Bolus Versus Infusion Ketamine, Anesthesia Gas ConsumptionPhase 4KETABISNCT03781635
Comparison of BIS Index Variations: Bolus Versus Infusion Ketamine, and Impact on the Anesthesia Gas Consumption
A Phase 4 study testing bolus of intravenous ketamine and continuous infusion of intravenous ketamine in people with Bolus Versus Infusion Ketamine, Anesthesia Gas Consumption, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
The aim of the present study is to show that i.v. ketamine boluses might lead to significant and clinically relevant BIS index increase that might lead to an increase in anesthesia dosing (halogenous gas) when compared to an i.v. continuous infusion of ketamine without any bolus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bolus Versus Infusion Ketamine, Anesthesia Gas Consumption
- What is being tested?
- bolus of intravenous ketamine and continuous infusion of intravenous ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 25 Sep 2018to 30 Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I to III
- Patients above 18yo
- Gender female or male
- Abdominal general, urological or gynecological surgery with epidural placement
Who cannot join
- BMI <18 or >35
- Chronic neurological or psychiatric disorder or history of stroke
- Use of psychotropic drugs within 2 weeks prior surgery
- Allergy to ketamine or its excipients or any drug of the anesthesia protocol of this study
- Any contra-indication or patient's refusal for epidural placement
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal
Montreal East, Quebec, H1T2M4
About this study
Official title: Comparison of BIS Index Variations When i.v. Low-dose Ketamine is Administered Intraoperatively as Bolus Versus Continuous Infusion and Impact on the Anesthesia Gas Consumption.
The aim of the present study is to show that i.v. ketamine boluses might lead to significant and clinically relevant BIS index increase that might lead to an increase in anesthesia dosing (halogenous gas) when compared to an i.v. continuous infusion of ketamine without any bolus.
Read the detailed description
Hypothesis: The investigators hypothesize that BIS will not vary when ketamine is given as an i.v. infusion whereas BIS index will significantly vary when ketamine is given as intraoperative repeated bolus on an hourly basis. As a consequence, the bolus group might have a higher consumption of halogenous gases to keep BIS within normal values during anesthesia.
Background: ketamine is a pure NMDA-receptor antagonist widely used in anesthesia for its anesthetic and analgesic properties. However, boluses of intravenous ketamine have been reported to increase BIS values. The present study is the first to compare ketamine effect on BIS values when given as an infusion versus repeated boluses.
Objectives: primary objective: to measure the changes in BIS index values (delta BIS) after each bolus of i.v. ketamine 0.25mg.kg-1 given during anesthesia for surgeries lasting more than 3hs, and to demonstrate a significant increase of this BIS index whereas no significant increase is expected when i.v. ketamine is given as a continuous infusion intraoperatively. Secondary objectives: to measure the changes of BIS index values area under the curve when an infusion of i.v. ketamine 0.25mg.kg-1.h-1 is administered to the patient instead of boluses; to evaluate the time in minutes for the BIS index values to return within +/-10% of the pre-bolus values of this BIS index; to evaluate the time in seconds at which the peak of BIS will occur after ketamine bolus; to evaluate the consumption of halogenous gases during the entire surgery and for each hour of anesthesia (T0 = incision = time for first bolus of ketamine or start of ketamine infusion); to evaluate hemodynamic data (all the data from the ventilator and the monitor are recorded and exported per second) in both groups and see if the infusion group shows less hypotension events needing treatment with i.v. phenylephrine to stay within +/-20% of the mean blood pressure baseline; to evaluate the time for awakening, time for extubation, time spent in post-anesthesia care unit (PACU), delirium and cognitive functions in PACU (CAMshort assessment and MOCA).
Methods: REB from CR-HMR will be obtained. 50 patients undergoing elective general, urological, gynecological surgeries will be explained the study at the pre-anesthesia consultation and then fully consented the day of the surgery. Anesthesia protocol will be fully standardized in both the groups. BIS monitoring will be installed before induction of general anesthesia as well as the standard anesthesia monitoring. Randomization into group infusion versus boluses of ketamine will be done prior to the entrance in the OR, the day of the surgery. Ketamine will be given as follows: in the i.v. ketamine infusion group, an infusion of 0.25 mg.kg-1.h-1 is started with an infusion pump and is kept at the same rate until the surgical team starts closing the deep layers of the abdominal incision. Consumption of the infusion pump is noted at T0 (incision) and at each hour during the surgery and when the infusion is discontinued. In the i.v. ketamine bolus group, 0.25mg.kg-1 of ketamine will be first administered at the time of incision (T0) then every single hour for the rest of the surgery. Study starts at anesthesia induction and incision (T0) for ketamine administration and ends when the patient leaves the PACU. Objectives of the study are cited above.
