Trial Outcomes & Findings for Effect of Opioid Free Anesthetic on Post-Operative Opioid Consumption After Laparoscopic Bariatric Surgery (NCT NCT04081545)

NCT ID: NCT04081545

Last Updated: 2024-11-20

Results Overview

Total amount of opioid use within the first 24 hours after surgery in mg of oral morphine equivalent doses

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 181 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2024-11-20

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	86	95
Overall Study COMPLETED	86	95
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Control Goup A- Opioid-based Regimen n=86 Participants 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	Experimental Group B- Opioid-free Regimen n=95 Participants 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	Total n=181 Participants Total of all reporting groups
Age, Continuous	46.4 years STANDARD_DEVIATION 11.6 • n=86 Participants	46.3 years STANDARD_DEVIATION 13.1 • n=95 Participants	46.3 years STANDARD_DEVIATION 12.3 • n=181 Participants
Sex: Female, Male Female	70 Participants n=86 Participants	74 Participants n=95 Participants	144 Participants n=181 Participants
Sex: Female, Male Male	16 Participants n=86 Participants	21 Participants n=95 Participants	37 Participants n=181 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Weight	124 kilograms n=86 Participants	122 kilograms n=95 Participants	123 kilograms n=181 Participants
Ideal Body Weight (IBW)	59 kilograms n=86 Participants	60 kilograms n=95 Participants	60 kilograms n=181 Participants
Body Mass Index	44 kilograms/meter^2 n=86 Participants	43 kilograms/meter^2 n=95 Participants	43 kilograms/meter^2 n=181 Participants
American Society of Anesthesiologists (ASA) class 2	30 Participants n=86 Participants	16 Participants n=95 Participants	46 Participants n=181 Participants
American Society of Anesthesiologists (ASA) class 3	56 Participants n=86 Participants	79 Participants n=95 Participants	135 Participants n=181 Participants

PRIMARY outcome

Timeframe: 24 hours

Total amount of opioid use within the first 24 hours after surgery in mg of oral morphine equivalent doses

Outcome measures

Measure	Control Goup A- Opioid-based Regimen n=86 Participants 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	Experimental Group B- Opioid-free Regimen n=95 Participants 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
24 Hour Opioid Consumption Including PACU	51 mg oral morphine equivalents (OMEs) Standard Deviation 34	55 mg oral morphine equivalents (OMEs) Standard Deviation 31
24 Hour Opioid Consumption Excluding PACU	27 mg oral morphine equivalents (OMEs) Standard Deviation 24	32 mg oral morphine equivalents (OMEs) Standard Deviation 23

SECONDARY outcome

Timeframe: 1-5 hours

Time from induction to emergence of anesthesia

Outcome measures

Measure	Control Goup A- Opioid-based Regimen n=86 Participants 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	Experimental Group B- Opioid-free Regimen n=95 Participants 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
Length of Time Under General Anesthesia	3.47 hours Standard Deviation 1.02	3.32 hours Standard Deviation 1.04

SECONDARY outcome

Timeframe: 24 hours

Population: Some subjective, patient-reported data collection failed; these participants were excluded from this outcome

Adverse effects include postoperative nausea, vomiting, pruritis, and respiratory depression. Some subjective, patient-reported data collection failed; these participants were excluded from this outcome.

Outcome measures

Measure	Control Goup A- Opioid-based Regimen n=86 Participants 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	Experimental Group B- Opioid-free Regimen n=95 Participants 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
Percentage of Patients With Opioid-related Adverse Effects Experienced vomiting	19 Participants	16 Participants
Percentage of Patients With Opioid-related Adverse Effects Experienced pruritis	2 Participants	4 Participants
Percentage of Patients With Opioid-related Adverse Effects Oxygen requirement beyond postanesthesia care unit	21 Participants	29 Participants

SECONDARY outcome

Timeframe: 1-3 hours

Time from arrival to PACU to "ready for PACU discharge"

Outcome measures

Measure	Control Goup A- Opioid-based Regimen n=86 Participants 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	Experimental Group B- Opioid-free Regimen n=95 Participants 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
Length of Time to Recover From General Anesthesia	1.33 hours Standard Deviation 0.62	1.41 hours Standard Deviation 0.75

SECONDARY outcome

Timeframe: 1-5 days

Time from PACU arrival to discharge date and time in days

Outcome measures

Measure	Control Goup A- Opioid-based Regimen n=86 Participants 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	Experimental Group B- Opioid-free Regimen n=95 Participants 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
Length of Hospital Stay	1.45 days Standard Deviation 0.6	1.58 days Standard Deviation 0.76

