Spine DiseasesNCT02174913
Awakening in Spine Surgery: A Comparison Between Clinical Signs and Bispectral Index
A study testing bispectral index, Fentanyl and Atracurium in people with Spine Diseases, run by Mahidol University at 1 site in Thailand.
Trial summary
BIS is one of several equipments used to monitor depth of anesthesia.Some studies found BIS can reduce total propofol dose when being used with target controlled infusion (TCI).The objective is to compare awakening time after spine surgery between using clinical signs and bispectral index (BIS) guided target… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spine Diseases
- What is being tested?
- bispectral index, Fentanyl and Atracurium
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteThailand
- Study dates
- May 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- spine surgery with neurophysiology monitoring
- ASA 1-3
- elective case
- cooperate patients
- Not receive drugs interfere with EEG
Who cannot join
- unstable hemodynamics
- liver disease
- propofol allergy
- BMI > 30
- complete cord lesion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Awakening in Spine Surgery Patients Having Neurophysiologic Monitoring: A Comparison Study Between Clinical Signs and Bispectral Index (BIS) Guided Target Controlled Infusion(TCI) of Propofol
BIS is one of several equipments used to monitor depth of anesthesia.Some studies found BIS can reduce total propofol dose when being used with target controlled infusion (TCI).The objective is to compare awakening time after spine surgery between using clinical signs and bispectral index (BIS) guided target controlled infusion(TCI) of propofol in patients having neurophysiologic monitoring.
Read the detailed description
34 patients undergoing spine surgery will be enrolled and randomly assigned into two groups. We exclude patients who age under 18 and over 80 years, preoperative hemodynamics instability, propofol allergy, receiving drugs interfered with EEG, liver disease, Body Mass Index (BMI) over 30 kg/m2. Before induction the patient will be given 0.9% Sodium Chloride (NaCl) or acetate Ringer solution 7 ml/kg. Standard monitorings are used to all patients.
Control group will receive fentanyl 1 mcg/kg and then fentanyl infusion 1 mcg/kg/hr and propofol TCI target 3-7 mcg/ml until asleep and then atracurium 0.5 mg/kg was given to facilitate endotracheal intubation. The patients will be ventilated with air:oxygen 1:1 L. The TCI propofol will be adjusted by clinical monitoring. If the patient has minor movement, the propofol TCI will be increased incrementally to 0.5 mcg/ml higher level but if major movement occurs the dose will be increased to1.0 mcg/ml higher. When hypotension occurs, this will be treated by fluid loading 200 ml in 10 min if it is not improved, then ephedrine or norepinephrine will be given and the TCI dose will be decreased by 0.5 mcg/ml lower level but not lower than 3.0 mcg/ml. Hypertension will be treated by fentanyl bolus 0.5 mcg/kg and increasing TCI dose to 0.5 mcg/ml higher level but not more than 7 mcg/ml. If hypertension persist, the nicardipine or diltiazem will be given.
Intervention group receives fentanyl 1 mcg/kg and then fentanyl infusion 1 mcg/kg/hr and propofol by TCI 3-7 mcg/ml until asleep and then atracurium 0.5 mg/kg was given to facilitate endotracheal intubation. The patients will be ventilated with air:oxygen 1:1 L. Propofol will be adjusted by BIS monitoring. If the movement occurs and BIS 40-60, fentanyl 0.5 mcg/kg will be given, BIS > 60, TCI dose will be increased 0.5 mcg/ml higher level until BIS 40-60. When hypotension occurs, if BIS 40-60, will be treated by load fluid 200 ml in 10 mins, then ephedrine or norepinephrine will be given, If BIS < 40 the TCI dose will decrease 0.5 mcg/ml but not lower than 3.0 mcg/ml. Hypertension occurs, if BIS > 60 will be treated by fentanyl bolus 0.5 mcg/kg and TCI dose will be increased 0.5 mcg/ml higher level but not more than 7 mcg/ml if not improved, nicardipine or diltiazem will be given. if BIS 40-60, nicardipine or diltiazem will be given.
