WVU Healthcare Ruby Memorial Hospital
Morgantown, West Virginia, 26506, United States
NCT Number: NCT02604940
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.
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 4
Morgantown, West Virginia, 26506, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure
Other names: Precedex
60ml Saline delivered over 10 minutes in OR upon notification of surgical closure.
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
Time frame: At 240 minutes after arriving in Post Anesthesia care Unit
Pain scores on a scale of 1-10 measured in the post anesthesia care unit at 240 minutes
Time frame: At 240 minutes after arriving in Post Anesthesia care Unit
Heart Rate as recorded in the Medical record at 240 Minutes
Time frame: At 240 minutes after arriving in Post Anesthesia care Unit
Blood Pressure as recorded in the Medical record at 240 Minutes
Time frame: At 240 minutes after arriving in Post Anesthesia care Unit
Oxygen Saturation as recorded in the medical record at 240 minutes
Time frame: At 240 minutes after arriving in Post Anesthesia care Unit
Breaths per minute as recorded in the medical record at 240 minutes
West Virginia University
Other
Evaluation of a Single Intra-operative Dose of Dexmedetomidine on Post-operative Narcotic Requirements and Pain Scores in Bariatric Surgery Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07025161
Neurologic Manifestations, Pain
Orlando, Florida, United States
View Trial DetailsNCT05283980
Acute Pain, Behavior
Boston, Massachusetts, United States
View Trial DetailsNCT06869369
Behavior, Motor Activity
Kütahya, Turkey (Türkiye)
View Trial DetailsNCT07729020
Anxiety, Anxiety Disorders
Genoa, Liguria, Italy
View Trial Details