Data analysis: statistical analyses will be done using SAS version 9.4 or higher and will be performed at a two-sided 0.05 significance level.
Significance/Importance: This is the first study that will compare the impact of the classical intraoperative ketamine administered as repeated i.v. boluses versus as a continuous i.v. infusion during major surgeries lasting more than 3 hours.
Study Design: open label study, with two controlled randomized parallel groups
Subject Population: ASA 1 to 3 adult patients scheduled to undergo elective general, urologic or gynecological surgeries.
Sample Size: 50 patients will be evaluated in this study.
Study Duration: 10 months.
Study Center: Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal, Montreal, Quebec, Canada.
Adverse Events: None expected.
- Being tested
- bolus of intravenous ketamine, continuous infusion of intravenous ketamine
- Keywords
- Ketamine, anesthesia, BIS monitoring, epidural, intraoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bolus of intravenous ketamineDrug
low-dose ketamine (0.25mg.kg-1) is administered intraoperatively as bolus at incision (T0) and for each hour of anesthesia untel the end of surgery.
continuous infusion of intravenous ketamineDrug
An infusion of low-dose ketamine (0.25 mg.kg-1.h-1) is started at T0 (incision) with an infusion pump and is kept at the same rate until the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| bolus of intravenous ketamine | Active comparator | A bolus of 0.25mg.kg-1 of ketamine will be first administered at the time of incision (T0) then every single hour for the rest of the surgery. Study starts at incision (T0) for ketamine administration and ends when the surgical team starts closing the deep layers of the abdominal incision. Receives: Drug: bolus of intravenous ketamine |
| continuous infusion of intravenous ketamine | Experimental | An infusion of 0.25 mg.kg-1.h-1 is started at T0 (incision) with an infusion pump and is kept at the same rate until the surgical team starts closing the deep layers of the abdominal incision. Consumption of the infusion pump is noted at T0 (incision) and at each hour during the surgery until the infusion is discontinued. Receives: Drug: continuous infusion of intravenous ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the increase of the BIS index (absolute value between 0 to 100) after each intravenous ketamine bolus
To demonstrate and quantify à significant increase of the BIS index after each bolus of 0.25 mg.kg-1 ketamine given during surgeries lasting 3 hours and more, compared to an equivalent dose of ketamine given as a continuous infusion. Boluses of ketamine will start at T0 = incision and then will be repeated every hour for the duration of the surgery.
Measured: Intraoperative, during anesthesia
Secondary outcomes (13)
Area under the curve of BIS values from T0=incision until end of the anesthesia, value without unit (area under curve)
To compare the BIS index values area under the curve from T0=incision until end of anesthesia when i.v. ketamine 0.25mg.kg-1.h-1 is administered as an infusion or as hourly boluses.
Measured: Intraoperative, during anesthesia
Time for BIS to return within 10% of the baseline values (in minutes)
To evaluate the time in minutes for the BIS index values to return within +/-10% of the values the BIS index had before the bolus of ketamine.
Measured: Intraoperative, during anesthesia
Time to reach the peak of BIS index after intravenous bolus of ketamine
To evaluate the time in seconds at which the peak of BIS will occur after intravenous ketamine bolus 0.25mg/kg.
Measured: Intraoperative, during anesthesia
Evaluation of the consumption of halogenous gases (desflurane) during each hour of anesthesia in ml/kg/h of gas
To evaluate the consumption of halogenous gases (desflurane) during each hour of anesthesia in ml/kg/h.
Measured: Intraoperative, during anesthesia
Evaluation of the consumption of phenylephrine in mcg/kg/h for each hour of anesthesia.
To evaluate the need of intravenous phenylephrine given during each hour of anesthesia in both groups.
