Evaluation of Dexmedetomidine on Post-operative Narcotic Requirements and Pain Scores in Bariatric Patients

Study Overview
=================
Brief 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.

Detailed Description
-----------------
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

Official Title
-----------------
Evaluation of a Single Intra-operative Dose of Dexmedetomidine on Post-operative Narcotic Requirements and Pain Scores in Bariatric Surgery Patients

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Normal Saline


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine<br>Experimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure | Drug: Dexmedetomidine<br>* 1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure<br>* Other names: Precedex;|
| Active Comparator: Normal Saline<br>Control group will receive Normal saline over 15 minutes at the beginning of surgical closure | Drug: Normal Saline<br>* 60ml Saline delivered over 10 minutes in OR upon notification of surgical closure.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 30 minutes | At 30 minutes | 
| 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 60 minutes | At 60 minutes | 
| 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 90 minutes | At 90 minutes | 
| 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 120 minutes | At 120 minutes | 
| 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 | 
| Heart Rate - Per Minute | Heart Rate as recorded in the Medical record at 30 Minutes | At 30 minutes | 
| Heart Rate - Per Minute | Heart Rate as recorded in the Medical record at 60 Minutes | At 60 minutes | 
| Heart Rate - per Minute | Heart Rate as recorded in the Medical record at 90 Minutes | At 90 minutes | 
| Heart Rate - Per minute | Heart Rate as recorded in the Medical record at 120 Minutes | At 120 minutes | 
| Heart Rate - Per minute | Heart Rate as recorded in the Medical record at 240 Minutes | At 240 minutes | 
| Blood Pressure - measured in mmHg | Blood Pressure as recorded in the Medical record at 30 Minutes | At 30 minutes | 
| Blood Pressure - measured in mmHg | Blood Pressure as recorded in the Medical record at 60 Minutes | At 60 minutes | 
| Blood Pressure - measured in mmHg | Blood Pressure as recorded in the Medical record at 90 Minutes | At 90 minutes | 
| Blood Pressure - measured in mmHg | Blood Pressure as recorded in the Medical record at 120 Minutes | At 120 minutes | 
| Blood Pressure - measured in mmHg | Blood Pressure as recorded in the Medical record at 240 Minutes | At 240 minutes | 
| Oxygen Saturation - measured in percentage | Oxygen Saturation as recorded in the medical record at 30 minutes | At 30 minutes | 
| Oxygen Saturation - measured in percentage | Oxygen Saturation as recorded in the medical record at 60 minutes | At 60 minutes | 
| Oxygen Saturation - measured in percentage | Oxygen Saturation as recorded in the medical record at 90 minutes | At 90 minutes | 
| Oxygen Saturation - measured in percentage | Oxygen Saturation as recorded in the medical record at 120 minutes | At 120 minutes | 
| Oxygen Saturation - measured in percentage | Oxygen Saturation as recorded in the medical record at 240 minutes | At 240 minutes | 
| Respiratory Rate as measured per minute | Respiratory rate measured per minute as recorded in the medical record at 30 minutes | At 30 mins | 
| Respiratory Rate as measured per minute | Respiratory rate measured per minute as recorded in the medical record at 60 minutes | At 60 mins | 
| Respiratory Rate as measured per minute | Respiratory rate measured per minute as recorded in the medical record at 90 minutes | At 90 mins | 
| Respiratory Rate as measured per minute | Respiratory rate measured per minute as recorded in the medical record at 120 minutes | At 120 mins | 
| Respiratory Rate as measured per minute | Respiratory rate measured per minute as recorded in the medical record at 240 minutes | At 240 mins | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative narcotic requirements, Dexmedetomidine, Bariatric Surgery