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NCT02604940 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Dexmedetomidine on Post-operative Narcotic Requirements and Pain Scores in Bariatric Patients
A Phase 4 study of Pain, sponsored by West Virginia University.
- Completed
- Registry status
- Phase 4
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT02604940: Completed Phase 4 study of Pain, sponsored by West Virginia University.
NCT02604940 is a Phase 4 study of Pain that has completed, run by West Virginia University. The registered enrollment target is 46 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02604940, a Phase 4 study of Pain, has completed, sponsored by West Virginia University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Conditions Studied
Interventions
- DRUG Dexmedetomidine
- DRUG Normal Saline
Study Locations (1)
West Virginia
- WVU Healthcare Ruby Memorial Hospital - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2014-08 |
| Est. Completion | 2018-06-25 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02604940
The ClinicalTrials.gov registry entry for NCT02604940 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (85% lower). The listed sponsor is West Virginia University, which has 122 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Dexmedetomidine is the first listed.
NCT02604940 reports 1 study location spanning 1 distinct geographic area - top geographies include West Virginia.
Frequently Asked Questions
What is clinical trial NCT02604940 about?
NCT02604940 is a clinical study titled "Evaluation of Dexmedetomidine on Post-operative Narcotic Requirements and Pain Scores in Bariatric 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...
What is the current status of trial NCT02604940?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 46 participants. The study started on 2014-08. Estimated completion is 2018-06-25.
What conditions does trial NCT02604940 study?
This clinical trial studies the following conditions: Pain.
What interventions are being tested in trial NCT02604940?
The interventions under investigation include: Dexmedetomidine (DRUG), Normal Saline (DRUG).
Who is sponsoring clinical trial NCT02604940?
This trial is sponsored by West Virginia University, which has 122 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02604940 being conducted?
This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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