Measured: Intraoperative, during anesthesia
Evaluation of the blood pressure during each hour of anesthesia.
To evaluate blood pressure recorded electronically during the whole anesthesia and to evaluate the impact of intravenous bolus of ketamine 0.25mg/kg on blood pressure during the whole hour following each bolus administration (given hourly).
Measured: Intraoperative, during anesthesia
Evaluation of the time in minutes necessary to extubatne the patient at the end of the surgery
To evaluate the time for extubation in minutes at the end of surgery
Measured: End of surgery
Evaluation of the time in minutes to reach an Alerte score of >9 in post-anesthesia care unit
To evaluate the time in minutes to reach an alerte score (this score has no unit) of more than 9.
Measured: In post anesthesia care unit, 2 hours after surgery is done
Evaluation of the MOCA score (score from 0 to 30) in PACU at 15 minutes after arrival in PACU (post-anesthesia care unit)
To evaluate the MOCA score (0 to 30) in PACU at 15minutes after arrival.
Measured: 15 minutes after arrival in PACU
Evaluation of the MOCA score (score from 0 to 30) in PACU at 45 minutes after arrival in PACU (post-anesthesia care unit)
To evaluate the MOCA score (0 to 30) in PACU at 45minutes after arrival.
Measured: 45 minutes after arrival in PACU
Evaluation of the delirium with CAM (Confusion Assessment Method that has NO unit) in PACU at 15 minutes after arrival in PACU (post-anesthesia care unit)
To evaluate the CAM (no unit) in PACU at 15minutes after arrival.
Measured: 15 minutes after arrival in PACU
Evaluation of the delirium with CAM (Confusion Assessment Method that has NO unit) in PACU at 45 minutes after arrival in PACU (post-anesthesia care unit)
To evaluate the CAM (no unit) in PACU at 45minutes after arrival.
Measured: 45 minutes after arrival in PACU
Evaluation of the total time spent in PACU in minutes
Total time in PACU in minutes
Measured: 3 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start25 Sep 2018
- Primary completion29 Mar 2019
- Study completion30 Sep 2019
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 Bolus Versus Infusion Ketamine, Anesthesia Gas ConsumptionStudies 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
- Model description
- Two groups of patients. Randomization into group infusion versus boluses of ketamine according to a randomization list for a total number of patients of 50.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Richebe, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Philippe PR Richebé, MD PhD, Principal investigator, CIUSSS Est de l'ile de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781635
- Sponsor's protocol ID
- 2018-1482
- Acronym
- KETABIS
- Status last verified
- Oct 2021
- First submitted
- 30 Nov 2018
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carrara L, Nault M, Morisson L, Godin N, Idrissi M, Fortier A, Guertin MC, Brulotte V, Fortier LP, Verdonck O, Richebe P. The impact of bolus versus continuous infusion of intravenous ketamine on bispectral index variations and desflurane administration during major surgery: The KETABIS study. Eur J Anaesthesiol. 2021 Nov 1;38(11):1168-1179. doi: 10.1097/EJA.0000000000001588.
PubMed 34474441
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of BIS Index Variations When i.v. Low-dose Ketamine is Administered Intraoperatively as Bolus Versus Continuous Infusion and Impact on the Anesthesia Gas Consumption.
- ClinicalTrials.gov ID
- NCT03781635
- Acronym / sponsor ID
- KETABIS / 2018-1482
- Keywords
- Ketamine, anesthesia, BIS monitoring, epidural, intraoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 20 Dec 2018 (actual)
- 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 of the present study is to show that i.v. ketamine boluses might lead to significant and clinically relevant BIS index increase that might lead to an increase in anesthesia dosing (halogenous gas) when compared to an i.v. continuous infusion of ketamine without any bolus.
Detailed description
Hypothesis: The investigators hypothesize that BIS will not vary when ketamine is given as an i.v. infusion whereas BIS index will significantly vary when ketamine is given as intraoperative repeated bolus on an hourly basis. As a consequence, the bolus group might have a higher consumption of halogenous gases to keep BIS within normal values during anesthesia.
Background: ketamine is a pure NMDA-receptor antagonist widely used in anesthesia for its anesthetic and analgesic properties. However, boluses of intravenous ketamine have been reported to increase BIS values. The present study is the first to compare ketamine effect on BIS values when given as an infusion versus repeated boluses.