This outcome measures are extubation time,total propofol dose.
- Conditions
- Spine Diseases
- Being tested
- bispectral index, Target controlled infusion of propofol, Fentanyl, Atracurium
- Keywords
- Awakening time, Bispectral index, clinical signs, neurophysiologic monitoring, spine surgery
- Medical subject headings
- Spinal Diseases, Signs and Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bispectral indexDevice
Bispectral index (BIS) is one of several technologies used to monitor depth of anesthesia.
Target controlled infusion of propofolDrug
Also called TCI propofol
TCI propofol (3-7 mcg/dL, Schnider model) is used for total intravenous anesthesia in both groups
FentanylDrug
Fentanyl 1-2 mcg/kg iv for induction and then 0.5-1.0 mcg/kg/hr infusion is used for analgesic.
AtracuriumDrug
Also called Tracrium
Atracurium 0.6 mg/kg is used for endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| bispectral index/TCI propofol/fentanyl | Active comparator | Bispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation. Fentanyl is used for analgesia and atracurium is used for tracheal intubation. Receives: Device: bispectral index; Drug: Target controlled infusion of propofol; Drug: Fentanyl; Drug: Atracurium |
| clinical signs/TCI propofol/fentanyl | Placebo comparator | Clinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol. Fentanyl is used for analgesia and atracurium is used for tracheal intubation. Receives: Drug: Target controlled infusion of propofol; Drug: Fentanyl; Drug: Atracurium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation Time
Awakening time from finished operation to endotracheal extubation.
Measured: 4 hr
Secondary outcomes (1)
Total Propofol Dosage
total propofol dosage = propofol dose from start to end of the operation
Measured: From start anesthesia to finish operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spine DiseasesStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manee Raksakietisak, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174913
- Sponsor's protocol ID
- 099/2557
- Status last verified
- Jun 2020
- First submitted
- 12 Jun 2014
- Last updated
- 13 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awakening in Spine Surgery Patients Having Neurophysiologic Monitoring: A Comparison Study Between Clinical Signs and Bispectral Index (BIS) Guided Target Controlled Infusion(TCI) of Propofol
- ClinicalTrials.gov ID
- NCT02174913
- Acronym / sponsor ID
- 099/2557
- Conditions
- Spine Diseases
- Keywords
- Awakening time, Bispectral index, clinical signs, neurophysiologic monitoring, spine surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Posted 13 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BIS is one of several equipments used to monitor depth of anesthesia.Some studies found BIS can reduce total propofol dose when being used with target controlled infusion (TCI).The objective is to compare awakening time after spine surgery between using clinical signs and bispectral index (BIS) guided target controlled infusion(TCI) of propofol in patients having neurophysiologic monitoring.
Detailed description
34 patients undergoing spine surgery will be enrolled and randomly assigned into two groups. We exclude patients who age under 18 and over 80 years, preoperative hemodynamics instability, propofol allergy, receiving drugs interfered with EEG, liver disease, Body Mass Index (BMI) over 30 kg/m2. Before induction the patient will be given 0.9% Sodium Chloride (NaCl) or acetate Ringer solution 7 ml/kg. Standard monitorings are used to all patients.
Control group will receive fentanyl 1 mcg/kg and then fentanyl infusion 1 mcg/kg/hr and propofol TCI target 3-7 mcg/ml until asleep and then atracurium 0.5 mg/kg was given to facilitate endotracheal intubation. The patients will be ventilated with air:oxygen 1:1 L. The TCI propofol will be adjusted by clinical monitoring. If the patient has minor movement, the propofol TCI will be increased incrementally to 0.5 mcg/ml higher level but if major movement occurs the dose will be increased to1.0 mcg/ml higher. When hypotension occurs, this will be treated by fluid loading 200 ml in 10 min if it is not improved, then ephedrine or norepinephrine will be given and the TCI dose will be decreased by 0.5 mcg/ml lower level but not lower than 3.0 mcg/ml. Hypertension will be treated by fentanyl bolus 0.5 mcg/kg and increasing TCI dose to 0.5 mcg/ml higher level but not more than 7 mcg/ml. If hypertension persist, the nicardipine or diltiazem will be given.
