Inhalational Anesthesia vs TIVA in Endoscopic Tympanoplasty (TIVA)

Comparison of Inhalational Anesthesia and Total Intravenous Anesthesia on Surgical Field Quality and Post-operative Recovery in Endoscopic Tympanoplasty

This study aims to prospectively compare surgical field quality and intraoperative blood loss between general inhalational anesthesia to total intravenous anesthesia (TIVA) alone in subjects undergoing endoscopic ear surgery. A secondary objective is to compare rates of emergence delirium and total recovery time between the two groups.

Study Overview

• Status: Recruiting
• Conditions: Perforated Eardrum
• Intervention / Treatment: Drug: Isoflurane Inhalant Product; Drug: Sevoflurane inhalant product; Drug: Propofol injection; Drug: Remifentanil Injection

Detailed Description

In sinus surgery, TIVA has been described as a possible advantage in the use of endoscopic ear surgery. However, to date, there are no studies that examine blood loss, surgical field quality, and recovery in TIVA compared to inhalational anesthesia in the setting of endoscopic ear surgery. The hypothesis is that in patients who undergo endoscopic tympanoplasty, those who receive TIVA will have reduced intraoperative blood loss, improved surgical field quality, and reduced emergence agitation than those who receive inhalational anesthesia. This study will be a prospective double-blinded randomized control trial consisting of subjects undergoing endoscopic tympanoplasty surgery to assess intraoperative blood loss, surgical field quality, rates of emergence delirium, and recovery time.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Leslie S Son, PhD; Phone Number: 225-765-7659; Email: Lson@lsuhsc.edu
• Study Contact Backup: Name: Christine LeBoeuf, DNP; Phone Number: 225-765-7659; Email: christine.leboeuf@fmolhs.org

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Recruiting
      • Our Lady of the Lake Hospital
      • Contact: Leslie Son, Ph.D.; Phone Number: 225-757-4165; Email: lson@lsuhsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individuals of all ages
• Scheduled to undergo an endoscopic tympanoplasty

Exclusion Criteria:

• Individuals with anticoagulation disorders
• Those receiving anticoagulation therapy currently

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Inhalational Anesthesia; Adults: The control group will receive general inhalational anesthesia (sevoflurane, isoflurane). The will be induced with fentanyl 1-2µg/kg, propofol 2mg/kg, lidocaine 1mg/kg. After orotracheal intubation, anesthesia will be maintained with isoflurane 1.5-2% or sevoflurane 1-2%. Children (12 or younger) induced with a combination of volatile anesthetic gases, including sevoflurane (up to 8%) and nitrous oxide gas (up to 70%). Those who are older than 12 will have an intravenous line placed in the preoperative area and as such will be induced with remifentanil and propofol as above. For maintenance, children in the control arm will receive 0.6 - 1.5% sevoflurane.	Drug: Isoflurane Inhalant Product; 1.5-2%; Drug: Sevoflurane inhalant product; 1-2% adults 0.6-1.5% Children
Active Comparator: Total Intravenous Anesthesia (TIVA); Adults: The comparator arm will receive total intravenous anesthesia (propofol and remifentanil). They will be induced with fentanyl 1-2µg/kg, propofol 2mg/kg, and lidocaine 1mg/kg. After orotracheal intubation, anesthesia will be maintained with propofol 100-200mcg/kg/min, remifentanil 0.05-2µg/kg/min. Children (12 or younger) induced with a combination of volatile anesthetic gases, including sevoflurane (up to 8%) and nitrous oxide gas (up to 70%). Those who are older than 12 will have an intravenous line placed in the preoperative area and as such will be induced with remifentanil and propofol as above. For maintenance, they will receive 100-200mcg/min propofol and 0.05-2µg/kg/min remifentanil.	Drug: Propofol injection; 1mg/kg-mcg/kg/min adults 100-200mcg/kg/min children; Drug: Remifentanil Injection; 0.05-2ug/kg/min adults and children

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Field Quality	Neurotologists will evaluate endoscopic video clips from each surgery to assess clarity of field at different points in the surgery using the Boezaart scale grading system. It is a scale from 0-5, with 0 being the most favorable outcome and 5 being the least favorable outcome.	Post-Operative evaluation (within 2 weeks)
Intra-operative blood loss	Intraoperative blood loss will be determined by measuring the total number of pledgets needed to attain hemostatsis. This will be a general observation with the more pledgets needed to stop bleeding in the surgical area indicates more possible blood loss than the procedures with that require less pledgets.	1-2 hours during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergent Delirium and Recovery Time-Riker Scale	Sedation and agitation will be assessed immediately after extubation using the Riker Sedation-Agitation Scale (SAS) which is on scale of 1-7 with 1 being the most favorable (easier to rouse/calm but responsive) and 7 being the least favorable (deeply sedated/higher agitation).	Immediately After extubation
Emergent Delirium and Recovery Time-Richmond Scale	Sedation and agitation will be assessed immediately after extubation using a second scale known as the Richmond Agitation-Sedation Scale (RASS). The RASS is on a scale of -5 to +4, with higher/more positive scores indicating worse outcomes (aka more aggressive behavior) and lower scores indicating better outcomes (less responsiveness). A score of 0(Zero) indicates a calm but alert patient.	Immediately After extubation
Post-operative pain or complications	Patients will recover for 1 hour in the post-anesthesia care unit, and a well-trained nurse blinded to the randomized study group will evaluate pain intensity by using the numeric rating scale (0-10 range, with higher scores indicating worse pain) at three intervals: immediately after arrival, 30 minutes after arrival, and 60 minutes after arrival. Any rescue analgesics that are administered will be documented. Patients will be observed postoperatively for any adverse events, as is standard procedure. Any other adverse features such as nausea, vomiting, or changes in vision or color will be followed for 30 days post procedure.	0-1 hour post-operative

Collaborators and Investigators

• Sponsor: Our Lady of the Lake Hospital
• Collaborators: Louisiana State University Health Sciences Center in New Orleans
• Investigators: Principal Investigator: Rahul Mehta, MD, Our Lady of the Lake Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: tympanoplasty; total intravenous anesthesia; intraoperative blood loss; Inhalational anesthesia
• Additional Relevant MeSH Terms: Wounds and Injuries; Otorhinolaryngologic Diseases; Ear Diseases; Tympanic Membrane Perforation; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Anesthetics, Inhalation; Remifentanil; Propofol; Sevoflurane; Isoflurane
• Other Study ID Numbers: TIVA in Ear Surgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No