Monitoring, IntraoperativeNCT01717521
Effects of IV Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris
An observational study of Monitoring, Intraoperative, run by University of Washington at 1 site in United States.
Trial summary
This study evaluates effects of the analgesic ketamine on ANI measurements (Anti Nociceptive Index) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Monitoring, Intraoperative
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2012
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women undergoing gynecological/abdominal surgery
Who may be able to join
- ASA status I, II, or III
- 18 years or older
- Receiving GA with uncomplicated routine intubation
- Ability to provide informed consent
- English-speaking
Who cannot join
- Presence of coronary artery disease, cardiac arrhythmias, or ketamine allergy
- Patient refusal
- History of substance abuse
- Patients taking psychotropic and/or opiate drugs
- Having a history of psychiatric diseases or psychological problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Intravenous Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris Device
This study evaluates effects of the analgesic ketamine on ANI measurements (Anti Nociceptive Index)
Read the detailed description
Researchers at the University of Washington are doing this study to find out if a commonly used anesthetic affects patients Analgesia Nociception Index (level of pain relief) during abdominal hysterectomy under general anesthesia.
The investigators will administer routine anesthesia care including Ketamine, a commonly used anesthetic, during the patients surgery. During the patients surgery, the investigators will monitor the patients level of pain relief using the PhysioDoloris monitor, which monitors the routinely used EKG monitor. Though not yet FDA approved, the PhysioDoloris is completely non-invasive and collects data from the EKG monitor.
- Conditions
- Monitoring, Intraoperative
- Keywords
- intraoperative monitoring, hysterectomy, robotic-assisted, abdominal gynecological surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean ANI Changes After Intubation
ANI stands for Analgesia Nociception Index. Its a dimension less number computed by a pain monitor ranging from 0-100. An index of 100 means absent pain, and the number decreases as pain increases. ANI was measured pre- and post- Intubation
Measured: Before vs after intubation
Mean ANI Changes 3 Min After Ketamine Bolus
ANI was measured pre- and post- i.v. ketamine administration
Measured: Before vs 3 min after Ketamine adminstration
Mean ANI Changes 5 Min After Ketamine Bolus
ANI was measured pre- and post- i.v. ketamine administration
Measured: Before vs 5 min after Ketamine adminstration
Mean ANI Changes After Skin Incision
ANI was measured pre- and post- skin incision
Measured: Before vs after skin incision
Secondary outcomes (9)
Mean BIS Changes After Intubation
BIS was measured pre- and post-intubation.
BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).
- 100-90: awake and responding appropriately to verbal stimulation
- 80-70: responsive to loud commands or mild shaking
- 60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall
- <40: deep hypnotic state; possible protective responses still intact
- <20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact
- 0: totally suppressed EEG (flat line)
Measured: Before vs after intubation
Mean BIS Changes 3 Min After Ketamine Bolus
BIS was measured pre- and post-Ketamine administration.
BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).
- 100-90: awake and responding appropriately to verbal stimulation
- 80-70: responsive to loud commands or mild shaking
- 60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall
- <40: deep hypnotic state; possible protective responses still intact
- <20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact
- 0: totally suppressed EEG (flat line)
Measured: Before vs 3 min after Ketamine adminstration
Mean BIS Changes After Skin Incision
BIS was measured pre- and post-skin incision.
BIS, Bispectral index, is an indication of anesthesia depth and measured by a monitor during surgery (0-100 scale, range described below). Depth of sedation is calculated by measuring cerebral electric activity via an electroencephalogram (EEG).
- 100-90: awake and responding appropriately to verbal stimulation
- 80-70: responsive to loud commands or mild shaking
- 60-40: unresponsive to verbal stimulus; general anesthesia obtained with a low chance for explicit recall
- <40: deep hypnotic state; possible protective responses still intact
- <20: burst suppression (EEG pattern characterized by cycles of high-voltage electrical movement alternating with cycles of no activity in the brain); respiratory drive is limited, but possible protective responses still intact
- 0: totally suppressed EEG (flat line)
Measured: Before vs after skin incision
Mean Heart Rate Change After Intubation
Heart rate assessed by continuous pulse oximetry. Heart rate was measured pre- and post-intubation.
Measured: Before vs after intubation
Mean Heart Rate Change 3 Min After Ketamine Bolus
Heart rate was measured pre- and post- Ketamine administration
Measured: Before vs 3 min after Ketamine adminstration
Mean Heart Rate Change After Skin Incision
Heart rate was measured pre- and post-skin incision.
