Inhalational Anesthesia vs TIVA in Endoscopic Tympanoplasty

Early Phase 1

Recruiting

• Conditions: Perforated Eardrum
• Interventions: Drug: Isoflurane Inhalant Product; Drug: Propofol injection; Drug: Remifentanil Injection; Drug: Sevoflurane inhalant product

• Registration Number: NCT05993039
• Lead Sponsor: Our Lady of the Lake Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-15
• Study Start: 2023-09-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-11-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Individuals with anticoagulation disorders
• Those receiving anticoagulation therapy currently

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total Intravenous Anesthesia (TIVA)	Remifentanil Injection	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.
Inhalational Anesthesia	Isoflurane Inhalant Product	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.
Total Intravenous Anesthesia (TIVA)	Propofol injection	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.
Inhalational Anesthesia	Sevoflurane inhalant product	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.

Primary Outcome Measures

Name	Time	Method
Surgical Field Quality	Post-Operative evaluation (within 2 weeks)	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.
Intra-operative blood loss	1-2 hours during surgery	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.

Secondary Outcome Measures

Name	Time	Method
Emergent Delirium and Recovery Time-Riker Scale	Immediately After extubation	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).
Emergent Delirium and Recovery Time-Richmond Scale	Immediately After extubation	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.
Post-operative pain or complications	0-1 hour post-operative	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.

Trial Locations

Locations (1)

Our Lady of the Lake Hospital; 🇺🇸 Baton Rouge, Louisiana, United States