Opioid Use, Unspecified, Bariatric Surgery Candidate, Anesthesia
Conditions
Keywords
Opioid Free Anesthesia, Bariatric Surgery, Non-Opioid Anesthesia, Ketamine, Dexmedetomidine, Lidocaine
Brief summary
A comparison of post-operative opioid use in laparoscopic bariatric surgery patients receiving opioid or opioid-free anesthesia.
Detailed description
This is a prospective, single-center, single-blinded, randomized controlled trial comparing the effect of an opioid-free general anesthetic versus a traditional anesthetic with a restricted quantity of opioid on postoperative opioid consumption following laparoscopic bariatric surgery. The study population will be composed of 196 subjects undergoing laparoscopic bariatric surgery at Virginia Mason Medical center randomized into two groups. The control group will receive a traditional opioid restrictive general anesthetic. The study group will receive an opioid-free anesthetic technique.
Interventions
see arm/group description
see arm/group description
Sponsors
Virginia Mason Hospital/Medical Center
Christine Oryhan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
The investigators plan to enroll 196 subjects at Virginia Mason Medical Center that are undergoing laparoscopic bariatric surgery. Subjects who volunteer to be involved in the study will be randomized to either the opioid free or traditional anesthetic arm, with a computer generated arm assignment. Subjects will be blinded to the assigned arm. Group A will receive a traditional opioid restrictive general anesthetic and group B will receive an opioid-free anesthetic technique.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult patients undergoing elective laparoscopic bariatric surgery (i.e. laparoscopic roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy) able to provide informed consent
Exclusion criteria
* Any opioid use within 4 weeks prior to surgery * Chronic antiemetic use * Conversion of laparoscopic to open surgery * Patients unable to provide post-operative pain scores * Pregnant or lactating patients * Patients under 18 years of age * Refusal or inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24 Hour Opioid Consumption | 24 hours | Total amount of opioid use within the first 24 hours after surgery in mg of oral morphine equivalent doses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Opioid-related Adverse Effects | 24 hours | Adverse effects include postoperative nausea, vomiting, pruritis, and respiratory depression. Some subjective, patient-reported data collection failed; these participants were excluded from this outcome. |
| Length of Time to Recover From General Anesthesia | 1-3 hours | Time from arrival to PACU to ready for PACU discharge |
| Length of Hospital Stay | 1-5 days | Time from PACU arrival to discharge date and time in days |
| Length of Time Under General Anesthesia | 1-5 hours | Time from induction to emergence of anesthesia |
| Number of Participants With Post-surgical Opioid Prescription Refills up to 30 Days | 30 days | Number of participates with opioid prescription refills since surgery within 30 day after surgery |
| Percentage of Patients Treated for General Anesthetic Adverse Effects | Intraoperative, between time entering OR and PACU arrival time | Episodes of severe bradycardia or treated hypotension intraoperatively |
| Number of Participants With Post-surgical Opioid Prescription Refills Between 30 Days to 3 Months After Surgery | 3 months | Number of participates with opioid prescription refills since surgery between 30 day and 3 months after surgery |
| Overall Patient Satisfaction With Analgesia: Yes or no | 24 hours | Number of Participants With Overall Patient Satisfaction With Analgesia |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Goup A- Opioid-based Regimen Preop - Multimodals unless contraindicated
Induction
* Fentanyl (50mcg IV)
* Lidocaine 1.5mg/kg IV bolus using IBW (Ideal body weight)
* Propofol 2-3mg/kg IV bolus
* Neuromuscular blockade per Anesthesiology team discretion
Maintenance
* Sevoflurane
* Neuromuscular blockade at discretion of anesthesiology team
* May use fentanyl to treat SBP or HR \> 20% of baseline
Emergence
* Neuromuscular reversal, dosed according to Virginia Mason protocol
* May titrate fentanyl per anesthesiology team throughout the case.
