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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Hospital Cost Differential

Hospital Length of stay

Incidence of post operative nausea and vomiting (PONV )

+7 more

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

NorthShore University HealthSystemLead Sponsor

132 Previous Clinical Trials

737,583 Total Patients Enrolled

Steven Greenberg, MDPrincipal InvestigatorNorthShore University HealthSystem

3 Previous Clinical Trials

319 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are septuagenarians able to participate in this experiment?

"In accordance with the accepted eligibility standards, those aged 18 to 90 are qualified for enrolment in this clinical trial."

Answered by AI

How many individuals have been incorporated into this research project thus far?

"Affirmative. Information hosted on clinicaltrials.gov confirms that this trial, which was initially published on November 7th 2023 is actively enrolling participants. Approximately 75 people need to be recruited from 1 medical center."

Answered by AI

Is this trial still recruiting participants?

"Affirmative. According to clinicaltrials.gov, this health research project is currently searching for volunteers. It was initially posted on November 7th 2023 and subsequently updated on the 1st of November in the same year. In total, 75 participants need to be recruited from a single site."

Answered by AI

Is it permissible for me to partake in this inquiry?

"This research study is recruiting 75 individuals aged 18-90 who are undergoing elective laparoscopic hiatal hernia repair. The primary inclusion criteria for this trial is the presence of a hiatal hernia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia

Steven Greenberg 2023. "Reducing Postoperative Opioids in Patients Undergoing Laparoscopic Hiatal Hernia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05953428.

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