PainPhase 4NCT02604940
Evaluation of Dexmedetomidine on Post-operative Narcotic Requirements and Pain Scores in Bariatric Patients
A Phase 4 study testing Dexmedetomidine and Normal Saline in people with Pain, run by West Virginia University at 1 site in United States.
Trial summary
The purpose of the study is to determine whether a single bolus dose of dexmedetomidine administered during bariatric surgery has any effect on the amount of narcotic pain medications required by an individual after surgery. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Pain
- What is being tested?
- Dexmedetomidine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 25 Jun 2018
- Phase
- Phase 4
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must be undergoing open bariatric surgery at WVUH-ruby hospital. - They must be ASA class 1, 2 and 3.
- Consented individuals.
- They must be between the age of 18 to 55.
Who cannot join
- History of bradycardia or tachy-brady syndrome HR<45.
- 1st degree heart block or higher.
- Patient refusal.
- On pain medication for any reason for more than 24 hrs within 2 weeks of procedure.
- Allergy to medication.
- History of alcohol or drug abuse.
- History of Cardiac/ liver/ kidney disease
Trial locations and contacts
1 site in 1 country.
United States1 site
WVU Healthcare Ruby Memorial Hospital
Morgantown, West Virginia, 26506
About this study
Official title: Evaluation of a Single Intra-operative Dose of Dexmedetomidine on Post-operative Narcotic Requirements and Pain Scores in Bariatric Surgery Patients
The purpose of the study is to determine whether a single bolus dose of dexmedetomidine administered during bariatric surgery has any effect on the amount of narcotic pain medications required by an individual after surgery. Patients who undergo weight loss surgery will be randomized into two groups - group one -dexmedetomidine group and group two- control group. Both groups will receive a standard anesthetic. Control group will receive weight based dose of fentanyl (standard narcotic pain reliever), intravenous acetaminophen (non-narcotic pain reliever), and 60ml saline. Experimental group will receive weight based dose of fentanyl (standard narcotic pain reliever), intravenous acetaminophen (non-narcotic pain reliever), and dexmedetomidine (given as 1mcg/kg over 10 minutes Intravenous). The Patient will then awaken after surgery in post anesthetic recovery unit and be given a patient controlled analgesia (PCA) pump with hydromorphone (long acting narcotic pain reliever). The amount of hydromorphone used will be recorded by the PACU nurse to the electronic health record ( routine practice) in the two groups and compared for pain medicine requirements. Secondary endpoints will be Visual Analog Score (VAS) pain score, respiratory rate, heart rate, blood pressure oxygen saturation and respiratory rate. All will be recorded at 30,60,90,120 and 240 minutes in the electronic medical record in PACU and compared between the two groups . All the data - Intra operative and Post -operative - Post Anesthesia Care Unit ( PACU) data will be retrieved from the electronic Medical record (EMR). All intra-operative data is automatically computed into the patients EMR. All PACU data is routinely entered into the EMR by the PACU nurse including the PCA data.
Read the detailed description
This study will evaluate the postoperative opioid sparing effects of dexmedetomidine given as single bolus dose intraoperatively. Dexmedetomidine is an agonist of α2-adrenergic receptors sedative medication used by intensive care units and anesthesiologists and is unique in its ability to provide sedation without causing respiratory depression. Recently, it has received attention for its potential for additive analgesia. The study population will be patients undergoing gastric bypass surgery. The study population of bariatric surgery patients was chosen due to high prevalence of sleep apnea and Pickwickian component that can be worsened with opioid analgesia in the postoperative period. The purpose of the study is to test whether the use of a single bolus dose dexmedetomidine in addition to standard dose pain regimen decreases postoperative narcotic requirements when compared to standard dose pain regimen alone. The secondary purpose is to study whether single bolus dose dexmedetomidine reduces respiratory rate, heart rate, systolic and mean blood pressure, patient PCA demand bolus requests and VAS pain scores in the postoperative period. The overall goal of the study is to establish evidence of dexmedetomidine's role in multimodal pain relief in the bariatric surgery population with the possibility of other patient subgroups to follow
- Conditions
- Pain
- Being tested
- Dexmedetomidine, Normal Saline
- Keywords
- Postoperative narcotic requirements, Dexmedetomidine, Bariatric Surgery
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure
Normal SalineDrug
60ml Saline delivered over 10 minutes in OR upon notification of surgical closure.