Objectives: primary objective: to measure the changes in BIS index values (delta BIS) after each bolus of i.v. ketamine 0.25mg.kg-1 given during anesthesia for surgeries lasting more than 3hs, and to demonstrate a significant increase of this BIS index whereas no significant increase is expected when i.v. ketamine is given as a continuous infusion intraoperatively. Secondary objectives: to measure the changes of BIS index values area under the curve when an infusion of i.v. ketamine 0.25mg.kg-1.h-1 is administered to the patient instead of boluses; to evaluate the time in minutes for the BIS index values to return within +/-10% of the pre-bolus values of this BIS index; to evaluate the time in seconds at which the peak of BIS will occur after ketamine bolus; to evaluate the consumption of halogenous gases during the entire surgery and for each hour of anesthesia (T0 = incision = time for first bolus of ketamine or start of ketamine infusion); to evaluate hemodynamic data (all the data from the ventilator and the monitor are recorded and exported per second) in both groups and see if the infusion group shows less hypotension events needing treatment with i.v. phenylephrine to stay within +/-20% of the mean blood pressure baseline; to evaluate the time for awakening, time for extubation, time spent in post-anesthesia care unit (PACU), delirium and cognitive functions in PACU (CAMshort assessment and MOCA).
Methods: REB from CR-HMR will be obtained. 50 patients undergoing elective general, urological, gynecological surgeries will be explained the study at the pre-anesthesia consultation and then fully consented the day of the surgery. Anesthesia protocol will be fully standardized in both the groups. BIS monitoring will be installed before induction of general anesthesia as well as the standard anesthesia monitoring. Randomization into group infusion versus boluses of ketamine will be done prior to the entrance in the OR, the day of the surgery. Ketamine will be given as follows: in the i.v. ketamine infusion group, an infusion of 0.25 mg.kg-1.h-1 is started with an infusion pump and is kept at the same rate until the surgical team starts closing the deep layers of the abdominal incision. Consumption of the infusion pump is noted at T0 (incision) and at each hour during the surgery and when the infusion is discontinued. In the i.v. ketamine bolus group, 0.25mg.kg-1 of ketamine will be first administered at the time of incision (T0) then every single hour for the rest of the surgery. Study starts at anesthesia induction and incision (T0) for ketamine administration and ends when the patient leaves the PACU. Objectives of the study are cited above.
Data analysis: statistical analyses will be done using SAS version 9.4 or higher and will be performed at a two-sided 0.05 significance level.
Significance/Importance: This is the first study that will compare the impact of the classical intraoperative ketamine administered as repeated i.v. boluses versus as a continuous i.v. infusion during major surgeries lasting more than 3 hours.
Study Design: open label study, with two controlled randomized parallel groups
Subject Population: ASA 1 to 3 adult patients scheduled to undergo elective general, urologic or gynecological surgeries.
Sample Size: 50 patients will be evaluated in this study.
Study Duration: 10 months.
Study Center: Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal, Montreal, Quebec, Canada.
Adverse Events: None expected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups of patients. Randomization into group infusion versus boluses of ketamine according to a randomization list for a total number of patients of 50.
