18-65 years and presenting for elective orthopedic or gynecological procedures will be recruited. Both male and female patients will be considered. Only patients with American Society of Anesthesiologists (ASA) physical status I, II and III will be included. Patients who are pregnant and those with uncontrolled hypertension with BP above 180/100, unstable angina, chronic obstructive lung disease requiring oxygen therapy at home, and end-stage liver and kidney diseases will be excluded. In addition, orthopedic surgery that needs the patient in prone position will not be eligible for this investigation. Patients who have a medication allergy to propofol and food allergy to egg and soy, since egg lecithin and soy milk are constituents of propofol preparation, will be excluded. In order to have a complete data collection, only surgical procedures scheduled to last more than three hours will be considered for this study.
Anesthetic Management: Routine anesthetic care, such as intravenous line placement and American Society of Anesthesiologists' standard monitoring, will be applied to all patients. In addition, a non-invasive Bispectral Index (BIS) sensor will be placed on patient's forehead and connected to its monitor. Midazolam (25mcg/kg) and fentanyl (1mcg/kg) will be administered to establish preanesthetic sedation and analgesia, respectively. Lidocaine 40mg will be given to attenuate propofol-induced injection pain. Thereafter, Total Intravenous Anesthesia (TIVA) will be induced with propofol (2mg/kg), and tracheal intubation facilitated with a neuromuscular blocking agent chosen by the attending anesthesiologist. The skeletal muscle relaxation will be maintained as needed for the surgical procedure. The TIVA will be maintained with propofol infusion, for approximately half-hour, at 160mcg/kg/min with minor adjustment, as needed, to maintain patient's vital signs within ± 20% of the baseline. Once a steady state is established, propofol infusion rate will be reduced to 140mcg/kg/min and maintained for approximately 15-30 min, following which the infusion rate will be increased to 180mcg/kg/min and maintained for the same period of time. Thereafter, the propofol infusion rate will be returned to 160mcg/kg/min. This exercise will be repeated at 120mcg/kg/min and 200mcg/kg/min if patient's vital signs permit. In addition, remifentanil at an infusion rate of 0.02 - 0.2mcg/kg/min will be administered to provide surgical analgesia during the general anesthetic period. The infusion rate of remifentanil will be tailored to the demands of the surgical stimulation. During the study period, the attending anesthesiologist will have the option to deviate from the study protocol and adjust the propofol infusion rate, as needed, to maintain patient's vital signs within ± 20% of the baseline if such a need arises. An independent observer will continuously monitor the BIS values at all time frames. Following the study period needed to collect the required data, the attending anesthesiologist will have the option to continue general anesthesia with either TIVA or with the traditional inhalational anesthetic. The reversal of the neuromuscular blockade and subsequent tracheal extubation, at the conclusion of surgery, will be performed using the customary criteria employed in anesthetic practice. In addition, the routine protocols used for surgical infection prevention and attenuation of postoperative pain and vomiting will be followed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- male and female
Key inclusion criteria (2 listed)
- 18-65 undergoing orthopedic or gyn surgery
- ASA status I-III
Key exclusion criteria (6 listed)
- pregnant patients
- uncontrolled hypertension with B/P above 180/100
- unstable angina
- end stage liver or kidney disease
- Pts anticipated to be placed in prone position for surgery
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 |
|---|---|---|
| propofolvarying intravenous dosages | Drug | – |
Primary outcome
BIS response to varying TIVA dosages
Time frame: 3 hours
Correlation between various infusion rates of propofol administered during TIVA and BIS values during the first 3 hours of the operative procedure
Results and safety
The study was stopped early (reason given: PI retired prior to final N number reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Steven Shulman, MD principal investigator
Rutgers/NJMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign/Malignant Neoplasm and Long Bone Fracture, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 14 Mar 2017. 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 United States. 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?
The study was stopped early (reason given: PI retired prior to final N number reached). 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?
BIS response to varying TIVA dosages (time frame: 3 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 Mar 2017.