* Patient extubated and brought to PACU
PACU opioid orders per anesthesiology team
Post-operative Nausea/Vomiting Prophylaxis
-4mg dexamethasone, 1mg haloperidol, scopolamine patch
Opioid Anesthetics: see arm/group description | 86 |
| Experimental Group B- Opioid-free Regimen Preop - Multimodals unless contraindicated
Induction
* Dexmedetomidine 1mcg/kg IV bolus over 10 minutes using IBW
* Lidocaine 1.5mg/kg IV bolus using IBW
* Propofol 2-3mg/kg IV bolus
* Neuromuscular blockade per Anesthesiology team discretion
* Ketamine 0.5mg/kg IV bolus (based on IBW)
Maintenance
* Sevoflurane
* Dexmedetomidine 0.4 mcg/kg/hr IV infusion using IBW (may titrate based on patient response between 0.3-0.5mcg/kg/hr)
* Lidocaine 2mg/kg/hr IV infusion using IBW
* May use esmolol as needed to treat SBP or HR \> 20% of baseline
* Neuromuscular blockade at the discretion of anesthesiology team
Emergence
* Dexmedetomidine infusion turned off during laparoscopic desufflation
* Lidocaine infusion turned off at skin closure
* Neuromuscular reversal, dosed according to VM protocol
* Pt extubated and brought to PACU
* PACU opioid orders per anesthesiology team
Post-operative Nausea/Vomiting Prophylaxis
-4mg dexamethasone, 1mg haloperidol, scopolamine patch
Non Opioid Analgesics: see arm/group description | 95 |
| Total | 181 |
Baseline characteristics
| Characteristic | Experimental Group B- Opioid-free Regimen | Total | Control Goup A- Opioid-based Regimen |
|---|---|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 13.1 | 46.3 years STANDARD_DEVIATION 12.3 | 46.4 years STANDARD_DEVIATION 11.6 |
| American Society of Anesthesiologists (ASA) class 2 | 16 Participants | 46 Participants | 30 Participants |
| American Society of Anesthesiologists (ASA) class 3 | 79 Participants | 135 Participants | 56 Participants |
| Body Mass Index | 43 kilograms/meter^2 | 43 kilograms/meter^2 | 44 kilograms/meter^2 |
| Ideal Body Weight (IBW) | 60 kilograms | 60 kilograms | 59 kilograms |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 74 Participants | 144 Participants | 70 Participants |
| Sex: Female, Male Male | 21 Participants | 37 Participants | 16 Participants |
| Weight | 122 kilograms | 123 kilograms | 124 kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 0 / 95 |
| other Total, other adverse events | 51 / 86 | 62 / 95 |
| serious Total, serious adverse events | 0 / 86 | 0 / 95 |
Outcome results
Primary
24 Hour Opioid Consumption
Total amount of opioid use within the first 24 hours after surgery in mg of oral morphine equivalent doses
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Goup A- Opioid-based Regimen | 24 Hour Opioid Consumption | Including PACU | 51 mg oral morphine equivalents (OMEs) | Standard Deviation 34 |
| Control Goup A- Opioid-based Regimen | 24 Hour Opioid Consumption | Excluding PACU | 27 mg oral morphine equivalents (OMEs) | Standard Deviation 24 |
| Experimental Group B- Opioid-free Regimen | 24 Hour Opioid Consumption | Including PACU | 55 mg oral morphine equivalents (OMEs) | Standard Deviation 31 |
| Experimental Group B- Opioid-free Regimen | 24 Hour Opioid Consumption | Excluding PACU | 32 mg oral morphine equivalents (OMEs) | Standard Deviation 23 |
Secondary
Length of Hospital Stay
Time from PACU arrival to discharge date and time in days
Time frame: 1-5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Goup A- Opioid-based Regimen | Length of Hospital Stay | 1.45 days | Standard Deviation 0.6 |
| Experimental Group B- Opioid-free Regimen | Length of Hospital Stay | 1.58 days | Standard Deviation 0.76 |
Secondary
Length of Time to Recover From General Anesthesia
Time from arrival to PACU to ready for PACU discharge
Time frame: 1-3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Goup A- Opioid-based Regimen | Length of Time to Recover From General Anesthesia | 1.33 hours | Standard Deviation 0.62 |
| Experimental Group B- Opioid-free Regimen | Length of Time to Recover From General Anesthesia | 1.41 hours | Standard Deviation 0.75 |
Secondary
Length of Time Under General Anesthesia
Time from induction to emergence of anesthesia
Time frame: 1-5 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Goup A- Opioid-based Regimen | Length of Time Under General Anesthesia | 3.47 hours | Standard Deviation 1.02 |
| Experimental Group B- Opioid-free Regimen | Length of Time Under General Anesthesia | 3.32 hours | Standard Deviation 1.04 |
Secondary