| Arm | Type | Receives |
|---|---|---|
| bolus of intravenous ketamine | Active comparator | Drug: bolus of intravenous ketamineA bolus of 0.25mg.kg-1 of ketamine will be first administered at the time of incision (T0) then every single hour for the rest of the surgery. Study starts at incision (T0) for ketamine administration and ends when the surgical team starts closing the deep layers of the abdominal incision. |
| continuous infusion of intravenous ketamine | Experimental | Drug: continuous infusion of intravenous ketamineAn infusion of 0.25 mg.kg-1.h-1 is started at T0 (incision) with an infusion pump and is kept at the same rate until the surgical team starts closing the deep layers of the abdominal incision. Consumption of the infusion pump is noted at T0 (incision) and at each hour during the surgery until the infusion is discontinued. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I to III
- Patients above 18yo
- Gender female or male
- Abdominal general, urological or gynecological surgery with epidural placement
Key exclusion criteria (5 listed)
- BMI <18 or >35
- Chronic neurological or psychiatric disorder or history of stroke
- Use of psychotropic drugs within 2 weeks prior surgery
- Allergy to ketamine or its excipients or any drug of the anesthesia protocol of this study
- Any contra-indication or patient's refusal for epidural placement
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 |
|---|---|---|
| bolus of intravenous ketaminelow-dose ketamine (0.25mg.kg-1) is administered intraoperatively as bolus at incision (T0) and for each hour of anesthesia untel the end of surgery. | Drug | bolus of intravenous ketamine |
| continuous infusion of intravenous ketamineAn infusion of low-dose ketamine (0.25 mg.kg-1.h-1) is started at T0 (incision) with an infusion pump and is kept at the same rate until the end of surgery | Drug | continuous infusion of intravenous ketamine |
Primary outcome
Evaluation of the increase of the BIS index (absolute value between 0 to 100) after each intravenous ketamine bolus
Time frame: Intraoperative, during anesthesia
To demonstrate and quantify à significant increase of the BIS index after each bolus of 0.25 mg.kg-1 ketamine given during surgeries lasting 3 hours and more, compared to an equivalent dose of ketamine given as a continuous infusion. Boluses of ketamine will start at T0 = incision and then will be repeated every hour for the duration of the surgery.
13 secondary outcomes
Area under the curve of BIS values from T0=incision until end of the anesthesia, value without unit (area under curve)
Time frame: Intraoperative, during anesthesia
Time for BIS to return within 10% of the baseline values (in minutes)
Time frame: Intraoperative, during anesthesia
Time to reach the peak of BIS index after intravenous bolus of ketamine
Time frame: Intraoperative, during anesthesia
Evaluation of the consumption of halogenous gases (desflurane) during each hour of anesthesia in ml/kg/h of gas
Time frame: Intraoperative, during anesthesia
Evaluation of the consumption of phenylephrine in mcg/kg/h for each hour of anesthesia.
Time frame: Intraoperative, during anesthesia
Evaluation of the blood pressure during each hour of anesthesia.
Time frame: Intraoperative, during anesthesia
Evaluation of the time in minutes necessary to extubatne the patient at the end of the surgery
Time frame: End of surgery
Evaluation of the time in minutes to reach an Alerte score of >9 in post-anesthesia care unit
Time frame: In post anesthesia care unit, 2 hours after surgery is done
Evaluation of the MOCA score (score from 0 to 30) in PACU at 15 minutes after arrival in PACU (post-anesthesia care unit)
Time frame: 15 minutes after arrival in PACU
Evaluation of the MOCA score (score from 0 to 30) in PACU at 45 minutes after arrival in PACU (post-anesthesia care unit)
Time frame: 45 minutes after arrival in PACU
Evaluation of the delirium with CAM (Confusion Assessment Method that has NO unit) in PACU at 15 minutes after arrival in PACU (post-anesthesia care unit)
Time frame: 15 minutes after arrival in PACU
Evaluation of the delirium with CAM (Confusion Assessment Method that has NO unit) in PACU at 45 minutes after arrival in PACU (post-anesthesia care unit)
Time frame: 45 minutes after arrival in PACU
Evaluation of the total time spent in PACU in minutes
Time frame: 3 hours after surgery
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 4 Oct 2021.
- Derived from this study: PubMed 34474441Carrara L, Nault M, Morisson L, Godin N, Idrissi M, Fortier A, Guertin MC, Brulotte V, Fortier LP, Verdonck O, Richebe P. The impact of bolus versus continuous infusion of intravenous ketamine on bispectral index variations and desflurane administration during major surgery: The KETABIS study. Eur J Anaesthesiol. 2021 Nov 1;38(11):1168-1179. doi: 10.1097/EJA.0000000000001588.
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.
Philippe PR Richebé, MD PhD principal investigator
CIUSSS Est de l'ile de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bolus of intravenous ketamine and continuous infusion of intravenous ketamine in people with Bolus Versus Infusion Ketamine, Anesthesia Gas Consumption, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
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 4 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 4 Oct 2021. 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 Canada. 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.
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?
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?
Evaluation of the increase of the BIS index (absolute value between 0 to 100) after each intravenous ketamine bolus (time frame: Intraoperative, during anesthesia). 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 NCT03781635, 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 4 Oct 2021.