Anesthesia Protocols for Hiatal Hernia Surgery

N/A

Recruiting

Led By Steven Greenberg, MD

Research Sponsored by NorthShore University HealthSystem

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during post anesthesia care unit stay (up to 3 hours), postoperative day 1, during hospital stay (up to 7 days)

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two anesthesia protocols to see if one reduces opioid use after surgery for hiatal hernia repair. Outcomes being studied include opioid use, pain, nausea/vomiting, readmissions, etc.

Who is the study for?

This trial is for adults aged 18-90 scheduled for elective laparoscopic hiatal hernia repair surgery. It's not suitable for those needing urgent or non-laparoscopic surgery, or with allergies to drugs used in the anesthesia protocols.

What is being tested?

The study compares two anesthesia methods during hiatal hernia surgery: an opioid sparing protocol (OSA) and a traditional opioid based one (OBA). The goal is to see if OSA reduces opioid use after surgery while maintaining pain control and satisfaction.

What are the potential side effects?

Potential side effects may include postoperative nausea and vomiting, varying levels of pain as measured by VAS scores, possible rehospitalization, emergency room visits, or need for reoperation. Surgeon satisfaction and hospital costs are also evaluated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during post anesthesia care unit stay (up to 3 hours), postoperative day 1, during hospital stay (up to 7 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during post anesthesia care unit stay (up to 3 hours), postoperative day 1, during hospital stay (up to 7 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during post anesthesia care unit stay (up to 3 hours), postoperative day 1, during hospital stay (up to 7 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The difference in discharge opioid consumption in morphine milligram equivalents (MMEs)

Secondary study objectives

Hospital Cost Differential

Hospital Length of stay

Incidence of post operative nausea and vomiting (PONV )

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Opioid Sparing Anesthesia ProtocolExperimental Treatment1 Intervention

The OSA protocol will include boluses of dexmedetomidine and ketamine at anesthesia induction, followed by a ketamine infusion that will continue until PACU discharge. Another bolus of ketamine will be administered upon surgical incision and another dexmedetomidine bolus will be given at surgical closure to reduce the use of opioids.

Group II: Opioid Based Anesthesia ProtocolExperimental Treatment1 Intervention

The OBA group will be administered a saline infusion at the same rate of the ketamine infusion (only while in the PACU) up until PACU discharge so that surgeons, patients, and PACU nurses will be blinded. The OBA group will be administered fentanyl 100 mcg IV for anesthesia induction followed by 50 mcg IV boluses when heart rate or systolic blood pressure is 20% above baseline throughout the case.

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