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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexmedetomidine | Experimental | Experimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure |
|
| Normal Saline | Active Comparator | Control group will receive Normal saline over 15 minutes at the beginning of surgical closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 240 minutes after arriving in Post Anesthesia care Unit |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 240 minutes after arriving in Post Anesthesia care Unit |
| Heart Rate - Per Minute |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pavithra Ranganathan | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WVU Healthcare Ruby Memorial Hospital | Morgantown | West Virginia | 26506 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30824336 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine | Experimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure Dexmedetomidine: 1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure |
| FG001 | Normal Saline | Control group will receive Normal saline over 15 minutes at the beginning of surgical closure Normal Saline: 60ml Saline delivered over 10 minutes in OR upon notification of surgical closure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine | Experimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure Dexmedetomidine: 1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure |
| BG001 | Normal Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | mg | At 240 minutes after arriving in Post Anesthesia care Unit |
|
Collected over 4 hours during PACU recovery
PACU Standard of Care procedures
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexmedetomidine | Experimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure Dexmedetomidine: 1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pavithra Ranganathan Ellison, MD | West Virginia University | 304-598-4929 | pavithra.ellison@wvumedicine.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 9, 2014 | May 19, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 16, 2015 | Aug 31, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Normal Saline | Drug | 60ml Saline delivered over 10 minutes in OR upon notification of surgical closure. |
|
Heart Rate as recorded in the Medical record at 240 Minutes
| 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 | 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 | 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 | At 240 minutes after arriving in Post Anesthesia care Unit |
Control group will receive Normal saline over 15 minutes at the beginning of surgical closure Normal Saline: 60ml Saline delivered over 10 minutes in OR upon notification of surgical closure. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index | Mean | Full Range | kg/m^2 |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | At 240 minutes after arriving in Post Anesthesia care Unit |
|
|
|
| Secondary | Heart Rate - Per Minute | Heart Rate as recorded in the Medical record at 240 Minutes | Posted | Mean | Standard Deviation | beats per minute | At 240 minutes after arriving in Post Anesthesia care Unit |
|
|
|
| Secondary | Blood Pressure - Measured in mmHg | Blood Pressure as recorded in the Medical record at 240 Minutes | Posted | Mean | Standard Deviation | mmHg | At 240 minutes after arriving in Post Anesthesia care Unit |
|
|
|
| Secondary | Oxygen Saturation - Measured in Percentage | Oxygen Saturation as recorded in the medical record at 240 minutes | Posted | Mean | Standard Deviation | percentage of oxygen saturation | At 240 minutes after arriving in Post Anesthesia care Unit |
|
|
|
| Secondary | Respiratory Rate as Measured Per Minute | Breaths per minute as recorded in the medical record at 240 minutes | Posted | Mean | Standard Deviation | Breaths per minute | At 240 minutes after arriving in Post Anesthesia care Unit |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Normal Saline | Control group will receive Normal saline over 15 minutes at the beginning of surgical closure Normal Saline: 60ml Saline delivered over 10 minutes in OR upon notification of surgical closure. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |