Phase 4
N=46
Evaluation of Dexmedetomidine on Post-operative Narcotic Requirements and Pain Scores in Bariatric Patients
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02604940 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Quantity of Narcotic Utilized by Patient for Pain in Milligrams at 240 Minutes — 2.66; 3.7 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexmedetomidine (Drug); Normal Saline (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- West Virginia University
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quantity of Narcotic Utilized by Patient for Pain in Milligrams at 240 Minutes |
2.66; 3.7 | — |
| SECONDARY Pain Score on a Scale of 1-10 (1=Least 10= Worst) |
3.6; 6.7 | — |
| SECONDARY Heart Rate - Per Minute |
70; 86 | — |
| SECONDARY Blood Pressure - Measured in mmHg |
107; 148; 56; 79 | — |
| SECONDARY Oxygen Saturation - Measured in Percentage |
97; 99 | — |
| SECONDARY Respiratory Rate as Measured Per Minute |
17; 17 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02604940). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.