Lidocaine Supplement for Minimal Invasive Parathyroid Surgery
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Primary Objective:
1. To determine if the application of lidocaine to the airway will obtund or abolish the laryngeal reflexes. This in turn will lead to a quiescent controlled surgical field.
| Condition | Intervention | Phase |
|---|---|---|
|
Parathyroid Disease |
Drug: Lidocaine Drug: Saline |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Prevention of Laryngeal Reflexes in Minimal Invasive Parathyroid Surgery by the Use of Topical Lidocaine |
- Severity of Airway Interruption [ Time Frame: Assessment made by surgeon during minimally invasive parathyroidectomy surgery ] [ Designated as safety issue: No ]
- Quality of Operative Field [ Time Frame: Assessment made by surgeon during minimally invasive parathyroidectomy surgery ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | June 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Saline
Saline misted into the air breathe during the surgery.
|
Drug: Saline
Saline is misted into the air that you breathe during the surgery.
|
|
Experimental: Lidocaine
Lidocaine misted into the air during the surgery.
|
Drug: Lidocaine
Lidocaine is misted into the air that you breathe during the surgery.
|
Detailed Description:
Lidocaine is a local anesthetic that causes numbness to the throat when misted into the air. This numbness in the throat should stop the urge to clear the throat in the middle of the operation. Therefore, this should stop the interruptions during the surgery.
If you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of 2 groups. Participants in Group 1 will receive the saline mist. This will moisturize and soothe the throat. Participants in Group 2 will receive the lidocaine mist. Lidocaine or saline is misted into the air that you breathe during the surgery. You and your surgeon will not be told which group you were assigned to. At the end of the surgery, your surgeon will answer some questions to help determine if the use of lidocaine or saline is beneficial.
You will be considered off-study once you are sent to the recovery room after surgery.
This is an investigational study. Lidocaine is FDA-approved and commercially available for local anesthesia. If you are in the lidocaine or the saline group. Up to 105 patients will take part in this study. All will be enrolled at M. D. Anderson.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All outpatients scheduled for MIPS at the ACB by Dr N Perrier, Dr D Evans and Dr JE Lee.
Exclusion Criteria:
- Patients who are excluded will be any who require elective endotracheal intubation as a preoperative decision by the anesthesia team. These patients will be those with sleep apnea, BMI>35, uncontrolled gastro esophageal reflux.
- Patients who have a history of allergy/hypersensitivity to lidocaine.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00528502 History of Changes |
| Other Study ID Numbers: | 2006-0147 |
| Study First Received: | September 11, 2007 |
| Last Updated: | December 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Parathyroid Disease Minimal Invasive Parathyroid Surgery MIPS |
Laryngeal Reflexes Lidocaine Saline |
Additional relevant MeSH terms:
|
Parathyroid Diseases Endocrine System Diseases Lidocaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013