Number of Participants With Post-surgical Opioid Prescription Refills Between 30 Days to 3 Months After Surgery
Number of participates with opioid prescription refills since surgery between 30 day and 3 months after surgery
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Goup A- Opioid-based Regimen | Number of Participants With Post-surgical Opioid Prescription Refills Between 30 Days to 3 Months After Surgery | 8 Participants |
| Experimental Group B- Opioid-free Regimen | Number of Participants With Post-surgical Opioid Prescription Refills Between 30 Days to 3 Months After Surgery | 4 Participants |
Secondary
Number of Participants With Post-surgical Opioid Prescription Refills up to 30 Days
Number of participates with opioid prescription refills since surgery within 30 day after surgery
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Goup A- Opioid-based Regimen | Number of Participants With Post-surgical Opioid Prescription Refills up to 30 Days | 9 Participants |
| Experimental Group B- Opioid-free Regimen | Number of Participants With Post-surgical Opioid Prescription Refills up to 30 Days | 10 Participants |
Secondary
Overall Patient Satisfaction With Analgesia: Yes or no
Number of Participants With Overall Patient Satisfaction With Analgesia
Time frame: 24 hours
Population: Some subjective, patient-reported data collection failed; these participants were excluded from this outcome
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Goup A- Opioid-based Regimen | Overall Patient Satisfaction With Analgesia: Yes or no | 73 Participants |
| Experimental Group B- Opioid-free Regimen | Overall Patient Satisfaction With Analgesia: Yes or no | 72 Participants |
Secondary
Percentage of Patients Treated for General Anesthetic Adverse Effects
Episodes of severe bradycardia or treated hypotension intraoperatively
Time frame: Intraoperative, between time entering OR and PACU arrival time
Population: Lowest intra-op heart rate less than 50 beats per minute
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Goup A- Opioid-based Regimen | Percentage of Patients Treated for General Anesthetic Adverse Effects | Severe bradycardia intraoperatively (lowest HR <50 bpm) | 10 Participants |
| Control Goup A- Opioid-based Regimen | Percentage of Patients Treated for General Anesthetic Adverse Effects | Received phenylephrine intraoperatively | 41 Participants |
| Control Goup A- Opioid-based Regimen | Percentage of Patients Treated for General Anesthetic Adverse Effects | Received ephedrine intraoperatively | 28 Participants |
| Experimental Group B- Opioid-free Regimen | Percentage of Patients Treated for General Anesthetic Adverse Effects | Severe bradycardia intraoperatively (lowest HR <50 bpm) | 17 Participants |
| Experimental Group B- Opioid-free Regimen | Percentage of Patients Treated for General Anesthetic Adverse Effects | Received phenylephrine intraoperatively | 67 Participants |
| Experimental Group B- Opioid-free Regimen | Percentage of Patients Treated for General Anesthetic Adverse Effects | Received ephedrine intraoperatively | 54 Participants |
Secondary
Percentage of Patients With Opioid-related Adverse Effects
Adverse effects include postoperative nausea, vomiting, pruritis, and respiratory depression. Some subjective, patient-reported data collection failed; these participants were excluded from this outcome.
Time frame: 24 hours
Population: Some subjective, patient-reported data collection failed; these participants were excluded from this outcome
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Goup A- Opioid-based Regimen | Percentage of Patients With Opioid-related Adverse Effects | Experienced vomiting | 19 Participants |
| Control Goup A- Opioid-based Regimen | Percentage of Patients With Opioid-related Adverse Effects | Experienced pruritis | 2 Participants |
| Control Goup A- Opioid-based Regimen | Percentage of Patients With Opioid-related Adverse Effects | Oxygen requirement beyond postanesthesia care unit | 21 Participants |
| Experimental Group B- Opioid-free Regimen | Percentage of Patients With Opioid-related Adverse Effects | Oxygen requirement beyond postanesthesia care unit | 29 Participants |
| Experimental Group B- Opioid-free Regimen | Percentage of Patients With Opioid-related Adverse Effects | Experienced vomiting | 16 Participants |
| Experimental Group B- Opioid-free Regimen | Percentage of Patients With Opioid-related Adverse Effects | Experienced pruritis | 4 Participants |