NCT04724759

The Effect of Opioid-Free Anesthesia in TMJ Surgery

The Effect of Opioid-Free Anesthesia in TMJ Surgery: A Prospective Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims is to evaluate the effect of opioid free total intravenous anesthesia on postoperative quality of recovery in patients undergoing oral and maxillofacial surgery (OMF) temporomandibular joint (TMJ) surgery.

Detailed description

This study will enroll 60 patients undergoing TMJ surgery at Massachusetts General Hospital. Anesthetic care will be standardized according to current institutional standards of care. Intraoperative clinicians will not be blinded to group assignment. Patients will be randomized to one of two groups: * Group 1 - Opioid-free Anesthesia Patients: Patients who are not receiving opioids but the total intravenous anesthetic during surgery. * Group 2 - Standard Anesthesia Patients: Patients who undergo the standard of care and receive opioids as part of their anesthetic regimen. Both groups employ strategies that are routinely used as part of standard clinical practice for TMJ surgery. Patients will otherwise receive the institutional standards of care for their surgical procedure and perioperative care. Following intraoperative drug administration patients will be followed until discharge from the PACU to assess study endpoints while in the hospital. At the time of discharge from the PACU, members of the study team will ask the patient to compete a brief survey on their satisfaction with pain management. Patients in this study will be anticipated to be discharged the same day as the surgical procedure. At the time of hospital or PACU discharge, the patient will be provided with a Medication Diary. This will be used to record pain medication administration in the first 48 hours after surgery, as well as any pain or complication they might experience at home.

Conditions

• Temporomandibular Joint Disorders

Interventions

Type	Name	Description
DRUG	Dexmedetomidine / Ketamine / Lidocaine	Patients in this group will receive an infusion of lidocaine, ketamine, or dexmedetomidine supplemented with other intravenous analgesics and intravenous and inhaled anesthetics, as needed clinically. This includes administration of 5 mcg/kg/min of ketamine plus 0.5 - 1.0 µg/kg/hr of dexmedetomidine (Precedex) as a continuous infusion, started from induction to stop one hour before surgery is anticipated to end.

Timeline

• Start date: 2021-06-18
• Primary completion: 2023-04-23
• Completion: 2023-04-23
• First posted: 2021-01-26
• Last updated: 2024-11-21
• Results posted: 2024-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study