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

NCT02604940 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 1306055796
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Postoperative narcotic requirements; Dexmedetomidine; Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pain Score on a Scale of 1-10 (1=Least 10= Worst)

  At 240 minutes after arriving in Post Anesthesia care Unit

• Heart Rate - Per Minute

  At 240 minutes after arriving in Post Anesthesia care Unit

• Blood Pressure - Measured in mmHg

  At 240 minutes after arriving in Post Anesthesia care Unit

• Oxygen Saturation - Measured in Percentage

  At 240 minutes after arriving in Post Anesthesia care Unit

• Respiratory Rate as Measured Per Minute

  At 240 minutes after arriving in Post Anesthesia care Unit

Study Arms (2)

dexmedetomidine

EXPERIMENTAL

Experimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure

Drug: Dexmedetomidine

Normal Saline

ACTIVE COMPARATOR

Control group will receive Normal saline over 15 minutes at the beginning of surgical closure

Drug: Normal Saline

Interventions

Dexmedetomidine DRUG

1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure

Also known as: Precedex

dexmedetomidine

Normal Saline DRUG

60ml Saline delivered over 10 minutes in OR upon notification of surgical closure.

Normal Saline

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• History of bradycardia or tachy-brady syndrome HR\<45.
• st 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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

WVU Healthcare Ruby Memorial Hospital

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

• 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.

  PMID: 30824336 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Pavithra Ranganathan Ellison, MD
• Organization: West Virginia University

pavithra.ellison@wvumedicine.org

304-598-4929

Study Officials

• Pavithra Ranganathan

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of anesthesiology

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: November 16, 2015
• Study Start: August 1, 2014
• Primary Completion: June 25, 2018
• Study Completion: June 25, 2018
• Last Updated: January 17, 2024
• Results First Posted: January 17, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)