SECONDARY outcome

Timeframe: 24 hours

Population: Some subjective, patient-reported data collection failed; these participants were excluded from this outcome

Number of Participants With Overall Patient Satisfaction With Analgesia

Outcome measures

Measure	Control Goup A- Opioid-based Regimen n=80 Participants 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	Experimental Group B- Opioid-free Regimen n=87 Participants 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
Overall Patient Satisfaction With Analgesia: Yes or no	73 Participants	72 Participants

SECONDARY outcome

Timeframe: 30 days

Number of participates with opioid prescription refills since surgery within 30 day after surgery

Outcome measures

Measure	Control Goup A- Opioid-based Regimen n=86 Participants 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	Experimental Group B- Opioid-free Regimen n=95 Participants 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
Number of Participants With Post-surgical Opioid Prescription Refills up to 30 Days	9 Participants	10 Participants

SECONDARY outcome

Timeframe: Intraoperative, between time entering OR and PACU arrival time

Population: Lowest intra-op heart rate less than 50 beats per minute

Episodes of severe bradycardia or treated hypotension intraoperatively

Outcome measures

Measure	Control Goup A- Opioid-based Regimen n=86 Participants 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	Experimental Group B- Opioid-free Regimen n=95 Participants 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
Percentage of Patients Treated for General Anesthetic Adverse Effects Severe bradycardia intraoperatively (lowest HR <50 bpm)	10 Participants	17 Participants
Percentage of Patients Treated for General Anesthetic Adverse Effects Received phenylephrine intraoperatively	41 Participants	67 Participants
Percentage of Patients Treated for General Anesthetic Adverse Effects Received ephedrine intraoperatively	28 Participants	54 Participants

SECONDARY outcome

Timeframe: 3 months

Number of participates with opioid prescription refills since surgery between 30 day and 3 months after surgery

Outcome measures

Measure	Control Goup A- Opioid-based Regimen n=86 Participants 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	Experimental Group B- Opioid-free Regimen n=95 Participants 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
Number of Participants With Post-surgical Opioid Prescription Refills Between 30 Days to 3 Months After Surgery	8 Participants	4 Participants

Adverse Events

Control Goup A- Opioid-based Regimen

Serious events: 0 serious events

Other events: 51 other events

Deaths: 0 deaths

Experimental Group B- Opioid-free Regimen

Serious events: 0 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Control Goup A- Opioid-based Regimen n=86 participants at risk 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	Experimental Group B- Opioid-free Regimen n=95 participants at risk 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
Respiratory, thoracic and mediastinal disorders Oxygen requirement beyond postanesthesia care unit	26.2% 21/80 • Number of events 21 • 3 months Some subjective, patient-reported data collection failed; these participants were excluded from these outcome.	33.3% 29/87 • Number of events 29 • 3 months Some subjective, patient-reported data collection failed; these participants were excluded from these outcome.
Gastrointestinal disorders Experienced vomiting	23.8% 19/80 • Number of events 19 • 3 months Some subjective, patient-reported data collection failed; these participants were excluded from these outcome.	18.6% 16/86 • Number of events 16 • 3 months Some subjective, patient-reported data collection failed; these participants were excluded from these outcome.
Skin and subcutaneous tissue disorders Experienced pruritis	2.5% 2/80 • Number of events 2 • 3 months Some subjective, patient-reported data collection failed; these participants were excluded from these outcome.	4.7% 4/86 • Number of events 4 • 3 months Some subjective, patient-reported data collection failed; these participants were excluded from these outcome.
Cardiac disorders Severe bradycardia	11.6% 10/86 • Number of events 10 • 3 months Some subjective, patient-reported data collection failed; these participants were excluded from these outcome.	17.9% 17/95 • Number of events 17 • 3 months Some subjective, patient-reported data collection failed; these participants were excluded from these outcome.
Nervous system disorders Experienced sedation beyond postanesthesia care unit	31.2% 25/80 • Number of events 25 • 3 months Some subjective, patient-reported data collection failed; these participants were excluded from these outcome.	24.1% 21/87 • Number of events 21 • 3 months Some subjective, patient-reported data collection failed; these participants were excluded from these outcome.

Additional Information

Christine Oryhan

Virginia Mason Medical Center

Phone: 206-223-6980

Email: christine.oryhan@virginiamason.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place