Skip to content

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02604940
Enrollment
46
Registered
2015-11-16
Start date
2014-08-31
Completion date
2018-06-25
Last updated
2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Postoperative narcotic requirements, Dexmedetomidine, Bariatric Surgery

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

Interventions

DRUGDexmedetomidine

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

DRUGNormal Saline

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

Sponsors

West Virginia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quantity of Narcotic Utilized by Patient for Pain in Milligrams at 240 MinutesAt 240 minutes after arriving in Post Anesthesia care UnitAmount of narcotic delivered to patient by Patient Controlled Analgesia (PCA)Pump in milligrams at 240 minutes

Secondary

MeasureTime frameDescription
Pain Score on a Scale of 1-10 (1=Least 10= Worst)At 240 minutes after arriving in Post Anesthesia care UnitPain scores on a scale of 1-10 measured in the post anesthesia care unit at 240 minutes
Heart Rate - Per MinuteAt 240 minutes after arriving in Post Anesthesia care UnitHeart Rate as recorded in the Medical record at 240 Minutes
Blood Pressure - Measured in mmHgAt 240 minutes after arriving in Post Anesthesia care UnitBlood Pressure as recorded in the Medical record at 240 Minutes
Oxygen Saturation - Measured in PercentageAt 240 minutes after arriving in Post Anesthesia care UnitOxygen Saturation as recorded in the medical record at 240 minutes
Respiratory Rate as Measured Per MinuteAt 240 minutes after arriving in Post Anesthesia care UnitBreaths per minute as recorded in the medical record at 240 minutes

Countries

United States

Participant flow

Participants by arm

ArmCount
Dexmedetomidine
Experimental group will receive 1mcg/kg IV dexmedetomidine over 10 minutes intraoperatively at the beginning of surgical closure Dexmedetomidine: 1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure
26
Normal Saline
Control group will receive Normal saline over 15 minutes at the beginning of surgical closure Normal Saline: 60ml Saline delivered over 10 minutes in OR upon notification of surgical closure.
20
Total46

Baseline characteristics

CharacteristicDexmedetomidineNormal SalineTotal
Age, Continuous45.1 years43.2 years44.3 years
Body Mass Index46.0 kg/m^245.63 kg/m^245.89 kg/m^2
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
21 Participants16 Participants37 Participants
Sex: Female, Male
Male
5 Participants4 Participants9 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 260 / 20
other
Total, other adverse events
0 / 260 / 20
serious
Total, serious adverse events
0 / 260 / 20

Outcome results

Primary

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

Time frame: At 240 minutes after arriving in Post Anesthesia care Unit

ArmMeasureValue (MEAN)Dispersion
DexmedetomidineQuantity of Narcotic Utilized by Patient for Pain in Milligrams at 240 Minutes2.66 mgStandard Deviation 2.02
Normal SalineQuantity of Narcotic Utilized by Patient for Pain in Milligrams at 240 Minutes3.7 mgStandard Deviation 2.3
Secondary

Blood Pressure - Measured in mmHg

Blood Pressure as recorded in the Medical record at 240 Minutes

Time frame: At 240 minutes after arriving in Post Anesthesia care Unit

ArmMeasureGroupValue (MEAN)Dispersion
DexmedetomidineBlood Pressure - Measured in mmHgSystolic BP107 mmHgStandard Deviation 17
DexmedetomidineBlood Pressure - Measured in mmHgDiastolic BP56 mmHgStandard Deviation 15
Normal SalineBlood Pressure - Measured in mmHgSystolic BP148 mmHgStandard Deviation 16
Normal SalineBlood Pressure - Measured in mmHgDiastolic BP79 mmHgStandard Deviation 13
Secondary

Heart Rate - Per Minute

Heart Rate as recorded in the Medical record at 240 Minutes

Time frame: At 240 minutes after arriving in Post Anesthesia care Unit

ArmMeasureValue (MEAN)Dispersion
DexmedetomidineHeart Rate - Per Minute70 beats per minuteStandard Deviation 12
Normal SalineHeart Rate - Per Minute86 beats per minuteStandard Deviation 14
Secondary

Oxygen Saturation - Measured in Percentage

Oxygen Saturation as recorded in the medical record at 240 minutes

Time frame: At 240 minutes after arriving in Post Anesthesia care Unit

ArmMeasureValue (MEAN)Dispersion
DexmedetomidineOxygen Saturation - Measured in Percentage97 percentage of oxygen saturationStandard Deviation 2
Normal SalineOxygen Saturation - Measured in Percentage99 percentage of oxygen saturationStandard Deviation 2
Secondary

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

Time frame: At 240 minutes after arriving in Post Anesthesia care Unit

ArmMeasureValue (MEAN)Dispersion
DexmedetomidinePain Score on a Scale of 1-10 (1=Least 10= Worst)3.6 score on a scaleStandard Deviation 2.8
Normal SalinePain Score on a Scale of 1-10 (1=Least 10= Worst)6.7 score on a scaleStandard Deviation 3
Secondary

Respiratory Rate as Measured Per Minute

Breaths per minute as recorded in the medical record at 240 minutes

Time frame: At 240 minutes after arriving in Post Anesthesia care Unit

ArmMeasureValue (MEAN)Dispersion
DexmedetomidineRespiratory Rate as Measured Per Minute17 Breaths per minuteStandard Deviation 4
Normal SalineRespiratory Rate as Measured Per Minute17 Breaths per minuteStandard Deviation 3

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026