Measured: Before vs after skin incision
Change in Mean Arterial Pressure After Intubation
MAP or mean arterial pressure is the average blood pressure of an individual and is measured non-invasively during surgery. MAP was measured pre- and post-intubation.
Measured: Before vs after intubation
Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus
MAP was measured pre- and post-ketamine administration
Measured: Before vs 3 min after Ketamine adminstration
Mean MAP Changes After Skin Incision
MAP was measured pre- and post- skin incision.
Measured: Before vs after skin incision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionDec 2012
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 Monitoring, IntraoperativeStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurent Bollag, University of Washington
- Investigators
- Laurent Bollag, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717521
- Sponsor's protocol ID
- 42398
- Status last verified
- Jun 2019
- First submitted
- 10 Oct 2012
- Last updated
- 5 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intravenous Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris Device
- ClinicalTrials.gov ID
- NCT01717521
- Acronym / sponsor ID
- 42398
- Conditions
- Monitoring, Intraoperative
- Keywords
- intraoperative monitoring, hysterectomy, robotic-assisted, abdominal gynecological surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Posted 5 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates effects of the analgesic ketamine on ANI measurements (Anti Nociceptive Index)
Detailed description
Researchers at the University of Washington are doing this study to find out if a commonly used anesthetic affects patients Analgesia Nociception Index (level of pain relief) during abdominal hysterectomy under general anesthesia.
The investigators will administer routine anesthesia care including Ketamine, a commonly used anesthetic, during the patients surgery. During the patients surgery, the investigators will monitor the patients level of pain relief using the PhysioDoloris monitor, which monitors the routinely used EKG monitor. Though not yet FDA approved, the PhysioDoloris is completely non-invasive and collects data from the EKG monitor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing gynecological/abdominal surgery
Key inclusion criteria (5 listed)
- ASA status I, II, or III
- 18 years or older
- Receiving GA with uncomplicated routine intubation
- Ability to provide informed consent
- English-speaking
Key exclusion criteria (5 listed)
- Presence of coronary artery disease, cardiac arrhythmias, or ketamine allergy
- Patient refusal
- History of substance abuse
- Patients taking psychotropic and/or opiate drugs
- Having a history of psychiatric diseases or psychological problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean ANI Changes After Intubation
Time frame: Before vs after intubation
ANI stands for Analgesia Nociception Index. Its a dimension less number computed by a pain monitor ranging from 0-100. An index of 100 means absent pain, and the number decreases as pain increases. ANI was measured pre- and post- Intubation
Mean ANI Changes 3 Min After Ketamine Bolus
Time frame: Before vs 3 min after Ketamine adminstration
ANI was measured pre- and post- i.v. ketamine administration
Mean ANI Changes 5 Min After Ketamine Bolus
Time frame: Before vs 5 min after Ketamine adminstration
ANI was measured pre- and post- i.v. ketamine administration
Mean ANI Changes After Skin Incision
Time frame: Before vs after skin incision
ANI was measured pre- and post- skin incision
9 secondary outcomes
Mean BIS Changes After Intubation
Time frame: Before vs after intubation
Mean BIS Changes 3 Min After Ketamine Bolus
Time frame: Before vs 3 min after Ketamine adminstration
Mean BIS Changes After Skin Incision
Time frame: Before vs after skin incision
Mean Heart Rate Change After Intubation
Time frame: Before vs after intubation
Mean Heart Rate Change 3 Min After Ketamine Bolus
Time frame: Before vs 3 min after Ketamine adminstration
Mean Heart Rate Change After Skin Incision
Time frame: Before vs after skin incision
Change in Mean Arterial Pressure After Intubation
Time frame: Before vs after intubation
Change in Mean Arterial Pressure After 3 Min After Ketamine Bolus
Time frame: Before vs 3 min after Ketamine adminstration
Mean MAP Changes After Skin Incision
Time frame: Before vs after skin incision
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Laurent Bollag, MD principal investigator
University of Washington
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 Monitoring, Intraoperative, run by University of Washington 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 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 5 Aug 2019. 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?
Yes. Results are posted in the registry (first posted 5 Aug 2019). 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?
Mean ANI Changes After Intubation (time frame: Before vs after intubation). The study lists 4 primary outcomes in all. 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 5 Aug 2019.