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Experimental | Experimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure Receives: Drug: Dexmedetomidine |
| Normal Saline | Active comparator | Control group will receive Normal saline over 15 minutes at the beginning of surgical closure Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of Narcotic Utilized by Patient for Pain in Milligrams at 240 Minutes
Amount of narcotic delivered to patient by Patient Controlled Analgesia (PCA)Pump in milligrams at 240 minutes
Measured: At 240 minutes after arriving in Post Anesthesia care Unit
Secondary outcomes (5)
Pain Score on a Scale of 1-10 (1=Least 10= Worst)
Pain scores on a scale of 1-10 measured in the post anesthesia care unit at 240 minutes
Measured: At 240 minutes after arriving in Post Anesthesia care Unit
Heart Rate - Per Minute
Heart Rate as recorded in the Medical record at 240 Minutes
Measured: At 240 minutes after arriving in Post Anesthesia care Unit
Blood Pressure - Measured in mmHg
Blood Pressure as recorded in the Medical record at 240 Minutes
Measured: At 240 minutes after arriving in Post Anesthesia care Unit
Oxygen Saturation - Measured in Percentage
Oxygen Saturation as recorded in the medical record at 240 minutes
Measured: At 240 minutes after arriving in Post Anesthesia care Unit
Respiratory Rate as Measured Per Minute
Breaths per minute as recorded in the medical record at 240 minutes
Measured: At 240 minutes after arriving in Post Anesthesia care Unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startAug 2014
- Primary completion25 Jun 2018
- Study completion25 Jun 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by West Virginia 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pavithra Ellison, West Virginia University
- Investigators
- Pavithra Ranganathan, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604940
- Sponsor's protocol ID
- 1306055796
- Status last verified
- Dec 2023
- First submitted
- 14 Oct 2015
- Last updated
- 17 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ranganathan P, Ritchie MK, Ellison MB, Petrone A, Heiraty P, Tabone LE. A randomized control trial using intraoperative dexmedetomidine during Roux-en-Y gastric bypass surgery to reduce postoperative pain and narcotic use. Surg Obes Relat Dis. 2019 Apr;15(4):588-594. doi: 10.1016/j.soard.2019.01.021. Epub 2019 Jan 31.
PubMed 30824336
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Single Intra-operative Dose of Dexmedetomidine on Post-operative Narcotic Requirements and Pain Scores in Bariatric Surgery Patients
- ClinicalTrials.gov ID
- NCT02604940
- Acronym / sponsor ID
- 1306055796
- Conditions
- Pain
- Keywords
- Postoperative narcotic requirements, Dexmedetomidine, Bariatric Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 16 Nov 2015 (estimated)
- Results
- Posted 17 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether a single bolus dose of dexmedetomidine administered during bariatric surgery has any effect on the amount of narcotic pain medications required by an individual after surgery. Patients who undergo weight loss surgery will be randomized into two groups - group one -dexmedetomidine group and group two- control group. Both groups will receive a standard anesthetic. Control group will receive weight based dose of fentanyl (standard narcotic pain reliever), intravenous acetaminophen (non-narcotic pain reliever), and 60ml saline. Experimental group will receive weight based dose of fentanyl (standard narcotic pain reliever), intravenous acetaminophen (non-narcotic pain reliever), and dexmedetomidine (given as 1mcg/kg over 10 minutes Intravenous). The Patient will then awaken after surgery in post anesthetic recovery unit and be given a patient controlled analgesia (PCA) pump with hydromorphone (long acting narcotic pain reliever). The amount of hydromorphone used will be recorded by the PACU nurse to the electronic health record ( routine practice) in the two groups and compared for pain medicine requirements. Secondary endpoints will be Visual Analog Score (VAS) pain score, respiratory rate, heart rate, blood pressure oxygen saturation and respiratory rate. All will be recorded at 30,60,90,120 and 240 minutes in the electronic medical record in PACU and compared between the two groups . All the data - Intra operative and Post -operative - Post Anesthesia Care Unit ( PACU) data will be retrieved from the electronic Medical record (EMR). All intra-operative data is automatically computed into the patients EMR. All PACU data is routinely entered into the EMR by the PACU nurse including the PCA data.
