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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Normal Saline

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

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • WVU Healthcare Ruby Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

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 240 minutes	At 240 minutes after arriving in Post Anesthesia care Unit
Heart Rate - Per Minute	Heart Rate as recorded in the Medical record at 240 Minutes	At 240 minutes after arriving in Post Anesthesia care Unit
Blood Pressure - Measured in mmHg	Blood Pressure as recorded in the Medical record at 240 Minutes	At 240 minutes after arriving in Post Anesthesia care Unit
Oxygen Saturation - Measured in Percentage	Oxygen Saturation as recorded in the medical record at 240 minutes	At 240 minutes after arriving in Post Anesthesia care Unit
Respiratory Rate as Measured Per Minute	Breaths per minute as recorded in the medical record at 240 minutes	At 240 minutes after arriving in Post Anesthesia care Unit

Collaborators and Investigators

• Sponsor: West Virginia University
• Investigators: Principal Investigator: Pavithra Ranganathan, West Virginia University

Publications and helpful links

General Publications

• Ranganathan P, Ritchie MK, Ellison MB, Petrone A, Heiraty P, Tabone LE. A randomized control trial using intraoperative dexmedetomidine during Roux-en-Y gastric bypass surgery to reduce postoperative pain and narcotic use. Surg Obes Relat Dis. 2019 Apr;15(4):588-594. doi: 10.1016/j.soard.2019.01.021. Epub 2019 Jan 31.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): June 25, 2018
• Study Completion (Actual): June 25, 2018

Study Registration Dates

• First Submitted: October 14, 2015
• First Submitted That Met QC Criteria: November 11, 2015
• First Posted (Estimated): November 16, 2015

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Bariatric Surgery; Postoperative narcotic requirements
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 1306055796

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No