Evaluation of Dexmedetomidine on Post-operative Narcotic Requirements and Pain Scores in Bariatric Patients
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 8/18/2018 |
| Start Date: | August 2014 |
| End Date: | June 25, 2018 |
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.
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
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
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
We found this trial at
1
site
Morgantown, West Virginia 26506
Principal Investigator: Pavithra Ranganathan, M.B.,B.S.,
Phone: 304-598-4122
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