Intervention group receives fentanyl 1 mcg/kg and then fentanyl infusion 1 mcg/kg/hr and propofol by TCI 3-7 mcg/ml until asleep and then atracurium 0.5 mg/kg was given to facilitate endotracheal intubation. The patients will be ventilated with air:oxygen 1:1 L. Propofol will be adjusted by BIS monitoring. If the movement occurs and BIS 40-60, fentanyl 0.5 mcg/kg will be given, BIS > 60, TCI dose will be increased 0.5 mcg/ml higher level until BIS 40-60. When hypotension occurs, if BIS 40-60, will be treated by load fluid 200 ml in 10 mins, then ephedrine or norepinephrine will be given, If BIS < 40 the TCI dose will decrease 0.5 mcg/ml but not lower than 3.0 mcg/ml. Hypertension occurs, if BIS > 60 will be treated by fentanyl bolus 0.5 mcg/kg and TCI dose will be increased 0.5 mcg/ml higher level but not more than 7 mcg/ml if not improved, nicardipine or diltiazem will be given. if BIS 40-60, nicardipine or diltiazem will be given.
This outcome measures are extubation time,total propofol dose.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bispectral index/TCI propofol/fentanyl | Active comparator | Device: bispectral index, Drug: Target controlled infusion of propofol, Drug: Fentanyl, Drug: AtracuriumBispectral index guides the target controlled infusion of propofol by keeping BIS 40-60 throughout operation. Fentanyl is used for analgesia and atracurium is used for tracheal intubation. |
| clinical signs/TCI propofol/fentanyl | Placebo comparator | Drug: Target controlled infusion of propofol, Drug: Fentanyl, Drug: AtracuriumClinical signs (heart rate, blood pressure and movement) guide target controlled infusion(TCI) of propofol. Fentanyl is used for analgesia and atracurium is used for tracheal intubation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- spine surgery with neurophysiology monitoring
- ASA 1-3
- elective case
- cooperate patients
- Not receive drugs interfere with EEG
Key exclusion criteria (5 listed)
- unstable hemodynamics
- liver disease
- propofol allergy
- BMI > 30
- complete cord lesion
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 |
|---|---|---|
| bispectral indexBispectral index (BIS) is one of several technologies used to monitor depth of anesthesia. | Device | bispectral index/TCI propofol/fentanyl |
| Target controlled infusion of propofolAlso: TCI propofolTCI propofol (3-7 mcg/dL, Schnider model) is used for total intravenous anesthesia in both groups | Drug | bispectral index/TCI propofol/fentanyl, clinical signs/TCI propofol/fentanyl |
| FentanylFentanyl 1-2 mcg/kg iv for induction and then 0.5-1.0 mcg/kg/hr infusion is used for analgesic. | Drug | bispectral index/TCI propofol/fentanyl, clinical signs/TCI propofol/fentanyl |
| AtracuriumAlso: TracriumAtracurium 0.6 mg/kg is used for endotracheal intubation | Drug | bispectral index/TCI propofol/fentanyl, clinical signs/TCI propofol/fentanyl |
Primary outcome
Extubation Time
Time frame: 4 hr
Awakening time from finished operation to endotracheal extubation.
1 secondary outcome
Total Propofol Dosage
Time frame: From start anesthesia to finish operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Manee Raksakietisak, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bispectral index, Fentanyl and Atracurium in people with Spine Diseases, run by Mahidol University at 1 site in Thailand.
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 5 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 13 Jul 2020. 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 Thailand. 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?
Yes. Results are posted in the registry (first posted 13 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Extubation Time (time frame: 4 hr). 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 13 Jul 2020; AzTrials last refreshed its copy on 7 Nov 2026.