Detailed description
This study will evaluate the postoperative opioid sparing effects of dexmedetomidine given as single bolus dose intraoperatively. Dexmedetomidine is an agonist of α2-adrenergic receptors sedative medication used by intensive care units and anesthesiologists and is unique in its ability to provide sedation without causing respiratory depression. Recently, it has received attention for its potential for additive analgesia. The study population will be patients undergoing gastric bypass surgery. The study population of bariatric surgery patients was chosen due to high prevalence of sleep apnea and Pickwickian component that can be worsened with opioid analgesia in the postoperative period. The purpose of the study is to test whether the use of a single bolus dose dexmedetomidine in addition to standard dose pain regimen decreases postoperative narcotic requirements when compared to standard dose pain regimen alone. The secondary purpose is to study whether single bolus dose dexmedetomidine reduces respiratory rate, heart rate, systolic and mean blood pressure, patient PCA demand bolus requests and VAS pain scores in the postoperative period. The overall goal of the study is to establish evidence of dexmedetomidine's role in multimodal pain relief in the bariatric surgery population with the possibility of other patient subgroups to follow
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Experimental | Drug: DexmedetomidineExperimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure |
| Normal Saline | Active comparator | Drug: Normal SalineControl group will receive Normal saline over 15 minutes at the beginning of surgical closure |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients must be undergoing open bariatric surgery at WVUH-ruby hospital. - They must be ASA class 1, 2 and 3.
- Consented individuals.
- They must be between the age of 18 to 55.
Key exclusion criteria (7 listed)
- History of bradycardia or tachy-brady syndrome HR<45.
- 1st degree heart block or higher.
- Patient refusal.
- On pain medication for any reason for more than 24 hrs within 2 weeks of procedure.
- Allergy to medication.
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 |
|---|---|---|
| DexmedetomidineAlso: Precedex1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure | Drug | dexmedetomidine |
| Normal Saline60ml Saline delivered over 10 minutes in OR upon notification of surgical closure. | Drug | Normal Saline |
Primary outcome
Quantity of Narcotic Utilized by Patient for Pain in Milligrams at 240 Minutes
Time frame: At 240 minutes after arriving in Post Anesthesia care Unit
Amount of narcotic delivered to patient by Patient Controlled Analgesia (PCA)Pump in milligrams at 240 minutes
5 secondary outcomes
Pain Score on a Scale of 1-10 (1=Least 10= Worst)
Time frame: At 240 minutes after arriving in Post Anesthesia care Unit
Heart Rate - Per Minute
Time frame: At 240 minutes after arriving in Post Anesthesia care Unit
Blood Pressure - Measured in mmHg
Time frame: At 240 minutes after arriving in Post Anesthesia care Unit
Oxygen Saturation - Measured in Percentage
Time frame: At 240 minutes after arriving in Post Anesthesia care Unit
Respiratory Rate as Measured Per Minute
Time frame: At 240 minutes after arriving in Post Anesthesia care Unit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30824336Ranganathan P, Ritchie MK, Ellison MB, Petrone A, Heiraty P, Tabone LE. A randomized control trial using intraoperative dexmedetomidine during Roux-en-Y gastric bypass surgery to reduce postoperative pain and narcotic use. Surg Obes Relat Dis. 2019 Apr;15(4):588-594. doi: 10.1016/j.soard.2019.01.021. Epub 2019 Jan 31.
- 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.
Pavithra Ranganathan principal investigator
West Virginia University
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 Dexmedetomidine and Normal Saline in people with Pain, run by West Virginia University 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 3 inclusion and 7 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 17 Jan 2024. 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.
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?
Yes. Results are posted in the registry (first posted 17 Jan 2024). 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?
Quantity of Narcotic Utilized by Patient for Pain in Milligrams at 240 Minutes (time frame: At 240 minutes after arriving in Post Anesthesia care Unit). 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 NCT02604940, 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 17 Jan 2024.